Dr. Richard Rothman Recognized As 100 Great Health Care Leaders To Know In 2017

Richard H. Rothman, MD, Ph.D, Founder, Rothman Institute and Professor of Orthopaedic Surgery at Sidney Kimmel Medical College at Thomas Jefferson University, was named one of the 100 Great Health Care Leaders to Know in 2017, by Becker’s Hospital Review. The list was comprised of, “100 exemplary leaders of health care providers, government agencies, insurers and companies with successful track records leading their organizations.” Other notable leaders appearing on the list include: President of the Joint Commission, Director of the National Institutes of Health, Director of the World Health Organization, and the Secretary of Health and Human Services.

“It is an honor to be recognized by such a well-known medical publication,” said Dr. Rothman. “This list includes some of the best and brightest minds in medicine today. To be included with such select company is truly humbling.”

“Dr. Rothman is not just a leader, but a visionary in the world of orthopaedic medicine,” said Alexander R. Vaccaro, MD, Ph.D, MBA, President, Rothman Institute, Richard H. Rothman Professor and Chairman, Department of Orthopaedic Surgery, at Sidney Kimmel Medical College at Thomas Jefferson University. “He is a master clinician, a passionate educator, a dedicated researcher and a selfless philanthropist. He embodies all of the qualities a medical leader needs in this day and age. On behalf of all Rothman Institute we congratulate him on a recognition well deserved.”

 

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Smith & Nephew signs exclusive worldwide distribution agreement for the revolutionary MolecuLight i:XTM imaging device

3 May 2017

Smith & Nephew plc (LSE:SN, NYSE:SNN), the global medical technology business, today announces it has signed a worldwide distribution agreement with MolecuLight®, Inc., a developer of innovative imaging technology for the clinical assessment of wounds.

This agreement supports Smith & Nephew’s strategic priority to innovate for value by delivering solutions that help healthcare professionals better improve the lives of their patients.

“Smith & Nephew, through products such as ACTICOAT antimicrobial silver dressings and IODOSORB cadexomer gel ,has long been committed to helping customers manage infection in chronic and acute wounds,” said Andy Weymann, MD, Chief Medical Officer at Smith & Nephew.  “The MolecuLight i:X imaging device enables healthcare professionals to see what they have never been able to see before, the actual accumulation of several common bacteria in a wound, even when not visible to the naked eye.  Moleculight  i:X enhances clinicians’ ability to choose the right therapy, at the right time for their patient 1,2 In addition, it has also the potential to enhance other areas of current wound care practice such as helping to guide wound sampling and debridement, monitoring of  wound progression, providing more insight in conversation between the clinician and the patient, and greater detail when documenting treatment decisions.”

Rosemary Hill, BSN, CWOCN, CETN(C), of Lions Gate Hospital (Vancouver, Canada) added ‘’The MolecuLight i:X is more than a bacteria visualization device. The information it is providing is positively impacting our antimicrobial stewardship program and empowering my overall wound treatment decision making.’’

The MolecuLight i:X  is a handheld point-of-care imaging device that uses fluorescence imaging to display potentially harmful concentrations of bacteria that fluoresce in violet light on screen, in real-time.  Clinicians can capture and view still images and video, as well as measure the surface area of a wound and then save and add those images to the patient’s electronic health record 2,3.

“When combined with clinical best practice, the information provided by the MolecuLight i:X on bacterial presence and distribution can guide early interventions to potentially reduce bioburden and promote wound healing2,” said Craig Kennedy, CEO MolecuLight.  “Partnering with Smith & Nephew, a world leader in advanced wound care, allows this revolutionary technology to rapidly reach a worldwide customer base and begin the process of becoming a routine step in wound assessment.”

The MolecuLight i:X is currently available in Canada and the European Union with regulatory clearance in the U.S. pending.

Enquiries

Media
Dave Snyder +1 (978) 749-1440
Kirsti Harefallet +44 (771) 008 5253
Smith & Nephew

 

About MolecuLight Inc. 

MolecuLight Inc. is a privately owned, Canadian medical imaging company delivering real-time fluorescence image-guidance solutions that provide clinicians with new information about wound bacterial burden and wound surface area to assist clinicians in making improved diagnostic and treatment decisions1,2,4,5,6,7,8,9,10.  The company was founded in 2012 by Dr. Ralph DaCosta, Principal Investigator and Scientist at the Princess Margaret Cancer Center, University Health Network (Toronto, Canada), currently the company’s Chief Scientific Officer and Director. MolecuLight’s premiere product – the MolecuLight i:X is a Wound imaging Device that allows clinicians to quickly, safely and easily visualize  bacteria that fluoresce in violet light and measure wound surface area at the point of care so they have maximum insights for accurate treatment and accelerated healing 2.

The MolecuLight i:X™ Imaging Device is approved by Health Canada (Medical License #95784) and has CE Marking (Certificate # G1160292355002) for sale in the European Union. The MolecuLight i:X™ Imaging Device is pending US FDA De Novo approval and is not available in the US.

About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2015 were more than $4.6 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE:SNN).

For more information about Smith & Nephew, please visit our website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.

To learn more about what we do to help reduce wound infections, please visit www.closertozero.com.

Forward-looking Statements

This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.

Trademark of Smith & Nephew.  Certain marks registered US Patent and Trademark Office.

 References:

  1. Wu YC, Smith M, Chu A, Lindvere-Teene L, Starr D, Tapang K, Wong O, Linden R, DaCosta RS. Handheld fluorescence imaging device detects subclinical wound infection in an asymptomatic patient with chronic diabetic foot ulcer: a case report. Int Wound J. 2016 Aug;13(4):449-53.
  2. DaCosta RS, Kulbatski I, Lindvere-Teene L, Starr D, Blackmore K, Silver JI, Opoku J, Wu YC, Medeiros PJ, Xu W, et al. Point-of-care autofluorescence imaging for real-time sampling and treatment guidance of bioburden in chronic wounds: first-in-human results. PLoS One. 2015 Mar 19;10(3).
  3. Hill R and Douglas JJ. Effect of bacterial fluorescence imaging on patient care and wound management in a hospital setting: a pilot study. Proceedings of the Annual Symposium on Advanced Wound Care (SAWC); 2017 Apr 5-9; San Diego, CA. (accepted poster)
  4. Ottolino-Perry K, Chamma E, Blackmore KM, Lindvere-Teene L, Starr D, Tapang K, Rosen CF, Pitcher B, Panzarella T, Linden R, DaCosta RS. Improved detection of clinically relevant wound bacteria using autofluorescence image-guided sampling in diabetic foot ulcers. Int Wound J. 2017; doi: 10.1111/iwj.12717.
  5. MolecuLight Inc. Case Study 0051 Track Wound Size and Bacterial Presence with the MolecuLight i:X. 2016.
  6. Rennie MY. A prospective, single-blind evaluation of the positive predictive value (PPV) of the MolecuLight i:X device to predict the presence of porphyrin-producing bacteria in chronic wounds. MolecuLight final report TR054. 2017 Jan.
  7. MolecuLight Inc. Case Study 0051 Track Wound Size and Bacterial Presence with the MolecuLight i:X. 2016.
  8. Raizman R. Point-of-care fluorescence imaging device guides care and patient education in obese patients with surgical site infections. Presented at: CAWC 2016. Proceedings of the 22nd Annual Canadian Association of Wound Care Conference; 2016 Nov 3-6, Niagara Falls, ON.
  9. Raizman R. Fluorescence imaging positively predicts bacterial presence and guides wound cleaning and patient education in a series of pilonidal sinus patients. Proceedings of the Annual Wounds UK Conference; 2016 Nov 14-16; Harrogate, UK.
  10. Hoeflok J, Teene L, Chamma E, Chu A, DaCosta RS. Pilot clinical evaluation of surgical site infections with a novel handheld fluorescence imaging device. Proceedings of the Annual Military Health System Research Symposium (MHSRS); 2014 Aug 18-21; Fort Lauderdale, FL.  

Global Knee Replacement Devices Market to Grow at a CAGR of 3.25% by 2021: Growing Demand for Cementless Knee Replacement – Research and Markets

DUBLIN, May. 03, 2017 /PRNewswire/ —

Research and Markets has announced the addition of the “Global Knee Replacement Devices Market 2017-2021” report to their offering.

The global Knee Replacement Devices market to grow at a CAGR of 3.25% during the period 2017-2021.

The report, Global Knee Replacement Devices Market 2017-2021, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the market landscape and its growth prospects over the coming years. The report also includes a discussion of the key vendors operating in this market.

The latest trend gaining momentum in the market is growing demand for cementless knee replacement. Globally, among all knee replacement procedures, the majority of surgeons use cemented knee replacements devices. However, these cemented knee replacement devices have many post-operative complications after they have been implanted in the body.

According to the report, one of the major drivers for this market is high prevalence of knee-related issues. Knee-related disorders are some of the major global health issues, which affect most people above 40 years and are more specific for people aged above 60 years. Arthritis, trauma, back pain, and osteoporosis are the most common joint problems globally. Limited physical activity and unhealthy eating habits can negatively influence the body’s homeostasis.

Key vendors

  • Zimmer Biomet
  • DePuy Synthes
  • Stryker
  • Smith & Nephew
  • Exactech
  • ConforMis

Other prominent vendors

  • Aesculap Implant Systems
  • Arthrex
  • Arthrosurface
  • Baumer
  • Corentec
  • Others

Key Topics Covered:

PART 01: Executive summary

PART 02: Scope of the report

PART 03: Research Methodology

PART 04: Introduction

PART 05: Market landscape

PART 06: Market segmentation by procedure type

PART 07: Market segmentation by end-user

PART 08: Geographical segmentation

PART 09: Decision framework

PART 10: Drivers and challenges

PART 11: Market trends

PART 12: Vendor landscape

PART 13: Key vendor analysis

PART 14: Appendix

For more information about this report visit http://www.researchandmarkets.com/research/l9kldn/global_knee

Media Contact:

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com

For E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716

SOURCE Research and Markets

Related Links

http://www.researchandmarkets.com

NuVasive Announces Sponsorship Of EPOSNA 2017 And Launches New Monthly Pediatric Spinal Deformity Podcast

SAN DIEGO, May 2, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the Company is a leading sponsor of EPOSNA 2017, the combined meeting of the EPOS (European Paediatric Orthopaedic Society) and POSNA (Pediatric Orthopaedic Society of North America) annual meetings, held this week in Barcelona, Spain. NuVasive also announced the launch of a monthly podcast, MAGEC Matters, featuring interviews with the leading surgeons in pediatric deformity and sharing clinical insights on the treatment of early-onset scoliosis.

“At NuVasive, we are not only passionate about the world-class innovation we are bringing to market to help improve pediatric spinal deformity, but we’re also passionate about the education and research that is necessary to provide surgeons with the information they need to advance the care options available to pediatric patients,” said Jason Hannon, NuVasive’s president and chief operating officer. “We’ve made tremendous investments in building a comprehensive pediatric deformity portfolio, with our MAGEC® system, RELINE®posterior fixation platform and PRECICE® limb lengthening system. By supporting events such as EPOSNA, we are able to connect surgeons from around the world and help improve the lives of children.”

EPOSNA is the world’s largest pediatric orthopaedic scientific meeting with over 1,300 abstracts submitted. The Company’s sponsorship of the event includes exhibit floor presence featuring pediatric spine and orthopedic solutions and the following workshops:

  • “MAGEC Masters Roundtable: Key Principles for Challenging Applications”; Wednesday, May 3, 2017 from 12:45 – 13:35 p.m. (CEST); Featuring Michael Vitale, M.D., Peter Sturm, M.D., Burt Yaszay, M.D. and Jeff Sawyer, M.D.
  • “So You’re Not Sure You Can Do Limb Lengthening”; Thursday, May 4, 2017 from 12:45 – 13:35 p.m. (CEST); Featuring Christof Radler, M.D. and Frank Schiedel, M.D.

As a key education initiative for the pediatric spinal deformity community, NuVasive also announced the launch of a monthly podcast series, MAGEC Matters, featuring interviews with leading surgeons in pediatric deformity discussing tips for the treatment of early-onset scoliosis, which is now available on iTunes, SoundCloud and other leading podcast platforms.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries around the world. 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

Twenty-one Physicians Charged in Kickback Scheme

 – April 27, 2017

A southern California practice management company called Monarch Medical Group used to advertise that it could provide physicians with new revenue streams from transdermal pain creams, oral medication dispensing, and urine drug-screening tests.

Those revenue streams could lead to prison for 21 physicians charged in a California state court last week with fraudulently billing workers’ compensation insurers for these ancillary services and accepting kickbacks for patient referrals. It was all part of a scheme allegedly masterminded by Tanya King and her husband, Christopher King, owners of Monarch Medical Group and related companies, according to state prosecutors and the California Department of Insurance (CDI).

The Kings also were charged in the case, as were two pharmacists who owned a pharmacy and a physician assistant.

“The Kings and their co-conspirators played with patients’ lives, buying and selling them for profit without regard to patient safety,” said CDI Commissioner Dave Jones in a news release.

From 2011 to 2015, the operation fraudulently billed insurers for $40 million and collected more than $23 million for services rendered to some 13,000 patients. The 21 physicians netted almost $2.2 million in kickbacks, which were labelled as marketing expenses to make them look legitimate, prosecutors said. The average age of the physicians was 57.

Buy for $40, Bill for $700

The scams alleged by prosecutors were based on the three ancillary services that Monarch Medical Group advertised on its website.

 

READ THE REST HERE

Surgeons Perform World’s First-Ever Dual Robotic Surgery at Jerusalem’s Hadassah Hospital

NEW YORK, April 28, 2017 /PRNewswire-USNewswire/ — The world’s first-of-its-kind dual robotic surgery was performed on April 23 at Hadassah Hospital Ein Kerem in Jerusalem, announced  National President Ellen Hershkin of Hadassah, the Women’s Zionist Organization of America, Inc. (HWZOA).

The revolutionary dual robotic surgery assisted in the repair of a severe spinal fracture suffered by Aharon Schwartz, 42, a factory worker in Jerusalem who was injured when a steel object pinned him to the ground, fracturing his leg in two places and breaking six of his spinal vertebrae.  The 3-hour surgery took place in the state-of-the-art $30M underground hybrid operating theater at Hadassah’s Sarah Wetsman Davidson Hospital Tower.

Dr. Meir Liebergall, Chairman of the Hadassah Medical Organization’s (HMO) Orthopedic Department and head of HMO’s Musculo-Skeletal Medicine Division, explained the pioneering surgery.  “Two robots, Siemens’ Artis Zeego and the Mazor Robotics’ Renaissance® Guidance System, were involved in the surgery.  Artis Zeego, overseen by Dr. Amal Khouri, Director of HMO’s Orthopedic Hospitalization Center, provided real-time 3-dimensional imaging during the surgical procedure, which eliminated the need for pre-surgery CT scans and post-surgery X-rays. Renaissance® Guidance System, a screw placement system which allows spinal implant placement with maximum safety and accuracy, was controlled by HMO Sr. Orthopedic Surgeon Dr. Josh Schroeder. Renaissance communicated with Artis Zeego during the minimally-invasive surgery while Dr. Schroeder led the Hadassah orthopedic team in the insertion of eleven pedicle screws into the patient’s spine with clinical exactitude.”

Dr. Liebergall predicted that patient Schwartz will completely recover from the surgery and will be walking again very shortly.

Hershkin states, “Once again, HMO achieves another world-first – a dual robot-assisted spinal surgery, solidifying its reputation for world class medical innovation and treatment.  Our congratulations go to Dr. Liebergall and his brilliant surgical team for continuing Hadassah’s mission of bringing ground-breaking medical care to the people of Israel.”

The Mazor Robotics Renaissance® Guidance System transforms spine surgery from freehand procedures to highly-accurate, state-of-the-art procedures that may reduce fluoroscopy—even for minimally-invasive surgery (MIS), scoliosis, and other complex spinal deformity cases.

The Siemens Artis Zeego® Robotic Technology enables smoother, swifter and trouble-free patient positioning and execution procedures.

Hadassah, the Women’s Zionist Organization of America, Inc. (HWZOA) is the largest Jewish women’s organization in the United States. With 330,000 members, associates and supporters Hadassah brings Jewish women together to effect change and advocate on critical issues such as medical care and research and women’s empowerment. Through the Hadassah Medical Organization’s two hospitals, the world-renowned trauma center and the leading research facility in Jerusalem, Hadassah supports the delivery of exemplary patient care to over a million people every year. HMO serves without regard to race, religion or nationality and earned a Nobel Peace Prize Nomination in 2005 for building “bridges to peace” through equality in medical treatment. For more information, visit www.hadassah.org.

SOURCE Hadassah, The Women’s Zionist Organization of America, Inc. (HWZOA)

Related Links

http://www.hadassah.org

Life Spine® Achieves Considerable Sales Growth of ProLift® Expandable Spacer System, Doubling Sales Quarter over Quarter

May 02, 2017

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today continued growth of their micro invasive expandable interbody, ProLift. “With the introduction of ProLift to the market in Q2 of 2016, we have since consistently doubled our sales growth quarter over quarter,” said Mariusz Knap, Vice President of Marketing for Life Spine. “We are excited about the adoption of ProLift, and will continue to focus on technological advancements that strive to improve surgical efficiencies and outcomes through procedural based and micro invasive expandable solutions. Products such as ProLift are the core competencies which we will continue to drive for our procedural based product portfolios.”

ProLift, a titanium expandable posterior interbody solution allows for in-situ expansion for restoration of normal anatomic disc height and decompression of neural elements. ProLift, used in conjunction with CALYPSORetractor and CENTERLINE® Cortical Bone Screws, provides the surgeon minimal tissue disruption while achieving surgical goals.

Zeshan Hyder, D.O., of Bone and Joint Specialists of Northwest Indiana notes,“The continued evolution of MIS surgery to reduce tissue morbidity and restore anatomical alignment, especially in severe degenerative and collapsed disc, is being achieved in my practice with the expandable technologies such as ProLift, and the lateral system LONGBOW®. Both of these systems reduce the requirements for multiple instrument passes by important neural structures while maintaining my surgical goals and positive patient outcomes.”

ProLift continues Life Spine’s commitment of offering innovative micro invasive procedural solutions to better improve patients’ lives. In addition, Life Spine launched its new website highlighting their complete core and micro invasive procedural solutions. The website is a staple to the new look of Life Spine, and helps surgeons access information about advancements in surgical innovations.

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.

Contacts

Life Spine
Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

SI-BONE – SI Joint Fusion Study Showed Patients Were 11X Less Likely to be Taking Opioids at Last Follow-Up Using the iFuse Implant™

SAN JOSE, Calif., May 1, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced results from two recently published comparative studies showed patients treated with the iFuse ImplantTM were significantly less likely to be taking opioid medications than patients treated with non-surgical care.  The most recently published paper titled Minimally Invasive Sacroiliac Joint Fusion, Radiofrequency Denervation and Conservative Management for Sacroiliac Joint Pain: Six Year Comparative Study,1 published in the journal Neurosurgery, showed that patients treated with iFuse were 11X less likely to be taking opioids at last follow-up than those who were denied coverage for iFuse and treated with either conservative care or radiofrequency ablation (>80% vs, 7%) (Figure 1, below).

“Given the catastrophic opioid addiction epidemic we are currently dealing with in this country today, any procedure, device or technology that demonstrates the ability to significantly reduce opioid use should be made available to anyone who can benefit,” said Frank Guinta, former New Hampshire congressman and co-founder of the Congressional Bipartisan Committee on opioid and heroin addiction. “Given the overwhelming amount of high quality level 1 clinical evidence associated with the iFuse Implant, it seems prudent and obvious to me that anyone properly diagnosed as an appropriate surgical candidate should have access to the procedure.”

A second publication of two-year results from INSITE,2 a randomized controlled trial of MIS SI joint fusion with the iFuse Implant compared to non-surgical management, showed a 30% decrease from baseline in the number of subjects taking opioids at two years compared to patients treated non-surgically (Figure 2, below).

“It’s rather remarkable that in both studies the number of patients taking opioids in the iFuse Implant group was significantly lower than the number of patients taking opioids in the non-surgical care group in spite of a lack of a structured program focused on opioid use dependence,” said Daniel Cher, MD, Vice President of Clinical Affairs at SI-BONE.  “It’s clear from the evidence in these two studies that treatment with the iFuse Implant was associated with a reduction in opioid use in patients with chronic SI joint pain who were taking opioids and who no longer responded to non-surgical care.”

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading innovative medical device company dedicated to the development, manufacture and commercialization of minimally invasive surgical devices for the treatment of patients with low back symptoms related to certain sacroiliac (SI) joint disorders.  SI-BONE, Inc. first received 510(k) clearance to market its iFuse Implant System (“iFuse”) from the Food and Drug Administration (FDA) in November 2008. The CE mark for European commercialization was obtained in November 2010.

The iFuse Implant System provides a minimally invasive surgical solution to fuse the SI joint using patented triangular titanium implants that create an interference fit within the ilium and sacrum.  The triangular implant shape, combined with the press fit insertion, is designed to provide immediate fixation by minimizing rotational motion.  The implants have a porous surface that provide an ideal environment for bone on-growth and ingrowth*, facilitating long-term fusion of the joint.  iFuse is the only commercially available SI joint fusion device in the United States with published prospective clinical evidence that demonstrates safety, effectiveness and economic benefits, including three large multicenter studies, two of which are randomized controlled trials.  Currently, there are more than 50 peer-reviewed publications supporting positive clinical outcomes, safety, biomechanics, and the economic value of iFuse (www.si-bone.com/results).  iFuse Implant is the only SI joint fusion device with a FDA clearance recognizing demonstrated improvements in pain, patient function and quality of life following treatment.

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

* MacBarb RF, Lindsey DP, Woods SA, Lalor PA, Gundanna MI, Yerby SA. Fortifying the Bone-Implant Interface Part II: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants. Int J Spine Surg. 2017;11. [Accepted, publication pending]

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved. 9875.050117

1

Vanaclocha V, Herrera JM, Sáiz-Sapena N, Rivera-Paz M, Verdú-López F. Minimally Invasive Sacroiliac Joint Fusion, Radiofrequency Denervation and Conservative Management for Sacroiliac Joint Pain: Six Year Comparative Study. Neurosurgery. 2017 April 20. [Epub ahead of print]. doi: 10.1093/neuros/nyx185.

2

Polly DW, Swofford J, Whang PG, Frank CJ, Glaser JA, Limoni RP, Cher DJ, Wine KD, Sembrano JN, and the INSITE Study Group. Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction. Int J Spine Surg. 2016;10.Article 28. doi:10.14444/3028.

 

SOURCE SI-BONE, Inc.

Related Links

http://www.si-bone.com

OrthAlign, Inc. Announces New Leadership Appointments to Drive and Support Corporate Growth Initiatives

OrthAlign, Inc., a privately held U.S.-based medical device and technology company providing orthopedic surgeons with advanced precision technologies, announced today the executive appointment of Mike Bushlack as Chief Financial Officer and the promotion of James Young Kim as Vice President and General Manager of International.

Mike Bushlack comes to OrthAlign with over 15 years of financial leadership experience in the medical device industry, working with early growth stage and large multi-national companies. Prior to joining OrthAlign, Mike was Chief Financial Officer of Blue Belt Technologies, Inc. and held executive financial leadership and business development roles at ev3 Inc., Covidien, and Medtronic, garnering a proven track record of partnering with business teams to develop and implement strategic plans and financial processes and focus investments to drive growth and enhance entity value. Mike began his career at KPMG LLP in Minneapolis, where he was a Senior Manager.

James Kim has over 12 years of strategic marketing and sales experience in the medical and healthcare industry, responsible for strategic planning, product and brand management, product development, and multiple launch and global commercialization assignments. Since October 2013, James served as OrthAlign’s Vice President of Sales and Marketing, helping lead the organization through an important growth period, including expansion of OrthAlign technology into key international markets. Prior to joining OrthAlign, James served in key marketing roles with Allergan, CareFusion, and Johnson & Johnson, successfully managing the Natrelle®, Pyxis®, and OneTouch® brands, respectively. James received an MBA from the University of Southern California’s Marshall School of Business.

“The executive appointments of Mike and James are key elements in our continued efforts to successfully expand our customer reach, portfolio of products, and focus in providing world class customer service to our surgeons, hospitals, and surgery centers across the globe,” said Eric B. Timko, OrthAlign’s Chief Executive Officer and Chairman. “We are energized and excited about the growth opportunities before us and are heavily focused on our strategic initiatives as one of the leading technology companies in orthopaedics.”

About OrthAlign, Inc.

OrthAlign is a privately held medical device and technology company, developing advanced technologies that deliver healthier and more pain-free lifestyles to joint replacement patients, globally. We provide healthcare professionals with cutting edge, computer-assisted surgical tools that seamlessly and cost-effectively deliver vital data and clinical results to optimize outcomes for our patients. For more information regarding OrthAlign, please visit http://www.orthalign.com.

“ORTHALIGN®, ORTHALIGN PLUS®, KNEEALIGN®, KNEEALIGN® 2, HIPALIGN®, and UNIALIGN™ are registered trademarks of OrthAlign, Inc.”

Medrobotics® Corporation Flex® Robotic System Receives Best New Product Award at 2017 Edison Awards

May 01, 2017

RAYNHAM, Mass.–(BUSINESS WIRE)–Medrobotics Corp., a medical products company, announced today that its Flex®Robotic System received a Best New Product Award at the 2017 Edison Awards™. The Company’s rich history of innovation was recognized with a Bronze Award in the Surgical Tools category.

The Edison Awards™ is an annual competition honoring excellence in new product and service development, marketing, human-centered design, and innovation. The competition is open to progressive organizations across the globe. Award winners represent “game changing” products and services, as well as excellence and leadership in innovation. This year, more than 3,000 companies submitted applications. The winners were chosen as the “best of the best” by a panel comprised of individuals selected from the world’s top senior business executives, academics, and innovation professionals.

“Medrobotics is pleased the Flex® Robotic System has received this new recognition for its unique capabilities,” said Samuel Straface, Ph.D., President and CEO of Medrobotics. “Our products overcome the limits of traditional line-of-sight surgical technologies. Surgeons are now able to access difficult to reach anatomy through a single, small entry point and treat patients who might otherwise have required an open surgical procedure.”

Medrobotics’ Flex® Robotic System was designed to provide an affordable, easy-to-use robot-assisted surgical platform for hospitals and surgeons seeking to provide minimally-invasive treatment options to the broadest number of patients. Minimally invasive surgery has demonstrated advantages for patients and providers, such as shorter hospital stays and faster recovery times.

About Medrobotics

Medrobotics Corporation (www.Medrobotics.com) is a privately funded medical device company headquartered in Raynham, Massachusetts. It manufactures and markets the Flex® Robotic System, the world’s first robotic surgical platform with a steerable and shapeable robotic scope. The Flex® Robotic System offers surgeons the unique ability to navigate complex anatomy through a single, small entry point and operate in hard-to-reach anatomical locations that might otherwise be inaccessible with straight, rigid surgical tools. The Company’s vision is to provide more patients with access to minimally invasive surgery. Medrobotics received FDA clearance for the Flex® Robotic System in July 2015, and the CE mark in March 2014.

Contacts

Medrobotics Corp.
Kevin Knight, 214-732-9392