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Stryker announces nomination of two new Directors, Sheri S. McCoy and Rajeev Suri

Posted On January 8, 2018 By OrthoSpineNews In Recon, Spine, Top Stories /  

By GlobeNewswire,  January 08, 2018

Kalamazoo, Michigan – January 8, 2018 – Stryker Corporation (NYSE:SYK) announced that Sherilyn (Sheri) S. McCoy and Rajeev Suri have been nominated for election to the Company’s Board of Directors at Stryker’s 2018 Annual Meeting of Shareholders, which is expected to be held on May 2, 2018.  Their successful elections would bring the total size of the Company’s Board to ten members.

Ms. McCoy brings a wealth of healthcare and consumer experience gained during a 30-year career at Johnson & Johnson that included leadership of large medical device, pharmaceutical and consumer businesses.  She is currently Chief Executive Officer of Avon Products, a personal care products company. She has held her current position for five years, and has announced that she will be retiring on March 31, 2018. She is also a member of the Board of Directors of AstraZeneca, a global, science-led biopharmaceutical company.

Mr. Suri is President and Chief Executive Officer of Nokia, a leading global technology company. Mr. Suri has deep technology experience spanning nearly 30 years, most of which have been in leadership roles at Nokia. He has served in his current role at Nokia since 2014 and has engineered a transformation of the company through significant portfolio adjustments, such as the acquisition of Alcatel-Lucent.

“We are excited about the potential to add Sheri and Rajeev to our Board,” said Kevin A. Lobo, Chairman and Chief Executive Officer. “They will bring new perspectives and complementary skills, in addition to rich experiences leading large organizations.  They also both share a passion for healthcare and helping Stryker achieve its mission.”

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com.

Important Additional Information and Where You Can Find It

The Company, its directors and certain of its executive officers may be deemed to be participants in a solicitation of proxies from the Company’s shareholders at its 2018 Annual Meeting of Shareholders in connection with the director nominations disclosed above. Information regarding the Company’s directors and executive officers and their respective interests in the Company, by security holdings or otherwise, is set forth in the Company’s Definitive Proxy Statement for its 2017 Annual Meeting of Shareholders, filed with the Securities and Exchange Commission (the “SEC”) on March 20, 2017, and reports filed by the Company and ownership forms filed by the directors and executive officers with the SEC. The Company will furnish its Definitive Proxy Statement for its 2018 Annual Meeting of Shareholders to shareholders entitled to vote at the meeting and will file a copy with the SEC. The Company urges its shareholders to carefully read the Definitive Proxy Statement for its 2018 Annual Meeting of Shareholders, and any other relevant documents filed by the Company with the SEC, when available because they will contain important information. Shareholders may obtain free copies of the materials referenced above at www.sec.gov or www.stryker.com.

Contacts

For investor inquiries please contact:

Katherine A. Owen, Stryker Corporation, 269-385-2600 or katherine.owen@stryker.com

For media inquiries please contact:

Yin Becker, Stryker Corporation, 269-385-2600 or yin.becker@stryker.com

This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.

The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Stryker Corporation via Globenewswire

This article appears in: News Headlines

Referenced Stocks: SYK

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Spineology Completes First Lateral Post-Market Study Cases Using Novel Implant Design

Posted On January 8, 2018 By OrthoSpineNews In Spine, Top Stories /  

January 08, 2018

ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., an innovator in anatomy-conserving spine surgery, is excited to announce the completion of the first post-market study cases using its recently FDA-cleared Duo™ Lumbar Interbody Fusion System. In October, the company announced the initiation of this prospective, post-market lateral interbody fusion study designed to evaluate patient outcomes. To date, study cases have been completed by Dr. Craig Kuhns, Austin, Texas; Dr. Sandeep Kunwar, Fremont, California; and Dr. Jason Huffman, Napa, California.

The Duo System implant is the first to combine PEEK, titanium and graft containment mesh elements. This design dramatically reduces the access required to implant a device compared to traditional lateral systems. By significantly minimizing the nerve and soft tissue retraction typically required in these surgeries, the company believes the Duo System will reduce the post-operative thigh pain and other complications commonly associated with the lateral approach. In addition to reducing the exposure required for placement, the Duo implant, once filled, creates a large, load-sharing, endplate-conforming graft pack that expands up to 30mm in width to help maintain spinal correction and support fusion.

“The Duo System allows me to efficiently place the implant through a very small access, which reduces trauma to the muscle and neural elements,” said Dr. Sandeep Kunwar. “During placement, the implant can immediately correct spinal deformity. Once in place, the implant is filled with allograft and provides a very large footprint, resulting in excellent stabilization of the segment and a large area for fusion.”

“Thigh-related post-operative complications associated with the lateral approach have been well documented,” said Dr. Craig Kuhns. “Based on my experience, the Duo System has the ability to significantly reduce these complications, which makes for a much easier postoperative course for my patients.”

“The Duo System is intuitively designed,” added Dr. Jason Huffman. “The small, 18mm tubular access portal reduces trauma to soft tissues and neural structures while significantly minimizing tissue creep. It also eliminates the need to position blades, saving me time during the procedure. The instrumentation allows for an efficient, radical discectomy and timely placement of the implant. The reduced access requirements and efficiency of the system both play a role in the reduction of post-operative thigh pain and weakness, and the overall success of the surgery.”

Additional sites nationwide are participating in the Duo System post-market study and are currently completing training or screening patients.

About Spineology Inc.
Spineology Inc. provides innovative, anatomy-conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com.

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com
or
Risdall
Dave Folkens, 651-286-6713
dave@risdall.com

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ConforMIS announces results published in the Journal of Knee Surgery showing 100% of patients treated with iTotal CR achieve mechanical alignment in target range of +/- 3%

Posted On January 5, 2018 By OrthoSpineNews In Recon, Top Stories /  

BILLERICA, Mass., Jan. 04, 2018 (GLOBE NEWSWIRE) — ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that offers joint replacement implants designed and manufactured to fit each patient’s unique anatomy, today announced the publication of a prospective study in The Journal of Knee Surgery, a peer-reviewed orthopedic journal, on December 14, 2017. The study investigated the ability of the iTotal CR Knee Replacement System restoring coronal plane mechanical axis alignment in a patient’s leg.

The study, which was independently performed by Dr. Gary Levengood at Sports Medicine South in Lawrenceville, Georgia, examined 63 consecutive patients he operated on using the ConforMIS iTotal CR implant system and ConforMIS iJig patient-specific instrumentation.  Results in each of the cases were verified using computer-assisted surgery (CAS).  According to the study results, perfect neutral coronal mechanical alignment of 0° was achieved in 84% of patients, with the remaining 16% of patients within +/-2° of neutral.  The patients had an average pre-operative deformity of 5.57° (range 12° valgus to 15°varus), and a post-operative average of 0.18° (range 0-2°) (p<0.0001).  Additionally, while 40 of the 63 patients had pre-operative extension deficits (the inability to fully extend the leg), no patients had postoperative extension deficits.

According to the study, neutral mechanical limb alignment, or alignment within +/- 3°, has previously been linked to better survivorship in TKA, while poor alignment has been linked to higher rates of implant failure. This study’s findings are consistent with those of a previous published study by Ivie et.al. from the Journal of Arthroplasty in 2014, which concluded that the ConforMIS iTotal was 1.8 times more likely to achieve a neutral mechanical alignment as compared to standard off-the-shelf knees.

Based on a review of the published literature, the authors reported that the results observed with the ConforMIS iTotal CR patient-specific, custom-made total knee implant with patient-specific instrumentation were found to be more consistently accurate than previous reports on patient-specific cutting guides used with standard off-the-shelf implants.  The authors noted that, according to the literature, patient-specific cutting guides used with standard off-the-shelf implants resulted in a high percentage of cases with an overall error in mechanical axis alignment greater than a threshold of 3 degrees.  The authors of the study suggest several key differences that may have contributed to the greater accuracy of the iTotal system with its iJig instrumentation compared with the published literature, including the use of a full set of ConforMIS patient-specific jigs with the ConforMIS custom-made implant, and the ability to maintain native medial and lateral offsets of the femur.

“As a surgeon, one of the most important goals to me with any knee replacement, is to achieve a neutral mechanical limb alignment. The inherent variability noted in the literature when using patient-specific jigs with an off-the-shelf implant, where the mechanical alignment too often fell outside of the +/- 3° acceptable range, was the impetus in studying this metric as I began to use this iTotal technology,” said Dr Levengood. “As our data shows, we were able to achieve precise alignment, with absolutely no outliers. Prior to using the ConforMIS iTotal CR, I utilized computer navigation to achieve a reproducible alignment; however, this added substantial time to my procedures and required surgical placement of tracking pins in each patient’s femur and tibia during the operation.  With the iTotal, I am provided a complete operative plan, from the CT scan each patient gets prior to surgery.  Based on these results, I have full confidence in the system to deliver consistent and improved surgical outcomes.”

“This independent study provides compelling new data demonstrating the accuracy of utilizing ConforMIS iJig instrumentation, with its built-in mechanical axis alignment and image guidance, in combination with our individually designed, patient-specific implants,” said Mark Augusti, Chief Executive Officer and President of ConforMIS.  “Importantly, it is consistent with earlier published results.  One of the drawbacks of patient-specific cutting guides when used with standard off-the-shelf implants that are not patient-specific has been the inability to consistently achieve neutral mechanical alignment. Dr. Levengood’s data demonstrate that the ConforMIS iTotal CR system does not share this problem.  This study adds enlightening data and analysis to the growing body of evidence that ConforMIS iJig Instrumentation, when used in conjunction with ConforMIS individually designed, patient-specific iTotal implants, provides superior results compared to other patient-specific instrumentation used with off-the-shelf implants.”

ConforMIS did not provide any economic support for this study.  Dr. Levengood previously has served as an advisor to ConforMIS.

About ConforMIS, Inc.

ConforMIS is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy.  ConforMIS offers a broad line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital.  In recent clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants.  ConforMIS owns or exclusively in-licenses approximately 420 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints.

For more information, visit www.conformis.com.

Cautionary Statement Regarding Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for ConforMIS, including statements about the potential clinical benefits or other impacts and advantages of using customized implants, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our clinical studies, and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent ConforMIS’s views as of the date hereof. ConforMIS anticipates that subsequent events and developments may cause ConforMIS’s views to change. However, while ConforMIS may elect to update these forward-looking statements at some point in the future, ConforMIS specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing ConforMIS’s views as of any date subsequent to the date hereof.

CONTACT:

Kelly Wakelee
kwakelee@berrypr.com
(212)-253-8241

Investor Contact:
Oksana Bradley
ir@conformis.com
(781) 374-5598

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/728a786b-f59f-4fb5-947c-5e772c9ea94f

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/0a97a95b-0207-4472-8c47-59d8a3b3b3ba

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/cb3cb524-e1b7-4e82-a02a-4d4dadbc0177

 

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NuVasive Extends First-Of-Its-Kind Porous PEEK Interbody To TLIF And PLIF Procedures

Posted On January 4, 2018 By OrthoSpineNews In Spine, Top Stories /  

SAN DIEGO, Jan. 4, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, announced today the launch of the Company’s COALESCETM Thoracolumbar Interbody Fusion Device as well as FDA 510(k) clearance for expanded indications of its COHERE® Cervical Interbody Fusion Device. The launch and updated claims follow the NuVasive September 2017 acquisition of Vertera Spine, developers of highly innovative interbody implants for spinal fusion using patented porous polyetheretherketone (PEEK) technology.

The NuVasive Advanced Materials Science (AMS) Portfolio includes Porous PEEK™ and Modulus® Titanium interbody implants that are engineered for enhanced osseointegration and biomechanical properties when compared to solid implants with smooth or rough surfaces. Based on animal studies, COALESCE and COHERE provide a unique three-dimensional Porous PEEK architecture to help elicit and encourage bone ingrowth. The technology used to develop these devices utilizes a proprietary processing method that introduces porous structure without compromising implant strength.

“Our strategy in building our AMS portfolio is to provide unprecedented, innovative technologies that enhance the surface, structure and visualization properties of these implants,” said Gregory T. Lucier, chairman and chief executive officer of NuVasive. “Our launch of COALESCE and the expanded clearance of COHERE and COALESCE are all part of our continued commitment to bring disruptive technology to market and investment into our comprehensive AMS portfolio, which converge to provide a better surgical experience and improve patient quality of life.”

COALESCE is now commercially available for TLIF and PLIF procedures in multiple footprint, height and lordotic options, and is magnetic resonance compatible. Following its recently cleared 510(k), COALESCE indications have been expanded to include use for one or two adjacent levels in the thoracolumbar spine (T1– S1) with both autograft and allograft for treatment of degenerative disc disease and degenerative spondylolisthesis as well as multi-level degenerative scoliosis. The device previously received FDA 510(k) clearance for use in anterior, transforaminal, posterior and lateral lumbar interbody fusion procedures.

The expanded FDA 510(k) indications for COHERE allow it to be used at multiple levels in the cervical spine (C2 – T1) with both autograft and allograft. In addition, COHERE received a new ICD code from the Center of Medicare & Medicaid Services (CMS) in October. COHERE is the only product approved for use with the new code, signifying CMS’ recognition of the innovation and potential clinical and tracking benefits of using Porous PEEK technology.

“Patients can gain significant pain relief and improved functional outcomes through the stabilization and fusion of the degenerated spinal motion segment,” said Dr. Kenneth Burkus, orthopaedic surgeon at The Hughston Clinic. “COHERE and COALESCE contribute to these outcomes by retaining the biomechanical properties necessary for intradiscal spinal applications, while helping facilitate osseointegration and bone growth. The use of these new Porous PEEK implants may enhance fusion and limit the risk of stress-shielding, subsidence and implant failure.”

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA® platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

 

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

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OrthoPediatrics Corp. Expands PediPlates® Franchise with Titanium System

Posted On January 4, 2018 By OrthoSpineNews In Extremities, Top Stories /  

WARSAW, Ind., Jan. 03, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, is pleased to announce the launch of Titanium PediPlates®, the Company’s 24th surgical system. The titanium implant system expands OrthoPediatrics’ already comprehensive physeal tethering offering and includes both O-Plates and I-Plates as well as solid and cannulated low-profile screws. As a market leader in guided growth, OrthoPediatrics’ PediPlates technology harnesses the power of the growth plate through a simple, minimally invasive, and reversible tethering technique.

Joe Hauser, OrthoPediatrics’ Vice President of Trauma and Deformity Correction, noted that titanium PediPlates provide another correction option to pediatric orthopedic surgeons worldwide. “Adding a titanium offering to OrthoPediatrics’ market leading PediPlates physeal tethering franchise expands physicians’ treatment options, especially in patients who have a nickel allergy. The launch of our 24th surgical system strengthens our strategy to provide pediatric orthopedic surgeons with superior options for treating children.”

About PediPlates®
The PediPlates® system, which includes the I-Plate, O-Plate, and Delta Plate, provides a physeal tethering technique that does not disrupt the integrity of the physis, or growth plate. It features simple plate and screw constructs that span the growth center and restrain the physis by inhibiting growth where the plates and screws are applied. The system also features stainless steel plates and screws, which provide excellent strength, resistance to breakage, and ease of removal.

About OrthoPediatrics Corp. 
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 24 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, complex spine and ACL reconstruction procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 35 countries outside the United States.

Investor Contacts
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024
tbui@theruthgroup.com / epoalillo@theruthgroup.com

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Zimmer Biomet Announces FDA Clearance of the Sidus® Stem-Free Shoulder System

Posted On January 3, 2018 By OrthoSpineNews In Regulatory, Top Stories /  

WARSAW, Ind., Jan. 3, 2018 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced it has received U.S. Food and Drug Administration (FDA) clearance for the Sidus® Stem-Free Shoulder system as a total shoulder arthroplasty solution for patients with good bone stock that have either osteoarthritis, post-traumatic arthrosis, focal avascular necrosis of the humeral head or who had previous surgeries of the shoulder that do not compromise the fixation. The Sidus Stem-Free Shoulder system is designed to anatomically restore a patient’s anatomy, preserve bone stock and allow for improved pre to post-operative patient outcomes1,2. The Sidus system will be available in the United States beginning in the First Quarter of 2018.

“The Sidus Stem-Free Shoulder system offers a novel approach to total shoulder arthroplasty requiring minimal bone resection,” said Dr. Ryan Krupp, orthopaedic surgeon at Norton Orthopedic Specialists in Louisville, Ky. “The Sidus system is designed to reduce pain and restore range of motion and is clinically proven to help suitable patients.”1,2

“The FDA clearance of the Sidus Stem-Free Shoulder system comes at a time when Zimmer Biomet is accelerating the pace of innovation,” said Bryan C. Hanson, Zimmer Biomet President and Chief Executive Officer. “We launched Sidus in Europe in 2012 and initiated a clinical study in the U.S. in 2015. During that time, the product has demonstrated strong clinical performance. The addition of the Sidus system to Zimmer Biomet’s U.S. portfolio reinforces the Company’s leadership in the innovation of shoulder solutions.”

About Zimmer Biomet

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com, or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Cautionary Statement Regarding Forward-Looking Statements
This release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes.  Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially.  For a list and description of some of such risks and uncertainties, see Zimmer Biomet’s periodic reports filed with the U.S. Securities and Exchange Commission (SEC).  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC.  Forward-looking statements speak only as of the date they are made, and Zimmer Biomet disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.  Readers of this release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate.  This cautionary statement is applicable to all forward-looking statements contained in this release.

ZBH-Corp

1 Multicenter Trial of the Sidus® Stem-Free Shoulder Arthroplasty System (Protocol CIU2012-12E/G130026, “IDE”).

2 Sidus® Stem-Free Shoulder: A Multicenter, Prospective, Non-Controlled Post Market Clinical Follow-up Study (Clinical Investigation Plan CME2012-01E, “PMCF”).

SOURCE Zimmer Biomet Holdings, Inc.

Related Links

http://www.zimmer.com

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Multi-center Study on SImmetry Sacroiliac (SI) Joint Fusion Shows Significant Reduction in Low Back Pain and Opioid Use at 6 Months

Posted On January 2, 2018 By OrthoSpineNews In Spine, Top Stories /  

MINNETONKA, Minn., Jan. 2, 2018 /PRNewswire/ — Zyga Technology, Inc., a medical device company focused on the design, development and commercialization of minimally invasive devices to treat underserved conditions of the lumbar spine, today announced publication of clinical outcomes for the first 50 patients in the EVoluSIon (EVSI) Clinical Study. This prospective, 40-site, 250-patient trial will evaluate long-term fusion and pain reduction in patients receiving SImmetry® Sacroiliac Joint Fusion.

At 6 months, mean low back pain as measured on a 100-point Visual Analog Scale (VAS) demonstrated a significant reduction from 76.2 pre-operatively  to 35.1 (54% reduction, p<0.0001), with 72% of patients attaining the minimal clinically important difference (MCID, ≥20 point improvement). While pain and disability improvement is comparable to similar studies, the reduction in opioid use (55%) was much greater than previously reported in other studies. Additional follow-up will be performed at 12- and 24-months to assess the presence of bony fusion across the joint via CT imaging as well as ongoing pain reduction.

“It is very exciting to see prospective, multi-center clinical data reaffirm the positive feedback I’ve received from my patients over the past few years,” said Ali Araghi, D.O., an orthopedic surgeon at Core Institute in Phoenix, Ariz. and lead author of the publication. “As a physician working with patients who are in significant pain, it is also incredibly meaningful to know I have a surgical option that can reduce the need for opioid medications. Longer-term follow-up and CT imaging will be important to demonstrate the longevity of these results, but this is very encouraging for our first look at the data.”

Earlier this year, the Company released results of a 19-patient, prospective, multi-center study of Minimally Invasive Sacroiliac Joint Fusion Surgery with Decortication. At 24 months post-op, 94 percent of patients had evidence of bridging bone across the SI joint, with 83 percent categorized as solid fusion. Of patients with solid fusion, 88 percent of the joints were fused within the area of decortication, demonstrating the importance of this step in achieving fusion. In addition to fusion, the study demonstrated a 73 percent reduction in average pain. The EVSI study is designed to build on the findings of this study.

The Centers for Disease Control and Prevention lists back problems as the second most common cause of disability in U.S. adults[i]. It has been reported that approximately 20 percent of all chronic low back pain derives from the sacroiliac joint[ii].

About Zyga Technology, Inc.

The company is marketing the SImmetry® Sacroiliac Joint Fusion System, a minimally invasive procedure intended for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The SImmetry System is known for its ability to create a true SI joint arthrodesis, including decortication, bone grafting and fixation with a threaded implant. For more information, visit zyga.com.

[i] Centers for Disease Control and Prevention. Prevalence of disabilities and associated health conditions among adults—United States, 1999. JAMA. 2001; 285(12):1571-1572.
[ii] Cohen SP et al. Sacroiliac Joint Pain: A Comprehensive Review of Epidemiology, Diagnosis and Treatment. Expert Rev Neurother. 2013; 13(1):99-116

CONTACT:
Maggie Wallner
Tel 952 698 9953
mwallner@zyga.com

SOURCE Zyga Technology, Inc.

Related Links

http://www.zyga.com

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SI-BONE, Inc. Announces BCBS Association Raises Clinical Evidence Rating for MIS SI Joint Fusion

Posted On January 2, 2018 By OrthoSpineNews In Spine, Top Stories /  

SAN JOSE, Calif., Jan. 2, 2018 /PRNewswire/ — SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), a minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that Blue Cross Blue Shield Association (BCBSA), after an extensive review of all existing peer-reviewed published clinical safety and effectiveness data, has assigned triangular implants for SI joint fusion a “Moderate” quality evidence recommendation. The BCBSA rating system encompasses a four-level rating scale of Substantial, Moderate, Low to None and Uncertain. In order for a technology to receive a moderate or substantial rating, the clinical evidence must be sufficient to determine the effects of the technology on health outcomes with confidence. The BCBSA updated technology assessment states that for individuals with common disorders affecting the sacroiliac joint who are treated with sacroiliac fusion/fixation with a triangular implant, the evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. The evidence used to develop the upgraded assessment was developed exclusively using the patented triangular iFuse Implants, which have been commercially available since 2009. The updated assessment further states that for patients with SI joint pain, the evidence is insufficient for treatment with therapeutic corticosteroid injections, radiofrequency ablation or cylindrical threaded implants.

The evidence required to establish a sufficient effect on health outcomes typically includes:

Consistent results from well-designed, well-conducted studies in clearly-defined populations.
Well designed and conducted studies generally controlled for bias through random allocation of participants; blinded assessment of outcomes; minimizing loss to follow-up; and complete reporting of results. Study populations are representative of the population of clinical interest. Study size is adequate to test the hypothesis and assumptions for calculating study power are clearly reported.
Studies assessing the effects of the technology on health outcomes, including both the beneficial and harmful effects on length of life, quality of life and ability to function.
Evidence from effectiveness studies or post-marketing studies that confirm that the observed effects of the intervention are generalizable outside the research setting.
Evidence from effectiveness studies or post-marketing studies to assess long term effects of the technology on health outcomes.

Clinical study data available through a curated open data access source.
The Blue Cross and Blue Shield Association is a national federation of 36 independent, community-based and locally-operated Blue Cross and Blue Shield companies that collectively provide healthcare coverage for more than 106 million members across all 50 states, the District of Columbia and Puerto Rico.

Daniel Cher, MD, Vice President of Clinical Affairs at SI-BONE commented, “there is abundant evidence showing that the sacroiliac joint is a significant contributor to lower back pain and that common types of SI joint dysfunction can be effectively treated with a minimally invasive surgical procedure using the triangular iFuse Implant, which we brought to market in 2009. That said, the SI joint has been under-diagnosed and under-treated for decades and our philosophy has been to take a high level scientific approach, including well-designed and well-executed clinical studies so that the data from these studies could stand on their own for educational, clinical and patient purposes.”

About SI joint dysfunction
The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain 1-4, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.5 SI joint dysfunction is often misdiagnosed and the resulting pain can be incorrectly attributed to other causes. SI joint dysfunction can be identified when a patient points to their source of pain directly over the posterior superior iliac spine (PSIS), known as the Fortin Finger Test, combined with a number of positive provocative maneuvers to stress the SI joint and elicit the pain, followed by image-guided diagnostic injections to confirm the diagnosis. The SI joint is the largest of the eight major joints in the human body and the last to have a proven surgical treatment. The iFuse Implant, first FDA-cleared in 2009, is the only device for treatment of SI joint dysfunction supported by significant published clinical evidence, including level 1 trials, showing safety and durable effectiveness, including providing lasting pain relief. The iFuse Implant was designed specifically to withstand the extreme forces resulting from load-bearing and the unique rotational and translational motion of the SI joint referred to as nutation, and is supported by more than 50 peer-reviewed publications including two Level 1 randomized controlled trials (www.si-bone.com/results).

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading medical device company that has developed the iFuse Implant System, a proprietary minimally invasive surgical implant system to fuse the sacroiliac joint to treat common disorders of the joint that can cause lower back pain. Patients with certain types of sacroiliac joint dysfunction experience pain that can be debilitating.

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit: www.si-bone.com/risks

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2018 SI-BONE, Inc. All Rights Reserved. 10037.010218

1. Bernard TN, Kirkaldy-Willis WH. Recognizing Specific Characteristics of Nonspecific Low Back Pain. Clin Orthop Relat Res. 1987;217:266–80.
2. Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
3. Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
4. Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
5. DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.

SOURCE SI-BONE, Inc.

Related Links
http://www.si-bone.com

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Bone Index Ltd. Announces AMA Issues New Reimbursement Code for Bindex Osteoporosis Measurement

Posted On January 2, 2018 By OrthoSpineNews In Extremities, Top Stories /  

HELSINKI, Jan. 2, 2018 /PRNewswire/ — Bone Index Ltd., one of Europe’s top new manufacturers of medical devices, announces that the American Medical Association (AMA) has issued a new Category III CPT® code* for Bindex® measurement to help physicians in diagnosing osteoporosis.

“In osteoporosis screening and diagnostics area, it has taken about 20 years since the last new code and therefore this new CPT code is a huge step for healthcare operators to provide highly needed osteoporosis examinations. This is also very strong evidence that Bindex is a new and unique medical device which provides significant improvement in osteoporosis screening and diagnostics in US,” says Bone Index’s CEO, Dr. Ossi Riekkinen.

Bindex® point-of-care device measures the cortical bone thickness of the tibia and the algorithm calculates the Density Index, a parameter which estimates bone mineral density at the hip as measured with DXA. Bindex detects osteoporosis with 90% sensitivity and specificity and will significantly help physicians with diagnosis.

Undiagnosed osteoporosis is a worldwide challenge. In the US alone osteoporosis is responsible for two million broken bones every year, costing over 19 billion dollars. Experts forecast that by 2025, the costs will rise to 25.3 billion dollars. One of the biggest challenges is the limited availability of osteoporosis diagnostics since bone density scans are mostly performed in hospitals with large DXA X-ray machines that entail high costs. “This is why Bindex® is a game-changer,” says Dr. Riekkinen.

Bindex® has a total of 19 patents globally including the US, China, Japan and large European countries. “Now Bindex is used by the US’s leading provider of direct to consumer preventive health screenings, Life Line Screening, and in addition, for example, neurosurgeries are using Bindex as a pre-operative measurement. The overall aim is to prevent osteoporotic fractures and improve the quality of life for families in the US,” Dr. Riekkinen concludes.

For more information:

Bone Index Ltd.
Dr. Ossi Riekkinen
CEO
ossi.riekkinen@boneindex.fi
+358-50-363-2797
www.bindex.fi/en/

*0508T: Pulse-echo ultrasound bone density measurement resulting in indicator of axial bone mineral density, tibia. Effective date July 1, 2018. https://www.ama-assn.org/sites/default/files/media-browser/public/cpt/cpt-category3-codes-descriptors.pdf

About Bone Index:

Founded in 2011 and based in Kuopio, Bone Index Finland Ltd. specializes in the development of measuring devices for osteoporosis screening and diagnosis.

This information was brought to you by Cision http://news.cision.com

http://news.cision.com/bone-index/r/bone-index-ltd–announces-american-medical-association-issues-new-reimbursement-code-for-bindex-oste,c2424125

The following files are available for download:

http://news.cision.com/bone-index/i/bindex-kuva,c2314687

Bindex kuva

SOURCE Bone Index

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FDA permits marketing of device to treat diabetic foot ulcers

Posted On December 28, 2017 By OrthoSpineNews In Regulatory, Top Stories /  

SILVER SPRING, Md., Dec. 28, 2017 /PRNewswire-USNewswire/ — Today, the U.S. Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers.

“Diabetes is the leading cause of lower limb amputations,” said Binita Ashar, M.D., director of the division of surgical devices in FDA’s Center for Devices and Radiological Health. “The FDA is dedicated to making technologies available that can help improve the quality of life for those with chronic diseases. Additional options for successfully treating and healing ulcer wounds may help prevent lower limb amputations.”

An estimated 30.3 million people in the United States have been diagnosed with diabetes, according to the Centers for Disease Control and Prevention. Diabetes damages blood vessels and nerves, particularly in the feet, and can lead to severe infections that are difficult to treat. About 25 percent of people with diabetes will experience a foot ulcer in their lifetime. Amputation is sometimes necessary when circulation is so poor that a foot ulcer fails to heal or when treatment fails to stop the spread of an infection.

The Dermapace System is intended to be used in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2 (about the size of a soda can top) which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The Dermapace System is an external (extracorporeal) shock wave system that uses pulses of energy, similar to sound waves, to mechanically stimulate the wound. The device is intended for adult patients (22 years and older), presenting with diabetic foot ulcers lasting for more than 30 days, and should be used along with standard diabetic ulcer care.

The FDA reviewed clinical data from two multi-center, randomized, double-blind studies with a total of 336 diabetic patients receiving either usual care, which includes wet-to-dry dressings or debridement (removal of damaged tissue) as needed, plus the Dermapace System shock wave therapy or usual care plus non-working (sham) shock wave therapy. Both patient groups included those with poorly controlled and well-controlled blood glucose levels.

The patients who had between one and seven treatments with the Dermapace System showed an increase in wound healing at 24 weeks with a 44 percent wound closure rate. Those patients treated with the sham shock wave therapy showed a 30 percent wound closure rate during the same time period.

The most common side effects observed were pain during application of the device, local bruising and numbness, migraines, nausea, fainting, wound infection, infection beyond the wound (cellulitis, osteomyelitis) and fever.

The Dermapace System was reviewed through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices of a new type for which there is no legally marketed predicate device to which the device can claim substantial equivalence. This action also creates a new regulatory classification that would allow future devices to go through the FDA’s 510(k) process, whereby devices can demonstrate substantial equivalence to this predicate device.

The FDA permitted marketing of the Dermapace System to Sanuwave, Inc.

More information:

FDA: Recently Approved Devices

FDA: De novo pathway

FDA: Diabetes information for consumers

CDC: Diabetes

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Stephanie Caccomo, 301-348-1956, Stephanie.caccomo@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

Related Links
http://www.fda.gov

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