News – Page 286 – Selby Spine

SINGAPORE, Oct. 14, 2016 /PRNewswire/ — Osteopore International is honoured with the 2016 Frost & Sullivan Singapore 3D Scaffolds Entrepreneurial Company of the Year Award in the Transformational Healthcare category.

This award is presented to Osteopore at the 2016 Frost & Sullivan Singapore Excellence Awards luncheon at the Conrad Centennial Singapore.

Ms. Vandana Iyer, Research Analyst at Frost & Sullivan said that Osteopore’s 3-D scaffold tissue engineering technology platform is uniquely poised above its competitors as it facilitates natural tissue healing and regenerative functions. “The technology comprises novel biomimetic and bioresorbable 3-D printed microstructure implants that can be efficiently used across neurological, craniofacial, maxillofacial, orthopaedic, spinal and dental applications. The company’s innovative 3D scaffold technology also has the potential to address the rising incidence of bone-related injuries and may transform the global bone graft market that is currently valued at around USD5 billion,” she added.

“Osteopore is proud to receive the 2016 Singapore 3D Scaffolds Entrepreneurial Company of the Year Award from Frost & Sullivan. The award is a testament to our vision and ability to transform healthcare with Singapore’s developed medical device technology,” said Mr. Goh Khoon Seng, Chief Executive Officer, Osteopore International.

“Our company has been harnessing 3D printing technology to design, develop and manufacture implantable devices that facilitate natural tissue regeneration, and has delivered successful clinical outcome over the past 10 years. This technology has the potential to minimise or eliminate late morbidity and re-surgery thus reducing cost for healthcare payers and patients,” he added.

The Frost & Sullivan Excellence Awards have identified and honoured best-in class companies that have demonstrated excellence in their respective industries. Award recipients were identified based on in-depth interviews, analysis, and extensive secondary research conducted by Frost & Sullivan’s analysts. Companies are typically studied on their revenues, market share, capabilities, and overall contribution to the industry in order to identify best practices.

For the Entrepreneurial Company of the Year Award, Frost & Sullivan analysts independently evaluated two key factors, Entrepreneurial Innovation and Customer Impact.

The Entrepreneurial Innovation criteria that were assessed include market disruption, competitive differentiation, market gaps, Blue Ocean Strategy and passionate persistence.

Customer Impact criteria include price/performance value, customer purchase experience, customer ownership experience, customer service experience and brand equity.

About Osteopore International

Osteopore International, based in Singapore, is the world leader in 3D printed biomimetic and bioresorbable implant devices that empowers the body to regenerate tissue. We collaborate with clinicians and researchers internationally to develop products that address unmet healthcare needs, reduce healthcare cost, improve patient outcomes and enhance lives. For more information, visit us at www.osteopore.com.

Contact : Goh Khoon Seng, (65) 9670-0812, goh_khoon_seng@osteopore.com

About Frost & Sullivan

Frost & Sullivan, the Growth Partnership Company, works in collaboration with clients to leverage visionary innovation that addresses the global challenges and related growth opportunities that will make or break today’s market participants. For more than 50 years, we have been developing growth strategies for the global 1000, emerging businesses, the public sector and the investment community. For more information, please visit www.frost.com

This content was issued through the press release distribution service at Newswire.com. For more info visit: http://www.newswire.com.

SOURCE Osteopore International Pte Ltd

Contacts

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

October 14, 2016

aap Implantate AG (“aap”) announces the market launch of its innovative periprosthetic LOQTEQ® system with the distal lateral femur plate 4.5 PP (periprosthetic). The system is based on a new patent pending fixation technology and enables the treatment of bone fractures in the immediate vicinity of joint implants already existing in the body. Thereby the periprosthetic LOQTEQ® system addresses one of the most demanding procedures in orthopaedics. The distal lateral femur plate 4.5 PP has a CE mark.

Implantations of artificial hip and knee joints are among the most frequent procedures in Germany. With such implantations bone fractures can occur in the immediate vicinity of the treated site during the life of the used joint implants. Treating such fractures poses a particular challenge in orthopaedics because the screws for the bone plates must be fixed around the joint implant. This is where aap’s periprosthetic LOQTEQ® system becomes effective with its innovative fixation technology.

The core of the new technology are special LOQTEQ® hinges that can be fixed to the plate both distally and proximally. They remain flexible within a 45° angle range and are anchored in the bone at a variable angle (±15°) by angle-stable 3.5 mm screws. In this way the fixation can be adapted for a wide range of bone diameters and the plates can be securely fixed past a prosthesis or a nail, especially in an osteoporotic bone. The hinges ensure that the surgeon has maximum flexibility in planning and carrying out the operational stabilisation by means of optional use at the proximal and distal end of the plate. aap’s offering in this area is complemented by cerclage trays for cable or wire cerclages.

In recent months the periprosthetic LOQTEQ® system has proven its worth in clinical initial applications in respect of user friendliness and flexibility. In the future, aap plans to extend the periprosthetic fixation technology to other relevant plates in the LOQTEQ® portfolio for different anatomical regions.

This release contains forward-looking statements based on current experience, estimates and projections of the management board and currently available information. They are not guarantees of future performance. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. Many factors could cause the actual results, performance or achievements of aap to be materially different from those that may be expressed or implied by such statements. These factors include those discussed in aap’s public reports. Forward-looking statements therefore speak only as of the date they are made. aap does not assume any obligation to update the forward-looking statements contained in this release or to conform them to future events or developments

For further information, please contact:

aap Implantate AG
Lorenzweg 5
12099 Berlin

Fabian Franke
Manager Investor Relations
Tel.: +49 (0)30 / 750 19 134
Fax: +49 (0)30 / 750 19 290
Contact

BEDFORD, Mass., October 17, 2016 (GLOBE NEWSWIRE) – ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that develops, manufactures and sells joint replacement implants that are customized to fit each patient’s unique anatomy, today announced that The Journal of Arthroplasty has accepted for printed publication, and published online, the results of an in vivo clinical study comparing the motion patterns of patients with a ConforMIS iTotal® CR implant versus patients with a traditional off-the-shelf total knee implant. The study demonstrated that ConforMIS iTotal CR patients exhibited motion patterns that were more consistent with the normal knee than the patients that had received traditional off-the-shelf implants.

“I have been using ConforMIS customized knee replacements for over five years and this study reinforces the results that I have observed in my patients that have received a ConforMIS iTotal CR implant,” said William Kurtz, MD, a fellowship-trained surgeon at Saint Thomas Midtown Hospital in Nashville, TN. “In my experience, the ConforMIS knee system typically gives my patients a better outcome than a standard off-the-shelf knee and a better opportunity to get back to doing the activities they love.”

In this study, researchers at the University of Tennessee’s Center for Musculoskeletal Research assessed the kinematics of 38 patients (24 patients with a ConforMIS iTotal CR implant and 14 patients with a leading off-the-shelf implant) all implanted by the same surgeon. Using state-of-the-art mobile fluoroscopy, researchers were able to analyze tibiofemoral kinematics, or motion patterns of the knee, and to evaluate each patient for weight-bearing range-of-motion, femorotibial translation, femorotibial axial rotation, and condylar liftoff during a weight bearing deep knee bend and a rise from a seated position.

When a healthy knee bends, the lateral condyle, or outer portion of the end of the thigh bone (femur), rolls back on the shin bone (tibia) and rotates externally towards the outside of the knee. Patients who received a ConforMIS iTotal CR demonstrated greater lateral femoral rollback (4.0mm vs. 1.2mm) and better axial rotation (6.3° vs. 4.4°) during deep knee bend, which is closer to normal knee motion. These differences were statistically significant.

During a deep knee bend, 35% of patients with the off-the-shelf knee replacement experienced implant lift-off in early flexion (prior to 60°), while none (0%) of the patients with iTotal CR experienced implant lift-off in early flexion. According to the researchers, this demonstrates that the iTotal CR had improved mid-flexion stability compared to the standard off-the-shelf implant. The researchers hypothesized that one reason iTotal CR patients exhibited less lift-off could be because the customized nature of the iTotal CR implant’s shape facilitates improved translation and rotation properties when compared to the traditional off-the-shelf implant, leading to a higher likelihood of a stable knee in mid-flexion. ConforMIS provided financial support for this study.

“This study is one of many examples of how ConforMIS challenges conventional wisdom in joint replacement and is leading the way in how patient outcomes are measured,” said Philipp Lang, MD, MBA, Chief Executive Officer and President of ConforMIS. “As a company, we are continuing to support head-to-head, direct comparative studies against many implant designs, and we are supporting multiple studies in progress that are assessing various patient outcomes measures. Just as we are constantly innovating our product line, we are also looking to new and innovative ways to better measure patient outcomes as exemplified by the mobile fluoroscopy used in this study.”

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 500 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. To receive future releases in e-mail alerts, sign up at http://ir.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 future clinical studies, future results of clinical studies, the potential clinical, 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 results seen in ongoing and future clinical and economic studies of our products, risks related to our estimates regarding the potential market opportunity for our current and future products, our expectations regarding our sales and other results of operations, 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.

Lynn Granito

Berry & Company Public Relations, LLC

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MINNETONKA, Minn., Oct. 17, 2016 /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 released 12-month fusion and clinical results for patients receiving SImmetry® Sacroiliac (SI) Joint Fusion with decortication. Study results were presented on Saturday morning at the 2016 Society for Minimally Invasive Spine Surgery (SMISS) Annual Meeting by Dr. William Cross, an orthopedic trauma surgeon at the Mayo Clinic in Rochester, Minn.

“Minimally Invasive SI joint fusion has been established as an effective treatment for certain patients suffering from SI joint disorders, but many technologies available today don’t follow the accepted orthopedic principles that lead to successful long-term fusion,” said Dr. Cross, the lead author and presenter at the SMISS scientific meeting. “For me, it’s common sense that SI joint fusion should include decortication and bone grafting to achieve long-term success. The results of this study provide compelling evidence that decortication and bone grafting may contribute to earlier fusion, and that the procedure provides significant pain relief at one year post-op.”

This prospective, multi-center study enrolled 19 patients at three institutions, who underwent a CT scan 12 and 24 months after receiving minimally invasive SI joint fusion with decortication and bone grafting. CT images were reviewed by a non-biased, independent radiology core laboratory to assess fusion in relation to the joint and the area of decortication. At 12 months, fusion was reported in 74% of patients, and back pain decreased from 7.9 to 2.2 (72%). Of patients in whom fusion was reported, 86% showed fusion in the area of decortication. Freedom from device- or procedure-related adverse events through 12 months was 100%. 24-month results for the study are expected in early 2017.

The SImmetry Sacroiliac Joint Fusion System is a minimally invasive procedure intended for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The Company will next exhibit at the 2016 North American Spine Society (NASS) meeting inBoston, Mass., October 26 – 28.

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

About Zyga Technology, Inc.

Zyga Technology, Inc. is dedicated to the research, development and commercialization of solutions that provide empirical clinical and economic value in the treatment of underserved conditions of the spine. In addition to marketing the SImmetry System, the company is conducting a U.S. multicenter clinical study of the Glyder Facet Restoration Device, an investigational, non-fusion, minimally invasive technology intended to provide relief from lumbar facet pain. 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:
Erin Morrison
Tel 952 698 9956
emorrison@zyga.com

Photo – http://photos.prnewswire.com/prnh/20150323/183902
Logo – http://photos.prnewswire.com/prnh/20110118/CG30384LOGO

SOURCE Zyga Technology, Inc.

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Related Topics: Ceramics

SUNNYVALE, Calif., Oct. 14, 2016 (GLOBE NEWSWIRE) — Intuitive Surgical, Inc. (ISRG) today reported that equity awards approved by the Compensation Committee of the Board of Directors, which consists entirely of Independent Directors, were made to 66 new employees. Pursuant to NASDAQ Marketplace Rule 5635(c)(4), the equity awards were granted under the Intuitive Surgical, Inc. 2009 Commencement Incentive Plan, which the Board of Directors of Intuitive Surgical, Inc. adopted for the granting of equity awards to new employees. In accordance with NASDAQ rules, these grants were made under an equity incentive plan without shareholder approval. NASDAQ rules require a public announcement of equity awards to be made under this type of plan. 66 employees were granted a combination of Restricted Stock Units (RSUs) and Stock Options to purchase an aggregate of 10,221 shares of the Company’s common stock; 5,072 of the shares granted were Stock Options and 5,149 of the shares granted were RSUs. Both the RSUs and Stock Options vest over four years. The Stock Options expire in 10 years assuming continued employment. No officers received any award under this plan. The exercise price for the Stock Options granted is $718.04 which was the closing price of Intuitive Surgical, Inc.’s common stock on the NASDAQ Global Market as such price was reported by NASDAQ on October 7, 2016. The Company’s policy is to issue RSUs and Stock Option grants to new employees, where equity makes sense, on the fifth business day of every calendar month.

About Intuitive Surgical, Inc.

Intuitive Surgical, Inc. (ISRG), headquartered in Sunnyvale, California, is the global technology leader in robotic-assisted, minimally invasive surgery. Intuitive Surgical develops, manufactures and markets robotic technologies designed to improve clinical outcomes and help patients return more quickly to active and productive lives. The Company’s mission is to extend the benefits of minimally invasive surgery to the broadest possible base of patients. Intuitive Surgical – Taking surgery beyond the limits of the human hand™.

About the da Vinci® Surgical System

The da Vinci® System is a breakthrough surgical platform designed to enable complex surgery using a minimally invasive approach. The da Vinci® System consists of an ergonomic surgeon console, a patient-side cart with four interactive robotic arms, a high-performance vision system and proprietary EndoWrist® instruments. Powered by state-of-the-art robotic and computer technology, the da Vinci® System is designed to scale, filter and seamlessly translate the surgeon’s hand movements into more precise movements of the EndoWrist® instruments. The net result is an intuitive interface with breakthrough surgical capabilities. By providing surgeons with superior visualization, enhanced dexterity, greater precision and ergonomic comfort, the da Vinci Surgical System makes it possible for more surgeons to perform minimally invasive procedures involving complex dissection or reconstruction. This ultimately has the potential to raise the standard of care for complex surgeries, translating into numerous potential patient benefits, including less pain, a shorter recovery and quicker return to normal daily activities.

Intuitive®, da Vinci®, da Vinci S®, da Vinci® Si™, InSite® and EndoWrist® are trademarks or registered trademarks of Intuitive Surgical, Inc.

For more information, please visit the company’s web site at www.intuitivesurgical.com.

October 14, 2016

US district court judge, Timothy S Black (Southern Ohio, USA) has dismissed the accusation of several hundred plaintiffs that they have been treated off-label with Medtronic’s Infuse.

The plaintiffs were all former patients of Atiq Durrani (Cincinnati, USA), an orthopaedic surgeon indicted in 2013 for providing “medically unnecessary” spinal surgeries. Durrani’s hospital, West Chester Hospital, and its parent company, UC Health, settled allegations of violation of the False Claims Act with a payment of US$4.1 million. The hospital was accused of charging federal healthcare programmes for the “unnecessary” surgeries performed by Durrani. The surgeon now resides in Pakistan, following his indictment.

Medtronic received pre-market approval for the use of Infuse in single-level L4-S1 fusions using an anterior lumbar interbody fusion procedure in combination with the LT-cage. It was indicated as a treatment for degenerative disc disease. MedPageToday, however, reported that up to 80% of the product’s usage was likely to be off-label.

In this case, a number of plaintiffs had been treated without the use of LT-cage, while some had been treated posteriorly. Infuse had been used by Durrani in the cervical and thoracic spine, as well as across multiple levels.

In 2015, the bone morphogenetic protein received approval for three new indications; use in OLIF51 procedures with certain sizes of the Medtronic PEEK Perimeter Implant at a single level from L5-S1, use in OLIF25 procedures with certain sizes of the company’s PEEK Clydesdale Implant at a single level from L2-L5, and use in ALIF procedures with certain sizes of Medtronic’s PEEK Perimeter Implant at a single level from L2-S1.

According to Black, these off-label uses are not necessarily illegal. The plaintiffs had failed to provide sufficient evidence in court as to the harm caused by problems with the Infuse product.

The plaintiffs in this case attempted to argue both that Durrani had committed fraud, acting as an agent of Medtronic, because of his continued use of the Infuse product, in spite of his knowledge of its risks. The patients also argued, however, that Medtronic had itself committed fraud by failing to inform Durrani of the risks associated with the product, according to Black.

“Several courts throughout the country have examined this exact issue and have held that ‘the FDA established specific federal requirements for the Infuse device, even when the Infuse Protein is used alone,’” Black wrote, commenting that the FDA is not required by federal law to publish the adverse event data provided by Medtronic.

Medtronic’s Infuse product has been dogged by controversy since a number of employees failed to report over a thousand adverse events associated with use of the product to the FDA between 2006 and 2008. The adverse events—which included four deaths—were discovered in a retrospective chart review of the product. According to a Star Tribune report, staff failed to notify the FDA about the adverse events, shutting the study down in 2008. By the time news emerged of these unreported adverse events in 2013, most of the Medtronic staff involved in the scandal had left the company, causing confusion within the company itself.

Medtronic attempted to provide more adequate information regarding adverse events in a study run by Yale University, but this, too, has been the subject of some controversy.

October 14, 2016 – Robert Lowes

The federal government today issued final regulations for the Medicare Accountability and CHIP Reauthorization Act (MACRA), which now exclude or exempt between 53% and 57% of physicians and other clinicians from a possible 2019 penalty in the new reimbursement system.

The Centers for Medicare & Medicaid Services (CMS) gave roughly 200,000 more clinicians this break mostly by redefining practices that would not have to participate in the new system because their involvement with Medicare is minimal. In its proposed MACRA regulations, CMS defined such low-volume providers as having less than $10,000 in Medicare-allowable charges and fewer than 100 Medicare patients. By raising the dollar threshold to $30,000 in the final regulations, the agency bumped up the number of low-volume providers from 226,000 to 384,000.

Of these 384,000 low-volume providers, 46% work in practices with fewer than 10 physicians, according to CMS. Organized medicine had complained that many small practices lacked the time, money, and expertise to master the new payment program by the time it goes into effect in 2017. The agency has repeatedly said that it’s heard those complaints and is trying to make the new system more physician-friendly.

MACRA shifts Medicare reimbursement from fee-for-service (FFS) to pay-for-value through a new framework called the Quality Payment Program (QPP). There are two tracks in QPP. The default track, which initially will encompass the most physicians, is the Merit-Based Incentive Payment System (MIPS). It combines three existing incentive programs: meaningful use of electronic health records (EHRs), the Value-Based Payment Modifier, and the Physician Quality Reporting System (PQRS). Physicians will receive a bonus or penalty based on their composite score across the performance categories of quality of care, cost of care, clinical practice improvement, and meaningful use of EHRs, now called advancing care information.

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UT Southwestern Medical Center – October 12, 2016

Researchers successfully boosted the regeneration of mature nerve cells in the spinal cords of adult mammals – an achievement that could one day translate into improved therapies for patients with spinal cord injuries.

“This research lays the groundwork for regenerative medicine for spinal cord injuries. We have uncovered critical molecular and cellular checkpoints in a pathway involved in the regeneration process that may be manipulated to boost nerve cell regeneration after a spinal injury,” said senior author Dr. Chun-Li Zhang, Associate Professor of Molecular Biology at UT Southwestern. Dr. Zhang cautioned that this research in mice, published today by Cell Reports, is still in the early experimental stage and is not ready for clinical translation.

“Spinal cord injuries can be fatal or cause severe disability. Many survivors experience paralysis, reduced quality of life, and enormous financial and emotional burdens,” said lead author Dr. Lei-Lei Wang, a postdoctoral researcher in Dr. Zhang’s lab whose series of in vivo (in a living animal) screens led to the findings.

Spinal cord injuries can lead to irreversible neural network damage that, combined with scarring, can ultimately impair motor and sensory functions. These outcomes arise because adult spinal cords have very limited ability to regenerate damaged neurons to aid in healing, said Dr. Zhang, a W.W. Caruth, Jr. Scholar in Biomedical Research and member of the Hamon Center for Regenerative Science and Medicine.

Dr. Zhang’s lab focuses on glial cells, the most abundant non-neuronal type of cells in the central nervous system. Glial cells support nerve cells in the spinal cord and form scar tissue in response to injury. In 2013 and 2014, the Zhang laboratory created new nerve cells in the brains and spinal cords of mice by introducing transcription factors that promoted the transition of adult glial cells into more primitive, stem cell-like states, and then coaxed them to mature into adult nerve cells.

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