Regulatory – Page 34

March 15, 2017

SAN DIEGO–(BUSINESS WIRE)–DJO Global, Inc. (“DJO” or the “Company”), a leading global provider of medical technologies designed to get and keep people moving, today announced that its Exprt® Revision Hip portfolio received market clearance by the U.S. Food and Drug Administration. Exprt® Revision Hip is the latest addition to DJO Global’s Exprt® portfolio – a platform defying conventional approaches to total joint implants by improving outdated designs, focusing on patient outcomes and reinventing traditional price points.

The 12,000 surgeons expected to attend this year’s Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS booth #1733) in San Diego, CA will have an opportunity to preview the full-line, modular femoral stem inspired by the clinical success of Wagner-style predecessors. The system’s intuitive design and premium quality is based on extensive research and development that redefines revision total hip arthroplasty by offering an anatomically inspired design that has an emphasis on efficiency and strength – all for 40-70% of the price of comparable revision hip systems.

“One of the biggest challenges our healthcare system encounters is introducing modern technologies at increased price points. The latest addition to the Exprt portfolio signifies our deep commitment to not only clinical outcomes, but both surgical and cost efficiencies,” said Mark Russell, Senior Vice President of the Surgical division of DJO Global.

The two-tray revision system represents an 80-90% reduction in instruments compared to competitive systems. Streamlined instrumentation translates into less money and time spent on sterilization, less overall time in the operating suite, and less storage space – appropriate for both hospital and ASC settings.

Exprt Revision Hip was developed in partnership with industry leading physicians. Michael Taunton, M.D. at the Mayo Clinic and design team member of the Exprt Platform was one of the first surgeons to implant the device. “Having a thoughtful approach to introducing new technology in today’s healthcare landscape will drive shifts in the market place. We designed DJO Global’s Exprt Revision Hip and Knee Systems to challenge conventional approaches to revision arthroplasty. These systems allow me to do what I used to think wasn’t possible – treat my patients with a high-quality implant with improved surgical efficiency and reproducible outcomes while simultaneously being economically responsible.”

For more information on the Exprt portfolio – including Revision Hip and Knee – please visit: www.exprtprecision.com

About DJO Global

DJO Global is a leading global provider of medical technologies designed to get and keep people moving. The Company’s products address the continuum of patient care from injury prevention to rehabilitation after surgery, injury or from degenerative disease, enabling people to regain or maintain their natural motion. Its products are used by orthopaedic specialists, spine surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of the Company’s medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. The Company’s product lines include rigid and soft orthopaedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. The Company’s surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. DJO Global’s products are marketed under a portfolio of brands including Aircast®, Chattanooga, CMF™, Compex®, DonJoy®, ProCare®, DJO® Surgical, Dr. Comfort® and Exos™. For additional information on the Company, please visit www.DJOglobal.com.

Safe Harbor Statement

This press release contains 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. Such statements relate to, among other things, the Company’s expectations for the success of the Exprt® product portfolio. The words “believe,” “will,” “should,” “expect,” ”target,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement. These forward-looking statements are based on the Company’s current expectations and are subject to a number of risks, uncertainties and assumptions, many of which are beyond the Company’s ability to control or predict. The Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. The important factors that could cause the results of the Exprt Hip products and other Exprt portfolio products to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to: the complexities and uncertainties associated with the development of new products; the uncertainties associated with acceptance of the new products by surgeons and patients; new product introduction and other business strategies relative to our Surgical Implant segment; the continued growth of the markets the Company addresses and any impact on these markets from changes in global economic conditions; the impact of potential reductions in reimbursement levels and coverage by Medicare and other governmental and commercial payors; the Company’s highly leveraged financial position; the Company’s ability to successfully develop, license or acquire, and timely introduce and market new products or product enhancements; risks relating to the Company’s international operations; resources needed and risks involved in complying with government regulations and government investigations; the availability and sufficiency of insurance coverage for pending and future product liability claims; and the effects of healthcare reform, Medicare competitive bidding, managed care and buying groups on the prices of the Company’s products. These and other risk factors related to DJO are detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission on March 25, 2016. Many of the factors that will determine the outcome of the subject matter of this press release are beyond the Company’s ability to control or predict.

Contacts

DJO Investor/Media Contact:
DJO Global, Inc.
David Smith
SVP and Treasurer
760-734-3075
ir@djoglobal.com

RAYNHAM, Mass., March 13, 2017 /PRNewswire/ — OMNIlife science, Inc. (“OMNI™”), a privately-held, established medical technology company targeting the $15 billion global hip and knee replacement device market, announced today the first clinical use of a novel robotic tissue balancing device for use with OMNI’s market-leading OMNIBotics® robotic-assisted total knee replacement technology platform. The successful initial procedure took place in Sydney, Australia and was performed by Dr. Brett Fritsch, MD, FRACS, who is also a member of OMNI’s surgeon clinical evaluation and research team. The device has received the CE Mark and a 510(k) has been submitted to FDA for clearance in the United States.

The OMNIBotics system enables optimized knee implant placement using robotics driven by OMNI’s proprietary ART™ software. With more than 13,000 OMNIBotics procedures performed to date worldwide, it provides patient-specific procedures and eliminates the need for preoperative CT scans or x-rays. Intraoperative adjustments are easily made, and the precise alignment of the implant may lead to a more rapid recovery and a more natural feeling total knee replacement.¹ This new robotic tissue balancing device takes patient-specificity one step further and customizes the procedure not only from a skeletal perspective but also from a soft tissue perspective.

“The OMNIBotics tissue balancer provides dynamic real time feedback on the interplay between the soft-tissue envelope and bone cuts in Total Knee Replacement,” said Dr. Brett Fritsch. “Providing a quantitative tool to actively manage soft tissue in combination with the accuracy of a robotic bone cutting guide has the potential to be a significant step forward towards a more natural feeling knee replacement for the patient.”

“The main objective of the OMNI robotics development program is to leverage the capabilities of robotics to assist orthopaedic surgeons in improving patient outcomes at a lower overall cost for the episode of patient care,” said Rick Randall, OMNI CEO. “Our surgeon customers believe a properly aligned and balanced knee throughout the entire range of motion will lead to optimized patient outcomes. The unique capability of robotic-assisted soft tissue balancing, added to the OMNIBotics alignment of the APEX Knee™ is an exciting breakthrough that further advances our value-based outcomes goals.”

ABOUT OMNI

OMNI is a privately held company with a proprietary robotic platform, OMNIBotics®, which allows surgeons to conduct patient-specific total knee surgery designed to enhance patient satisfaction and reduce hospital costs. In addition, OMNI designs, engineers, manufactures and distributes a wide range of proprietary hip and knee implants and is focused on providing cutting edge technologies to transform outcomes in joint replacement surgery and enhance a surgeon’s ability to help patients live active and pain-free lives. For more information about OMNI, please visit www.omnils.com.

FORWARD LOOKING STATEMENTS

Statements in this press release concerning the future business, operations and prospects of OMNIlife science, Inc., including its plans specific to OMNIBotics systems, as well as statements using the terms “plans,” “believes” or similar expressions are “forward-looking” statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based upon management’s current expectations and are subject to a number of factors and uncertainties. Information contained in these forward-looking statements is inherently uncertain, and actual performance and results may differ materially due to many important factors. Such factors include, among others, changes in competitive conditions and pricing in OMNI’s markets, decrease in the demand for OMNI’s products, delays in OMNI’s product research and development cycles, decreases in the use of OMNI’s principal product lines or in procedure volume, unanticipated issues in complying with domestic or foreign regulatory requirements related to OMNI’s current products or securing regulatory clearance or approvals for new products or upgrades or changes to OMNI’s current products, the impact of the United States healthcare reform legislation on hospital spending and reimbursement, any unanticipated impact arising out of the securities class action or any other litigation, inquiry, or investigation brought against OMNI, increases in costs of OMNI’s sales force and distributors, and unanticipated intellectual property expenditures required to develop, market, and defend OMNI’s products. OMNI cannot guarantee any future results, levels of activity, performance or achievement. OMNI undertakes no obligation to update any of its forward-looking statements after the date of this press release.

CONTACT
Cindy Holloway, Director of Marketing Communications Phone: (508) 824-2444
cholloway@omnils.com

¹Ritter, Et al. “The Effect of Alignment and BMI on Failure of Total Knee Replacement”. J Bone Joint Surg, 2011; 93- A:1588-96.

SOURCE OMNIlife science, Inc.

Contacts

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

THORNTON CLEVELEYS (UK) (PRWEB) MARCH 08, 2017

The US Food and Drug Administration (FDA) has recently reclassified semi-rigid spinal stabilization systems from Class III to Class II (*) offering a regulatory pathway to 510(k) clearance in the United States for innovative devices using PEEK-OPTIMA™ polymer based rods from Invibio Biomaterial Solutions (“Invibio”). When compared to rigid systems, semi-rigid PEEK-OPTIMA rods can deliver similar benefits to titanium and are strong enough to stabilize the spine. The FDA decision supports the safety of semi-rigid systems and provides greater options for surgeons who prefer more flexibility than traditional rigid pedicle screw systems to achieve fusion.

Invibio collaborated closely with medical device manufacturers and the FDA to provide clinical and biomechanical data in support of the use of semi-rigid PEEK-OPTIMA rods for spinal stabilization. The pioneering development and reclassification is expected to assist the medical profession in achieving progress in enhanced spinal fusion systems and procedures.

Clinical evidence: Invibio to support OEMs further with their submissions to the FDA

“The down classification of PEEK-OPTIMA rods as a Class II technology for spinal fusion is a welcome and progressive development for the medical device market. Substantial evidence was presented in reaching this conclusion, including data from over 51,000 PEEK rod implantations. We now have a growing body of clinical evidence that systems based on Invibio´s PEEK-OPTIMA rods have clearly defined advantages over all-metal constructs and have the potential to drive the future of posterior spine stabilization,” commented John Devine, Invibio medical business director.

“Healthcare globally is under pressure to control costs which is why Invibio offers PEEK-OPTIMA spinal rod components to the manufacturer. Compiling evidence that supports the safety and clinical benefits of our materials enables us to also provide an efficient route to market for our customers in terms of manufacturing and regulatory clearance. We look forward to working with our customers to achieve clearance for semi-rigid systems in order to offer improved options for surgeons and ultimately patients,” concluded Devine.

Metal alternative offers distinct advantages

For some time, the medical profession has been aware that spinal-rod components made from PEEK-OPTIMA polymers may be used as an alternative to metal to achieve semi-rigid fixation with posterior pedicle screw systems as an adjunct to fusion. And in fact, they offer distinct advantages over stabilization systems constructed from a metal such as titanium.

“PEEK-polymer solutions are widely recognized for spinal interbody fusion and are frequently used. The versatile PEEK-OPTIMA has a modulus close to that of human bone, and this allows it to be a natural bridge between very rigid metal implants, such as the titanium constructs, and more dynamic approaches. In fact, PEEK-polymer implants offer numerous benefits, including radiolucency, which of course metals don’t allow, while retaining the stability of titanium,” commented Dr. Thierry Desjardins, Neurosurgeon (Cagnes-sur-Mer, France), who has been using PEEK-OPTIMA spinal rods since June 2011 and has always been reluctant to use too rigid a system as this could accelerate degeneration at adjacent spinal segments.

Semi-rigid rods to bridge treatment gap: improved load sharing can encourage fusion

Spinal rods composed of metal are not without challenges, including, but not limited to, rod breakage, the loosening of screws, and accelerated degeneration at adjacent spinal segments. The high stiffness inherent in all-metal constructs is believed to contribute to these clinical challenges and negatively impact patient outcomes.1,2 In addition, a metal such as titanium lacks artifact-free imaging, and inevitably this impacts the ability of surgeons to position stabilization systems accurately.

PEEK-OPTIMA polymer based stabilization, on the other hand, effectively functions as a ‘bridge’ approach. Rods made from the material have sufficient strength to reduce the range of motion2,3 in order to stabilize the treated segment4, but possessing a modulus similar to that of cortical bone, they still allow physiological movement on adjacent upper and lower segments.3 As a result, clinical results increasingly suggest that PEEK-OPTIMA spinal rod components preserve or slow down the degeneration of adjacent discs.5 As a consequence, patients may benefit from improved load sharing to encourage fusion,2,6,7 and more physiologic loading at adjacent levels, which may decelerate degeneration.8,9

To learn more, please visit Invibio at the AAOS Annual Meeting – Booth 3545 – March 15-17, 2017

For more information please visit http://bridgethefusiongap

(*) The US Food and Drug Administration (FDA) renamed dynamic stabilization systems as “semi-rigid systems,” and defined them as a sub-type of pedicle screw systems, now referenced as “thoracolumbosacral pedicle screw systems”.
Further information for the final ruling can be found at “Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems.”

REFERENCES
1.Highsmith JM, et al. (2007). Flexible rods and the case for dynamic stabilization. Neurosurgical Focus, 22, 1-5.
2.Gornet MF, et al. (2011). Biomechanical Assessment of a PEEK Rod System for Semi-Rigid Fixation of Lumbar Fusion Constructs. Journal of Biomechanical Engineering, 133, 1-12.
3.Ponnapan RK, et al. (2009). Biomechanical evaluation and comparison of polyetheretherketone rod system to traditional titanium rod fixation. The Spine Journal, 9, 263-267.
4.Turner JL, et al. (2010). The mechanical effect of commercially pure titanium and polyetheretherketone rods on Spinal implants at the operative and adjacent levels. Spine, 35(21), E1076-E1082.
5.Athanasakopoulos M, et al. (2013) Posterior Spinal Fusion Using Pedicle Screws. Orthopedics, 36, e951-e957. doi: 10.3928/01477447-20130624-28
6.Moumene M, et al. (2008). Biomechanical Advantages of Expedium PEEK Rods. DePuy Spine, Inc.
7.Galbusera F, et al. (2010). Rigid and Flexible Spinal Stabilization Devices: A Biomechanical Comparison. Medical Engineering & Physics, 33, 490-496.
8.Ormond DR, et al. Polyetheretherketone (PEEK) rods in lumbar spine degenerative disease: a case series. J Spinal Disord Tec, 12(8), 693-701.
9.De Iure F, et al. (2012). Posterior lumbar fusion by PEEK rods in degenerative spine: preliminary report on 30 cases. Eur Spine J, 21(1), S50-S54.
10.Greene RJ, et al. (2011). Photoelastic Analysis of the Full-field Stress Distribution Induced by a Spinal Implant Construct. Poster #746 presented at the 2011 Orthopaedic Research Society Annual Meeting.

About Invibio Biomaterial Solutions
Invibio, a Victrex plc company, is a global leader in providing high performance biomaterial solutions to medical device manufacturers. The company provides PEEK-OPTIMA™ polymers, advanced technical research and support and manufacturing of components for spine, trauma and orthopaedic medical segments for the development of long implantable medical devices. Today, Invibio’s PEEK-OPTIMA™ polymers are used in more than five million implanted devices worldwide.

About Victrex plc
Victrex, headquartered in the UK, is an innovative world leader in high performance polymer solutions focused on the Aerospace, Automotive, Electronics, Energy and Medical markets. Every day, millions of people rely on products or applications which contain our polymers, from smartphones, aeroplanes and cars to oil & gas operations and medical devices. With over 35 years’ experience, we are delivering leading edge solutions to shape future performance for our customers and our markets, and to drive value for our shareholders. Find out more at http://www.victrexplc.com

ALISO VIEJO, Calif., March 7, 2017 /PRNewswire/ — Vertos Medical, a medical device company committed to developing innovative, minimally invasive treatments for lumbar spinal stenosis (LSS), has received national coverage for its mild^® Procedure through a recently approved study under the Centers for Medicare & Medicaid Services’ (CMS) Coverage with Evidence Development (CED) Program. A clinically proven outpatient procedure performed through a portal the size of a baby aspirin, mild requires no stitches, no general anesthesia, no implants, and no overnight hospital stay.

Broad access to the mild procedure has been granted for Medicare patients via a CMS-approved claims-analysis study that will passively collect and analyze real-world data to demonstrate the role of the therapy in the continuum of care for LSS. CMS’s recent decision to expand access follows the successful completion of the company’s CMS-approved randomized controlled study, MiDAS ENCORE.¹

“Patient and physician demand for the mild procedure has grown a great deal, and I’m excited to hear that my patients and fellow practitioners will now have access to this effective, proven method for relieving pain and getting people back to doing the things that make life enjoyable,” said Nagy Mekhail, M.D., Ph.D., Director of Evidence Based Pain Medicine Research and Education at Cleveland Clinic, who is an investigator of previous clinical studies of mild and has been performing the procedure since 2010. “Neurogenic claudication related to lumbar spinal stenosis can be extremely life limiting; this first-line treatment stands to benefit the many patients currently being treated for LSS in the United States, who have no viable treatment options.”

It is estimated that roughly 10% of Americans have lumbar spinal stenosis, and that by 2021 some 2.4 million will be experiencing considerable pain as a result of the condition.

“This is great news for the thousands of people who suffer from the debilitating symptoms related to their lumbar spinal stenosis with neurogenic claudication, who have struggled to find a safe, effective, low-cost solution,” said Eric Wichems, President and CEO of Vertos Medical.

The mild procedure has been studied in more than 20 peer-reviewed publications and 12 clinical trials, and has been performed on more than 20,000 patients. Peer-reviewed clinical data has demonstrated that mild helps patients suffering from LSS stand longer and walk further with less pain.²

¹Benyamin, R., et al. (2016). mild® is an Effective Treatment for Lumbar Spinal Stenosis with Neurogenic Claudication: MiDAS ENCORE Randomized Controlled Trial. Pain Physician, 19: 229-242. ISSN 1533-3159.

² Mekhail, Nagy, et al. (2012). Functional and Patient-Reported Outcomes in Symptomatic Lumbar Spinal Stenosis Following Percutaneous Decompression. Pain Practice, 12(6): 417–425. doi: 10.1111/j.1533-2500.2012.00565.x.

Vertos Medical Inc. is a medical device company committed to developing innovative, minimally invasive treatments for lumbar spinal stenosis (LSS). Its proprietary technologies include mild^®, which offers a safe, outpatient, minimally invasive, fluoroscopically guided therapeutic LSS treatment that requires no general anesthesia, no implants, and no stitches. LSS is primarily a degenerative, age-related narrowing of the lower spinal canal that causes symptoms of pain and numbness in the lower back, legs, or buttocks. mild^®treats this condition by restoring space in the spinal canal using specialized mild^® devices to remove hypertrophic ligamentum flavum through a 5.1-mm treatment portal. Clinical studies show that mild^® can help LSS patients stand longer and walk farther with less pain¹, and no major device-related complications have been reported in any clinical trial.² Vertos Medical headquarters is located in Aliso Viejo, CA. To learn more about how mild^® treats LSS click here.

SOURCE Vertos Medical

WATERLOO, ON, March 7, 2017 /PRNewswire/ – Intellijoint Surgical^® Inc., a privately-held Canadian medical technology company, announces FDA clearance of intellijoint HIP^® Anterior, the newest application to the intellijoint HIP suite. intellijoint HIP Anterior is a 3D mini-optical navigation solution that provides quantifiable, intraoperative measurements for cup position, leg length, and offset to orthopaedic surgeons performing Direct Anterior Approach (DAA) Total Hip Arthroplasty (THA).

“intellijoint HIP Anterior has been developed by a group of brilliant engineers with deep understanding of the steps involved in direct anterior hip replacement, which allows surgeons to integrate the device easily into their workflow,” said Dr. Javad Parvizi, member of Intellijoint Surgical’s Scientific Advisory Board and DAA orthopaedic specialist at Thomas Jefferson University Hospital’s Department of Orthopedic Surgery. “intellijoint HIP Anterior provides quantifiable, intraoperative measurements that allows surgeons to optimally position the components, restore limb length and offset. intellijoint HIP Anterior stands to eliminate fluoroscopy verification for cup position, leg length and offset that is often used by surgeons.”

Per bench top validation testing cleared by the FDA, 20 separate simulations were performed with intellijoint HIP Anterior accurately measuring anteversion to within 0.47°and inclination to within 0.65° when compared to radiographic scans. intellijoint HIP Anterior was intuitively designed to provide cup position measurements in relation to the supine coronal plane or Anterior Pelvic Plane, depending on surgeon’s preference.

“The low-cost fee-per-case pricing model of intellijoint HIP Anterior allows me to utilize navigation for all of my total hip replacements with the Direct Anterior Approach.” commented Dr. Michael Bradley, President/CEO of Orthopedics Rhode Island. “My DAA patients have peace of mind knowing that their hip implants are positioned exactly how I planned pre-operatively, thanks to intraoperative measurements from intellijoint HIP Anterior.”

Intellijoint Surgical will be showcasing the full intellijoint HIP suite including intellijoint HIP Anterior at AAOS 2017 Annual Meeting – Booth #5551 from March 15 – 18, 2017 in San Diego, California, USA. intellijoint HIP Anterior is currently in Limited Market Release and will be available in New York, Illinois, Rhode Island and Houston, Texas in early summer 2017.

About Intellijoint Surgical:

Intellijoint Surgical^® develops and commercializes surgical navigation solutions. Intellijoint’s flagship product, intellijoint HIP^® provides surgeons with real-time, intraoperative measurements to ensure proper positioning of orthopaedic implants during Total Hip Arthroplasty. Intellijoint is committed to driving clinical results through the development of solutions that are accessible, fast, and easy-to-use. Guided by a scientific advisory board comprised of Dr. Allan Gross, an orthopaedic surgeon at Mount Sinai Hospital, and members, Dr. Javad Parvizi at Thomas Jefferson University Hospital, Dr. Michael Cross at Hospital for Special Surgery, Dr. Wayne Paprosky at Rush University Medical Center, and Dr. Ran Schwarzkopf at NYU School of Medicine, Intellijoint is setting the new standard in miniature 3D surgical navigation.

Intellijoint Surgical is the recipient of the 2015 North American Frost & Sullivan Enabling Technology Leadership Award and the Futurpreneur Shopify True Grit Award 2016.

For more information, please visit: www.intellijointsurgical.com

SOURCE Intellijoint Surgical Inc.

Kalamazoo, Michigan, USA – March 7, 2017 – Stryker announced today that its AVAflex Balloon System has received FDA 510(k) clearance and is, for the first time, available with Stryker’s market-leading bone cements and implants and the AutoPlex Mixing and Delivery System.

“Doctors who perform vertebral augmentations are committed to the health and wellness of their patients, and Stryker is committed to empowering those doctors to provide the best possible care,” said Chad Ludwig, marketing director at Stryker Instruments. “The AVAflex Balloon System enables doctors to achieve bipedicular results with a unipedicular approach to vertebral augmentation.”

The AVAflex and AutoPlex systems are used in the treatment of vertebral compression fractures (VCF), which affect an estimated 750,000 Americans each year. VCF patients can suffer from extreme pain and are at an increased risk for serious health problems. Vertebral augmentation, including the use of a balloon system, has been shown to provide patients with significant pain relief and dramatically reduce mortality rates.^,

The AVAflex curved balloon system’s new 11-gauge size allows surgeons to achieve with one insertion and a smaller needle what had previously required two insertions, making procedures less invasive and potentially reducing the risk of patient trauma. Using a minimally invasive technique, physicians can successfully create a midline cavity for targeted cement placement by accessing one pedicle.

AVAflex is now available with Stryker’s bone cements and implants and the AutoPlex Mixer and Delivery System, an easy-to-use bone cement mixing and delivery system. The AutoPlex system provides consistent and thorough blending of components, helping eliminate human error and variability.

Stryker has furthered its mission of making health care better for physicians, hospital staff and patients with the addition of the AVAflex portfolio, which it acquired from Becton Dickinson in 2016. Stryker provides the most complete and least invasive portfolio of vertebral compression fracture treatment options.

With an unrivaled collection of balloon catheters and augmentation options, cements, automated mixers and directional delivery systems, Stryker enables care providers to tailor their approach for the treatment of vertebral compression fractures. Stryker is now the exclusive provider of automatic mixing and delivery systems and 11-gauge curved balloons.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at www.stryker.com.

By Jim Spencer Star Tribune – March 5, 2017

WASHINGTON – When hearings on Supreme Court nominee Neil Gorsuch begin later this month, questions will likely center on hot-button issues like women’s reproductive rights, travel bans, immigrant deportations and state voter identification laws.

But one of the most strongly expressed opinions Gorsuch would bring to the nation’s highest judicial body is a belief that federal law protects medical device makers from lawsuits filed by patients injured by their products.

As an appeals court judge in the U.S. 10th Circuit, Gorsuch wrote an important 2015 opinion that denied a woman the right to sue Medtronic for injuries she said were caused by the company’s improper off-label promotion of its Infuse bone graft.

The Supreme Court declined to hear that case — Patricia Caplinger v. Medtronic — on appeal. In doing so the high court cemented Gorsuch’s interpretation of a legal concept called pre-emption that scholars say will largely deny people hurt by medical devices the right to sue manufacturers in state courts, even if their products were used in ways the U.S. Food and Drug Administration never approved.

In the Caplinger opinion, Gorsuch asserted: “Nothing depends on whether the plaintiff seeks to use state law to impose requirements for off-label uses or on-label uses. Rather, by its terms, the statute pre-empts any effort to use state law to impose a new requirement on a federally approved medical device.”

Gorsuch added that “a state’s judgment that a device is unsafe for a particular off-label use could require design changes that adversely affect the device’s safety for on-label uses.”

Having a Supreme Court justice who takes such an approach is good news for the medical device industry, which employs tens of thousands of workers in Minnesota and is home to one of the country’s most robust medical technology sectors, said John Dornik, an attorney at the Minneapolis firm of Siegel Brill, who also teaches product liability at the University of Minnesota.

READ THE REST HERE

February 27, 2017 by Stewart Eisenhart

EMERGO SUMMARY OF KEY POINTS:

Regulatory issues continue to be the biggest business challenge for medical device companies of all sizes.
Managers at smaller firms report greater concern for funding and capital issues, while largest firms are more challenged by pricing and competition pressures.
Medium- and large-sized firms cite product development as a significant challenge, as well.
Changing regulatory environments continue to present the biggest business challenge for a majority of medical device company senior managers, according to an annual Emergo industry survey.
Asked to identify the biggest business challenge they face as part of Emergo’s 2017 Global Medical Device Industry Outlook, nearly 70% of more than 500 senior managers of medical device companies surveyed cited changing regulatory environments as their top issue. But depending on respondents’ size, other challenges such as product development, profitability and funding were also identified.
Medical device regulatory challenges: still number one

Regulatory issues perennially top the list of business challenges in Emergo’s industry surveys, and this year was no different. But while 66% of senior managers identified regulatory changes generally as their biggest challenge, managers of larger firms were more likely to cite regulatory changes as their top concern.

READ THE REST HERE

March 02, 2017

ALACHUA, Fla.–(BUSINESS WIRE)–Amend Surgical, Inc., a medical device company focused on enhancing the regenerative capacity of bone replacement products, announced today that they have received 510(K) clearance to market NanoFUSE^® BA as a bone graft extender for spine and orthopedic applications.

NanoFUSE BA is a novel composite containing 45S5 Bioactive Glass and a patent protected carrier that provides optimal surgical handling performance and graft stability. Bioactive glass facilitates operative site graft containment through rapid bone bonding and the subsequent activation of cellular osteogenesis (bone formation). It creates a highly favorable environment for bone fusion as it remodels into the recipient’s skeletal system and is an important tool for the orthopedic surgeon. With this most recent clearance Amend Surgical now has two U.S. Food and Drug Administration (FDA) cleared product lines.

“NanoFUSE BA offers our surgeons and their patients a synthetic alternative to NanoFUSE Bioactive Matrix,” stated Robby Lane, president and chief executive officer of Amend Surgical. “We are continuing to expand our market presence with the only demineralized bone bioactive glass combination product on the market and are excited about the opportunities offered by the launch of NanoFUSE BA. This product provides surgeons the superior handling characteristics they expect with the long and successful clinical history of bioactive glass.”

About Amend Surgical

Amend Surgical is a specialty medical device company focused on enhancing the bone healing and regenerative capacity of bone grafts, including allograft, xenograft tissues and synthetic materials. The company’s pipeline includes novel, clinically evaluated, osteoinductive bone extracts, and will expand in the future to disruptive products based on discovery and development of novel therapeutic additives with tissue-specific regenerative characteristics.

Contacts

Amend Surgical, Inc.
Robby Lane, 386-518-5546
President and CEO
rlane@amendsurgical.com
www.amendsurgical.com

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