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MICRO INVASIVE EXPANDABLE TECHNOLOGY AT NASS 2017

Posted On October 17, 2017 By OrthoSpineNews In Spine /  

Huntley, IL, October 17, 2017–

Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that it will be participating in the 32nd North American Spine Society (NASS) Annual Meeting, taking place in Orlando, October 24-27th, 2017. The meeting is expected to attract over 3,000 surgeons and other healthcare professionals from across the globe.

Life Spine is excited to showcase its Procedural Solutions Product Portfolio highlighted by Micro Invasive Expandable Technology.

Life Spine’s Micro Invasive Expandable Technology is a series of innovative implants that offer surgeons various methods of expansion. ProLift® Expandable TLIF/PLIF Spacer System expands cephalad/caudal for maximum disc height restoration and decompression of neural elements. TiBOW™ Expandable TLIF Spacer System expands anterior/posterior for maximum endplate coverage and stability. LONGBOW® Lateral Expandable Spacer System, winner of the 2016 RYOrtho Innovations Award, is an anterior/posterior expanding interbody designed to minimize psoas disruption while maximizing endplate coverage.

ProLift® and TiBOW™ Expandable Spacer Systems incorporate OSSEO-LOC™ Titanium Surface Treatment Technology that creates a unique osteophylic surface architecture designed to maximize boney on-growth potential. OSSEO-LOC is featured on other key Life Spine implants including PLATEAU®-C Ti, PLATEAU-Z Ti, PRO-LINK® Ti, and PLATEAU Ti, providing surgeons with a full portfolio of titanium solutions.

Life Spine will be presenting its Micro Invasive Expandable Technologies, as well as their full procedural solutions portfolio at booth #1109 during the 2017 NASS conference.

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Camber Spine Announces Surgeon Presenters For NASS 2017

Posted On October 17, 2017 By OrthoSpineNews In Spine /  

WAYNE, Pa., Oct. 17, 2017 /PRNewswire/ — Camber Spine is pleased to announce that Dr. John Malloy IV, D.O. of East Coast Orthopaedics and Dr. Luis E. Duarte, M.D. of Shannon Medical Center will be featured presenters for the company during North American Spine Society’s 2017 Annual Meeting to be held in Orlando, Florida later this month. Camber Spine is focusing on two quickly-growing subsegments within spine: SI Joint Disease Diagnostics and Treatment and Anterior to Psoas (ATP) Lumbar Approach for Fusion.

Each surgeon will be leading daily talks at the Camber Spine booth (550), as well as a lab on the show floor as part of the NASS Surgical Innovation Lab series. Dr. Malloy will be building off of his popular presentation from ISASS 2017. He will discuss how Camber Spine’s sacroiliac fusion products, PROLIX™ and SICONUS™, provide direct visualization and maximized fusion in the treatment of sacroiliac pain. Dr. Duarte will be discussing Right-Sided vs. Left-Sided Anterior to Psoas Approaches and the benefits of the newly FDA-cleared SPIRA™ Open Matrix ALIF.

“We are honored to have two well-esteemed surgeons who are leading innovation in alternative approaches to traditional fusion procedures,” stated Daniel Pontecorvo, Founder and CEO of Camber Spine Technologies. “Their enthusiasm for driving surgical advances aligns with Camber’s vision to solve surgeon frustrations through innovation.”

Sacroiliac Fusion by Camber Spine Technologies is a two-step minimally invasive procedure which consists of the implantation of Prolix™, a machined allograft implant, through direct visualization and a supplemental lateral fixation of the SI Joint using Siconus™ bone screws. The combined use of Prolix™ SI Joint Fusion System and Siconus™ SI Joint Fixation System may be the only MIS SI Joint Fusion technology to foster a True Fusion of the SI Joint.

SPIRA™ Open Matrix ALIF was designed specifically to increase fusion rates and stabilization. The spiral support arches decrease subsidence by load sharing over the entire endplate, while also maximizing bone graft capacity. The Surface by Design™ technology is a deliberately designed roughened surface that facilitates bone growth through an optimized pore diameter, strut thickness and trabecular pattern.

Camber Spine NASS 2017 Presentation Schedule
Wednesday, October 25th
 9:15AM: New Techniques For Fusion and Fixation Of The SI Joint with Dr. John Malloy IV, D.O.
11-1PM: Prolix/Siconus Lab with Dr. John Malloy IV, D.O.
Thursday, October 26th
9:30AM: New Frontiers in MIS Spine Surgery; Advanced Implants and Anteriorpsoas/Anterior Lumbar approaches with Dr. Louis Duarte, M.D.
Thurs 11-1 Spira Lab with Dr. Louis Duarte, M.D.

*For more information or to register please contact Mindy Elgart at melgart@cambermedtech.com

About John Malloy IV
Dr. John (Sean) P. Malloy is an orthopedic surgeon specializing in Lumbar and Cervical surgery as well as minimally invasive procedures used to treat musculoskeletal and spinal injuries or disorders. He completed his orthopedic surgery residency at Pinnacle Health Hospital System and Penn State Hershey medical center where he was named Chief Resident in the Department of Orthopedic Surgery. He has authored numerous publications in the orthopedic and spinal surgery literature and has presented and continues to speak at conferences both locally and on a national level.

About Luis Duarte
Dr. Luis E. Duarte, MD is a practicing Neurosurgeon in San Angelo, TX. Dr. Duarte graduated from Jefferson Medical College of Thomas Jefferson University in 1987 and has been in practice for 30 years. He completed a residency at Hahnemann University Hospital. He currently practices at Brain & Spine Institute and is affiliated with Shannon Medical Center.

About Camber Spine Technologies, LLP
Camber Spine Technologies, LLP, is a fast-growing musculoskeletal implant company founded in 2010 bringing innovative, best-in-class products to the market, providing surgeons and their patients with better treatment options. Camber Spine Technologies, LLP is an ISO 13485 certified medical device company located in Wayne, Pennsylvania, that markets a line of proprietary musculoskeletal products nationwide through its exclusive distributor, S1 Spine. The company is committed to delivering surgeon inspired new technologies to the spine market.

For further information please visit www.cambermedtech.com. For inquiries about any of our products or distribution opportunities please call 484-427-7060.

All of Camber Spine Technologies’ products are proudly MADE IN THE USA.

SOURCE Camber Spine Technologies

Related Links

http://cambermedtech.com

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Leader of Johnson & Johnson 3D Printing Center of Excellence Outlines Advantages of Customized Knee Implants

Posted On October 16, 2017 By OrthoSpineNews In Recon /  
Photo: ConforMIS 3D Printing and Additive Manufacturing Facility; Wilmington, MA

BILLERICA, Mass., Oct. 16, 2017 (GLOBE NEWSWIRE) — ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that offers joint replacement implants customized to fit each patient’s unique anatomy, today announced that, while the industry has begun to acknowledge the value of customized knee replacement implant systems compared to traditional off-the-shelf implant systems, it has obtained additional positive clinical data regarding the performance of its customized partial knee replacement implants.

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/38f395f7-6e0c-415c-b971-eafda91979ec

Recently, Sam Onukuri, head of Johnson & Johnson’s 3D Printing Center of Excellence, acknowledged the advantages of customized knee implants and instruments that are developed based on a CT or MRI scan of a patient’s anatomy.  In an interview generally discussing the advantages of additive manufacturing published in GE Reports by General Electric (GE) and in an “Employee Spotlight” article published by Johnson & Johnson, Onukuri noted the potential advantages of customized knee implants that may reduce both “pain and the recuperation time” compared to traditional off-the-shelf implant systems that come in a limited range of sizes.  “Physicians make every effort to find the implant that fits best,” Onukuri says. “But it’s never a perfect match, and the same is true for the tools. As a result, the surgery takes longer — and so can healing and recovery — and the fit may not be perfect.” On the other hand, Onukuri noted that “customized solutions” based on patient CT or MRI scans “can achieve an exact fit for the joint.”

While the orthopedic industry researches potential customized alternatives to traditional off-the-shelf implant technology, ConforMIS continues to develop a growing body of positive clinical data regarding its existing customized knee implants.  Most recently, in a study evaluating knee strength and mechanics that compared healthy control patients to those with either a modern off-the-shelf total knee replacement (TKR) or a customized bi-compartmental knee replacement (BKR), the authors concluded that the “study shows that BKR patients exhibit better strength and mechanics while performing activities of daily living.”  According to the study results: the TKR group walked significantly slower when compared to both the BKR group and healthy controls (p < 0.05); the TKR knee had less peak extensor moment at stance than both the BKR and healthy control knees (p < 0.05); and both the BKR and healthy control knees displayed larger internal rotation at stance than that of the TKR knee (p < 0.05).  The results of the study, for which ConforMIS provided financial support, were published online by International Orthopaedics on September 4, 2017.

“We are very pleased that the industry is now beginning to recognize the advantages and potentially transformative nature of customized knee implant and instrumentation solutions,” said Mark Augusti, Chief Executive Officer and President of ConforMIS.  “ConforMIS has been a champion of customized implant technology for over a decade, and the body of clinical data demonstrating both the clinical and the economic advantages of customized total and partial knee implant systems continues to grow.”

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 450 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 transformative nature of customized implant systems, the economic 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 product development and commercialization efforts, 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.

 

The photo is also available via AP PhotoExpress.

CONTACT:

Beth Best
beth.best@conformis.com
(781) 345-9032

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

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TransEnterix Announces US 510(k) FDA Clearance for Senhance Surgical Robotic System

Posted On October 16, 2017 By OrthoSpineNews In Regulatory, Robotics, Top Stories /  

October 13, 2017

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, today announced the Company has received FDA 510(k) clearance for the Senhance™ Surgical Robotic System.

“The clearance of the Senhance System in the US is a milestone in the progress of robotics and is expected to deliver improvement in the efficacy, value and choices offered to patients, surgeons and hospitals,” said Todd M. Pope, President and Chief Executive Officer of TransEnterix. “Millions of surgical procedures in the US are performed each year laparoscopically with basic manual tools that limit surgeons’ capability, comfort and control. New choices are needed that enhance the senses, control and comfort of the surgeon, minimize the invasiveness of surgery for the patient, and maximize value for the hospital. Senhance is this new choice.”

With this clearance, the Senhance becomes the first new market entrant into the field of abdominal surgical robotics since 2000. Using the system, a surgeon directs small surgical instruments and a camera with precise movements and comfort. The system builds on the foundation of laparoscopy and features the security of haptic feedback and eye-sensing camera control for the first time in a robotic surgery platform. Additionally, the Senhance utilizes an open architecture, which allows hospitals and surgeons to leverage existing technology investments within the operating room ecosystem. The system is specifically engineered to manage operative costs effectively, making robotic surgery cost-effective on a per-procedure basis through the use of fully reusable instruments.

“Surgeons are approaching the boundaries of minimally invasive care performed with handheld manual instruments and cameras, and are seeking new technologies that will allow us to advance beyond these boundaries,” said Dr. Steve Eubanks, a general surgeon and Executive Director of Academic Surgery at Florida Hospital. “The future will be driven by the appropriate use of robotics and information tools in the operating room. The Senhance platform grants laparoscopic surgeons robotic precision, control of our vision, and haptic feedback while minimizing procedural costs, and is a welcome revolution in our field.”

TransEnterix will host a conference call on Tuesday, October 17, 2017 at 8:00 AM ET to discuss the FDA clearance of the Senhance. To listen to the conference call on your telephone, please dial (844) 804-5261 for domestic callers or (612) 979-9885 for international callers, reference conference code 1546349. To access the live audio webcast or archived recording, use the following link http://ir.transenterix.com/events.cfm. The replay will be available on the Company’s website.

About TransEnterix

TransEnterix is a medical device company that is pioneering the use of robotics to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options. The Company is focused on the commercialization of the Senhance™ Surgical Robotic System, a multi-port robotic system that brings the advantages of robotic surgery to patients while enabling surgeons with innovative technology such as haptic feedback and eye sensing camera control. The Company also developed the SurgiBot™ System, a single-port, robotically enhanced laparoscopic surgical platform. The Senhance Surgical Robotic System has received FDA 510(k) clearance and has been granted a CE Mark. For more information, visit the TransEnterix website at www.transenterix.com.

Forward-Looking Statements

This press release includes statements relating to the Senhance™ Surgical Robotic System and our current regulatory and commercialization plans for this product. These statements and other statements regarding our future plans and goals constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether the Senhance Surgical Robot will deliver improvement in the efficacy, value and choices offered to patients, surgeons and hospitals, whether the Senhance System will maximize value for hospitals and whether the Senhance platform grants laparoscopic surgeons robotic precision, control of surgeon’s vision and haptic feedback while minimizing procedural costs. For a discussion of the risks and uncertainties associated with TransEnterix’s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K filed on March 7, 2017 and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

For TransEnterix, Inc.
Investor Contact:
Mark Klausner, +1-443-213-0501
invest@transenterix.com
or
Media Contact:
Mohan Nathan, +1-919-765-8400
media@transenterix.com

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Anika Announces Regulatory Approval for MONOVISC® in Australia

Posted On October 16, 2017 By OrthoSpineNews In Extremities, Regulatory /  

October 16, 2017

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced that regulatory authorities in Australia granted approval to MONOVISC®, Anika’s single injection viscosupplement for the treatment of pain associated with osteoarthritis of all synovial joints, including the hip and knee. MONOVISC is commercially available in over twenty countries, including the United States, Canada, and various European countries. MONOVISC also recently received approval in the Asia-Pacific countries of India and Taiwan. Anika intends to further expand MONOVISC into additional international markets in 2018.

“The Asia-Pacific region presents an important growth opportunity for our global orthobiologics franchise, and we’re excited to bring MONOVISC to patients in Australia and New Zealand,” said Charles H. Sherwood, Ph.D., Chief Executive Officer of Anika Therapeutics. “With this approval, MONOVISC is poised to become the most widely available single-injection viscosupplement in the world and will be a key driver in growing global market share.”

The global expansion of MONOVISC is an important international orthobiologics revenue driver for Anika, and Australia and New Zealand represent a large and growing market opportunity. Anika has a multi-year, exclusive distribution agreement with Surgical Specialties Pty. Ltd. to market MONOVISC in Australia and New Zealand. Established in 2006, Surgical Specialties is an independent distributor of innovative medical devices, with a team of over 70 people in sales offices throughout Australia and New Zealand. Surgical Specialties is an ideal partner for Anika with its established relationships with leading orthopaedic surgeons and sports physicians, a successful track record, and a highly skilled and dedicated national sales force.

About MONOVISC

MONOVISC is Anika’s next-generation HA-based therapy for treating osteoarthritis that features enhanced durability in a safe, easy-to-use, single injection regimen. MONOVISC is made from highly purified, non-animal, natural hyaluronan. Hyaluronan occurs naturally throughout the body, especially in articular cartilage, synovial fluid in joints and in the skin. For more information about MONOVISC, please visit www.monovisc.com.

About Anika Therapeutics, Inc.

Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative cartilage repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC®, MONOVISC, and CINGAL®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST®, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

Forward-Looking Statements

The statements made in the last sentences of the first and second paragraphs and first sentence of the third paragraph of this press release, which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to the Company’s international expansion plans for MONOVISC, the market for the Company’s products in foreign countries, including Australia and New Zealand, and the status of MONOVISC as a global revenue driver for the Company. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks, uncertainties, and other factors. The Company’s actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Company’s ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company’s ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company’s research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company’s ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company’s ability to provide an adequate and timely supply of its products to its customers; and (x) the Company’s ability to achieve its growth targets. Additional factors and risks are described in the Company’s periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC’s website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.

Contacts

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, 781-457-9000
Chief Financial Officer
or
For Media Inquiries:
Pure Communications
Sonal Vasudev, 917-523-1418
sonal@purecommunicationsinc.com

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NuVasive Receives Expanded FDA 510(k) Clearance For TLX Interbody System Used In TLIF Procedures

Posted On October 16, 2017 By OrthoSpineNews In Regulatory, Spine /  

SAN DIEGO, Oct. 16, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced an expanded U.S. Food and Drug Administration (FDA) 510(k) clearance of the Company’s TLX interbody system, used in the leading spinal fusion surgery. New clearance introduces an expandable 20 degree cage and broader indications for use, including use with allogeneic bone graft and use in additional levels of the spine.

The TLX interbody system is a market-leading solution that is inserted through a conventional transforaminal lumbar interbody fusion (TLIF) approach. NuVasive developed a minimally invasive approach for the TLIF procedure, the MAS® TLIF or Maximum Access Surgery (MAS) TLIF. Designed to be used with a minimally invasive spine surgery approach, TLX implants can be placed seamlessly into the disc space due to their low profile, bulleted design. A proprietary inserter allows the surgeon to insert, expand and rapidly post pack the implant through the same instrument, optimizing surgical efficiency. The TLX interbody system provides restoration of sagittal alignment with customizable degrees of lordosis and was designed to induce lordosis in an anatomical fashion, unique to what is currently on the market.

Prior to the expanded 510(k) clearance, TLX interbodies were available in 15 degree lordotic options and were only indicated for use with allograft. The recent clearance includes a 20 degree expandable interbody, and additional indications for use with allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The new indications also include use in the thoracic spine and at the thoracolumbar junction for treatment of disc degeneration disease or degenerative spondylolisthesis at one or two adjacent levels. Use of the TLX interbody system as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis was also cleared. The TLX system’s size offerings provide multiple options for varying patient size and anatomic considerations.

“With the additional clearance for our latest TLX system, we now provide the leading tools for TLIF procedures with our MAS TLIF solution, validating our commitment to improving spine solutions,” said Matt Link, executive vice president of strategy, technology and corporate development of NuVasive. “This clearance highlights our persistant investment in transforming spine outcomes by developing spine’s leading procedures, materials, expandables, systems and services.”

The TLX interbody system, coupled with the Company’s Integrated Global Alignment® (iGA) suite of software that allows surgeons to calculate, correct and confirm a patient’s pathology, has the ability to improve TLIF procedures overall. The software can calculate alignment parameters with the preoperative planning tools NuvaLine® and NuvaMap® and can intraoperatively correct using real-time intraoperative assessment with NuvaMap O.R. software. Surgeons can then confirm the restoration and preservation of global sagittal alignment postoperatively.

“The procedurally-integrated TLIF platform from NuVasive has allowed me to become much more efficient in my TLIF procedures,” said William Hunter, MD, neurosurgeon at The Spine Clinic at Neuroscience and Spine Center of the Carolinas. “The platform also allows me to confirm restoration of my patients’ lordosis intra-operatively using NuvaMap O.R. These tools have made my procedures more predictable, providing optimal treatment for my patients.”

NuVasive will showcase its market-leading, procedurally-integrated technologies, including the new TLX interbody system in NuVasive Booth #713 at the North American Spine Society Annual Meeting held October 25-28, 2017 in Orlando, Fla.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is transforming spine surgery and beyond with minimally invasive, 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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Stryker Receives FDA Clearance for Cementless Mako Total Knee with Triathlon® Tritanium®

Posted On October 16, 2017 By OrthoSpineNews In Recon, Regulatory, Robotics, Top Stories /  

MAHWAH, N.J., Oct. 16, 2017 /PRNewswire/ — Stryker’s Joint Replacement division today announced that its cementless Mako Total Knee with Triathlon Tritanium has received 510(k) market clearance by the U.S. Food and Drug Administration.

Triathlon Tritanium combines the kinematics of Stryker’s market leading Triathlon knee implant with the latest in highly porous biologic fixation technology for a knee system like no other.  The innovation of Tritanium’s tibial baseplate and metal-backed patella components are enabled by Stryker’s proprietary AMagine additive manufacturing technology and are SOMA-designed.

With cementless procedures rising in popularity and becoming a fast-growing trend1, Mako Total Knee with Triathlon Tritanium expands the current robotics offering to provide a cementless solution for orthopaedic surgeons seeking a more predictable surgical experience combined with increased operating room efficiency, biologic fixation and an alternative to bone cement.

“With the rise in demand for cementless knee technology, we believe this new offering can have a positive impact on procedural efficiency and patient outcomes,” said Stuart Simpson, President, Stryker’s Joint Replacement division.  “We’re excited to continue to lead in robotic technology and combine two of our most advanced and differentiated products to provide surgeons with the ability to transform orthopaedic surgery.”

About Stryker
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.

References:

1.

Table 54: Primary TKA Implant Market. US Markets for Large-Joint Reconstructive Implants 2013. Millennium Research Group. March 2013. Pg. 84

 

SOURCE Stryker

Related Links

http://www.stryker.com

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Cervical Posterior: Smart Solutions for Complex Surgeries

Posted On October 16, 2017 By OrthoSpineNews In Spine /  

With an estimated market value of $350M, posterior cervical fusion is still an attractive growing market. Common indications for Posterior cervical fixation are pain caused by excessive motion, sagittal balance correction and instability from a traumatic event. Cervical posterior systems are often described as smaller lumbar versions, grossly discounting the often unpredictable challenges of the cervical anatomy.

A comprehensive implant range is your best bet to overcome unforeseen intraoperative struggles. For example, the C7 vertebra is often skipped due to its location, yet a very low profile screw head with extreme angulation can overcome the challenge. Crosslinks fixed to screw heads help avoid spinal cord compression while transition rods and a wide variety of domino connectors allow effortless constructs.

When the Perla® system was designed, focus was placed on creating an extensive implant range, combined with a single compact instrument set. Dr Vittorio Morreale, Henry Ford Hospital (MI), has described Perla® as ‘truly efficient and complete’. In conjunction with surgical power for screw insertion, Perla® has become his system of choice for posterior cervical fixation. “I prefer inserting the screws with the aid of a power tool. I have observed over the years increasing reproducibility, control and precision that I couldn’t quite achieve with manual placing.”

For additional information on Perla, click here.

Discover the advantages of partnering with Spineart

 

Spineart will be at NASS, booth #316.

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Spine Surgeons in Texas and Indiana Advance Patient Care with Structurally Encoded Devices

Posted On October 13, 2017 By OrthoSpineNews In Spine, Top Stories /  

SAN ANTONIO, TEXAS (PRWEB) OCTOBER 13, 2017

Zeshan Hyder, DO, of Bone & Joint Specialists in Merrillville, Ind.; Frank K. Kuwamura, III, MD, of Innovative Spine in San Antonio, Texas; and Larry M. Kjeldgaard, DO, of Cervical Spine Specialist in Fort Worth, Texas are the first surgeons to implant medical devices from Nvision Biomedical Technologies with Structural Encoding® technology. The Structural Encoding technology advances patient care by providing permanent marking embedded within the device that is accessible through an x-ray image.

“We are always looking for the best technologies available to improve the results for our patients and get them back to their productive and pain-free activity as quickly as possible. Having a clear knowledge of their history helps us create the best plan of care. Structural encoding provides transparency for surgeons and patients that creates a new level of knowledge from patient research to implant integrity, all of which equals better patient care,” said Dr. Hyder.

Dr. Kuwamura agrees, “As surgeons, we take care to understand our patients’ lifestyles and activity level. The more knowledge we have, the better decisions we can make for their care. Patients move, physicians retire, and when we see patients that have had previous procedures with other surgeons, it can be almost impossible to get their records. We spend significant time trying to track that information down, but sometimes we don’t know what has previously been implanted until we are in surgery. Structural Encoding changes all of that. We now have a way to know everything about a device and previous surgeries simply by taking an x-ray.”

Structural Encoding, a patented technology platform developed by Watershed Idea Foundry, is the industry’s most innovative solution for medical device identification with permanent direct part marking. Manufacturers can license the technology for use in their medical devices to meet the U.S. Food and Drug Administration’s (FDA) regulation around permanent marking of the device itself, called Unique Device Identification (UDI). Nvision Biomedical Technologies, a San Antonio-based medical device and biologics manufacturer, is the first company to launch devices with the Structural Encoding technology.

“We work with our patients to determine the best outcomes for getting them back to their quality of life and sometimes that means surgery,” said Dr. Kjeldgaard. “If we do determine surgery is the best course of action, the knowledge we have and the more information we can provide our patients, the better. Structural Encoding gives us an advantage in patient care and gives the patient peace of mind for a lifetime.”

Nvision initially launched three devices in the nv line with Structural Encoding. nv(c)® is an anterior cervical interbody fusion system; nv(p)® is a posterior lumbar interbody fusion system; and nv(a)® is an anterior lumbar interbody fusion system. The initial surgeries were anterior cervical discectomy with fusion at one and two levels, with a structurally encoded nv(c) PEEK interbody implant.

“The entire medical device industry is looking to provide UDI compliant devices, but none are as seamless or as user-friendly as those with Structural Encoding,” said Dr. Hyder. “Structural Encoding is self-contained and doesn’t cause any extra steps or paperwork for the surgeon or the hospital, and that alone is good for our patients.”

About Nvision Biomedical Technologies 
Nvision is a San Antonio-based medical device and biologics manufacturing company focused on providing surgeons implants that are paired with instrumentation and biologics to simplify and improve surgery procedures that help patients get back to their quality of life.

Nvision is committed to developing and manufacturing thoughtfully designed products combined with exceptional service that keep the patients, surgeons, healthcare providers and distribution partners in mind. Nvision is aligned with surgeon thought leaders, key researchers, and development engineers from prestigious institutions to design, test, and bring to market the most innovative concepts.

About Dr. Zeshan Hyder 
Dr. Zeshan Hyder is partner with Bone & Joint Specialists in Merrillville, Ind. He is a board-certified orthopedic surgeon, who has been voted Best of the Region for Spine Care by The Times for three straight years.

He graduated Cum Laude from the University of Illinois and throughout his medical education has published articles on various subjects related to arthroplasty and spinal surgery. During his fellowship and residency programs he gained valuable expertise in sports medicine, orthopedics and trauma as well as conservative and surgical management of all orthopedic spinal disorders.

About Dr. Frank Kuwamura 
Dr. Frank K. Kuwamura, the founder and chief surgeon at Innovative Spine in San Antonio, Texas, is a board-certified orthopedic surgeon who specializes in emerging technology for spinal care.

A graduate of Boston University Medical School, Kuwamura completed his internship in general surgery and residency in orthopedic surgery at the National Naval Medical Center in Bethesda, Maryland where he earned the rank of Commander in the 3rd Marine Division. He is a member of the American Academy of Orthopedic Surgeons and the Bexar County Medical Society. He has held the title of Diplomat of the National Board of Medical Examiners and served on the American Board of Orthopedic Surgeons, Board Certification.

About Dr. Larry Kjeldgaard
Dr. Larry M. Kjeldgaard, founder and owner of Cervical Spine Center in Fort Worth and Hurst, Texas is a board-certified orthopedic surgeon who specializes in the treatment of the spine, neck and back.

A graduate from the Philadelphia College of Osteopathic Medicine, Dr. Kjeldgaard completed his residency at the Community General Osteopathic Hospital in Harrisburg, PA, and his orthopedic surgery residency training in Pontiac, Michigan. He’s a member of American Osteopathic Board of Orthopedic Surgeons, American Medical Association, the American Osteopathic Academy of Orthopedics and Texas Osteopathic Medical Association.

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DePuy Synthes EMEA Showcases Minimally Invasive Spine System Designed To Improve Intraoperative Efficiencies

Posted On October 13, 2017 By OrthoSpineNews In Spine, Top Stories /  

Dublin, Ireland – 11 October 2017 –Today, DePuy Synthes, part of the Johnson & Johnson Family of Companies, unveiled the VIPER PRIME™ System, an innovative Minimally Invasive Surgery (MIS) pedicle screw designed to simplify MIS spinal fusion surgery. VIPER PRIME reduces the number of instruments needed, the number of instrument passes and the number of steps required to insert a percutaneous screw utilizing a minimally invasive technique. The product was shown for the first time during this week’s EUROSPINE 2017 congress taking place in Dublin, Ireland.

Minimally invasive spinal fusion surgery is gaining popularity thanks to evidence that it may help improve outcomes when performing surgery through a smaller skin incision, which leads to less trauma to surrounding soft tissue, reduced blood loss during operation, and potentially a faster recovery for patients(3,4). However, as MIS fusion becomes more common, there is a need to simplify these procedures and overcome clinical challenges associated with the current technology.

By combining all the pedicle preparation instruments into one single tool, the VIPER PRIME System eliminates the need for guidewires, Jamshidi needles and additional pedicle preparation instruments. In one bench study, the VIPER PRIME System demonstrated a 33 percent reduction in the time required to insert a pedicle screw compared to traditional MIS techniques(2).

“I find the VIPER PRIME System easy and straightforward and I look forward to using it again for my future spinal fusion cases,” said Dr Kavakebi, an early user of the system from University Hospital Innsbruck, Austria.

Dr. Bordon from Hospital Manises, Valencia, Spain, who conducted the first surgery with the system in Europe concludes, “My OR team were very positive about the ease of assembly and the low footprint of the new system, that led to a more organized operating room.”

The VIPER PRIME System requires only two instrument trays, which may result in a more organized back table with fewer instruments, enhancing surgical workflow. The streamlined instrument set means a smaller procedural footprint that can also help reduce waste and processing costs.

“As a leader in pedicle screw technology, we have a responsibility to continue to innovate ways to make spinal fusion surgery less invasive for patients and less complicated for surgeons,” said Nadav Tomer, Global Platform Leader, DePuy Synthes Spine.

“The VIPER® System has more than ten years of clinical heritage and this introduction of VIPER PRIME is our latest example of how we are providing differentiated technologies that simplify spine surgery, making it more reproducible for every surgeon while improving patient outcomes,” concluded Jordy Winters, DePuy Synthes Spine EMEA Lead.

About DePuy Synthes Companies
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com .

Notes to editors
The VIPER PRIME System is currently being introduced to health care professionals in the Europe, Middle East and Africa (EMEA) region during educational and industry events. Full EMEA commercial availability of this tool is expected in early 2018.

The third-party trademarks used herein are the trademarks of their respective owners.

©Johnson & Johnson Medical Limited. 2017. All rights reserved.

Registered Office: Johnson & Johnson Medical Limited, PO BOX 1988, Simpson Parkway, Livingston, West Lothian, EH54 0AB, United Kingdom. Incorporated and registered in Scotland under company number SC132162

References

  1. VIPER PRIMETM System Overview – DSEM/SPN/0617/0698
  2. Internal data on file: ADAPTIV test report 103327910. Note: Bench tests results may not necessarily be indicative of clinical performance.
  3. Jhala, Amit, et al. Minimally invasive transforaminal lumbar interbody fusion. Indian Journal of Orthopaedics 48(6) (2014 Nov-Dec); 562-567
  4. Peng, Chan Weam Benedict, et al. Clinical and Radiological Outcomes of Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion. SPINE Vol. 34, Number 13 (2009); 1385-1389.

DSEM/SPN/1017/0761

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