Regulatory

NuVasive Grows Cervical Spinal Interbody Portfolio With PEEK Corpectomy Implant

SAN DIEGODec. 10, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded use of its Monolith®Corpectomy System, providing surgeons with a modular PEEK interbody solution for cervical corpectomy procedures.

The FDA 510(k) indications for expanded use of the Company’s Monolith Corpectomy System include procedures in the cervical spine (C3-C7 vertebral bodies) to treat a diseased or damaged vertebral body caused by fracture, tumors, osteomyelitis or to support reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissue in cervical degenerative disorders.

“Expanding the indicated use of our Monolith Corpectomy System to include cervical corpectomy procedures demonstrates the Company’s continued commitment to expanding our cervical spine interbody portfolio,” said Matt Link, president, Strategy, Technology and Corporate Development for NuVasive. “We are pleased to provide surgeons with a PEEK cervical interbody solution to help round out our cervical portfolio as we continue to advance our mission to improve patient lives.”

NuVasive’s Monolith Corpectomy System was initially cleared by the FDA for indicated use in thoracolumbar corpectomy procedures in 2015, offering a fully modular, imaging-friendly PEEK implant solution. The system is comprised of a monolithic core with modular endcaps that allow surgeons to customize the device to meet the patient’s specific anatomical requirements. The endcaps are available in multiple footprint and lordosis options intended to help maximize endplate coverage while addressing the surgeon’s alignment goals. The Monolith cage is constructed entirely from PEEK and includes radiographic markers, which provides increased clarity in postoperative x-rays and imaging, allowing surgeons to more easily assess fusion following procedures. The cage also includes large central graft apertures designed to help facilitate bony through-growth and fusion.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400-person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

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

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

IntraFuse Granted US Patent for FlexThread™ Intramedullary Fracture Fixation System

LOGAN, UtahDec. 6, 2018 /PRNewswire/ — IntraFuse, a start-up medical device company operated by Surgical Frontiers, is focused on advanced surgical devices for improving outcomes for orthopedic extremity procedures, announced today that the United States Patent and Trademark Office has recently granted the company a key patent related to its FlexThread Intramedullary Fracture Fixation system.

US Patent 10,136,929 entitled “Flexible Bone Implant” is the first patent to issue from the intellectual property portfolio held by the company that includes additional pending US and international patent applications. The patent covers the novel combination of an intramedullary rod with cross fixation on end and a flexible bone screw on the other end. This platform technology enables percutaneous, secure fracture fixation of long bones of the extremities, especially for curved bones or where the surgical technique requires an off-axis approach to the intramedullary canal.

The simple and elegant design is easier to implant and lower cost than today’s standard-of-care fracture fixation hardware. Incorporating IntraFuse’s proprietary FlexThread technology, the distal end of the implant is a flexible, intramedullary screw and the proximal end is a rigid, high-strength intramedullary rod. Upon insertion of the implant into the bone, the rigid rod portion of the implant spans and supports the fracture and the flexible screw portion bends as needed to thread into the intramedullary canal. With internal screw fixation on one side of the fracture and cross screw fixation through the rod on the other side of the fracture, proper bone alignment and length can be maintained during the healing period.

The FlexThread System is currently FDA 510(k) cleared for fibula and clavicle indications, and the FlexThread™ technology is in further development for additional indications, include fractures of the fifth metatarsal bone, also known as a Jones fracture.

IntraFuse is a development stage medical device company incubated and operated by Surgical Frontiers.

About Surgical Frontiers
Surgical Frontiers develops advanced surgical technologies that are ready for clinical use.   Focused primarily on musculoskeletal injuries and pathologies, the company collaborates with surgeons, industry, universities, and investors to bring advanced surgical technologies to the market that improve healthcare.

Media Contact:
Mr. Wade Fallin 
CEO
205883@email4pr.com 
http://surgicalfrontiers.com/intrafuse/ 
800-230-3710

SOURCE Surgical Frontiers

Related Links

http://surgicalfrontiers.com

Hospitals sue over site-neutral payment policy

By Susannah Luthi  | December 4, 2018

The American Hospital Association on Tuesday led a lawsuit against the Trump administration over the CMS’ final rule imposing a site-neutral payment policy, which cuts some Medicare rates for outpatient hospital sites to match the rates for physicians’ offices.

The lawsuit, filed in the U.S. District Court for the District of Columbia, challenges the “serious reductions to Medicare payment rates” as executive overreach. The rate reduction is scheduled to start Jan. 1. In 2019, hospitals’ reimbursements will drop approximately $380 million in 2018, according to the CMS.

“This court should reject CMS’ attempts to replace Congress’s unequivocal directives with the agency’s own policy preferences,” the hospitals wrote in their complaint. “CMS may not contravene clear congressional mandates merely because the agency wishes to make cuts to Medicare spending.”

The outpatient pay rule was finalized in November. The timing and strategy of this lawsuit resembles the hospitals’ effort in late 2017 to block roughly $1.6 billion in Medicare Part B drug reimbursement cuts for 340B providers before they went into effect in early 2018. At the last minute, the presiding federal judge tossed that suit as premature because the cuts had not yet gone into effect. Hospitals lost their appeal over the summer and in September lodged their complaint again.

The Association of American Medical Colleges, the trade group of academic centers that will see a big hit from the site-neutral policy, joined AHA, along with three independent health systems: Michigan’s Mercy Health Muskegon, Washington State’s Clallam County Public Hospital and Maine’s York Hospital.

The policy roiled the hospital industry when it was introduced in a proposed rule over the summer. Hospitals have been lobbying Congress to intervene with the administration and reverse the policy.

 

READ THE REST HERE

 

Carmel spine surgeon wins $112M verdict in royalty battle with Medtronic

November 30, 2018 / John Russell

Dr. Rick C. Sasso, an Indiana spine surgeon and inventor, has won a sweeping, five-year legal battle against medical-device giant Medtronic, with a jury this week awarding him $112 million in damages.

Sasso, 58, president of Carmel-based Indiana Spine Group, had claimed that Medtronic had violated a contract by not paying royalties he was due for spinal implants and screw-implant systems he had invented and sold to the company more than a decade ago. The systems became one of the company’s largest product lines, with annual sales of more than $200 million.

Along the way, Medtronic paid Sasso more than $20 million in royalties, but he contended the company shortchanged him, breaching its obligations and acting in bad faith.

A six-person jury in Marshall County Circuit Court returned the verdict in favor of Sasso on Wednesday, wrapping up a nearly month-long trial.

Medtronic—based in suburban Minneapolis with operations in Warsaw, Indiana—had acknowledged that Sasso played a role in inventing several products. But the company argued Sasso was seeking payment “far in excess of the value of his contributions.”

In a regulatory filing Thursday, the company said it has “strong arguments to appeal the verdict” and will file post-trial motions with appellate courts.

But Sasso’s attorney, Frederick Emhardt of Plews Shadley Racher & Braun, said the jury—which included two science teachers–spoke loudly with their verdict, sifting through a complicated set of facts and circumstances.

“After a month of evidence, they learned much about spine surgery and the business of medical device sales and the need to honor contractual commitments, even if they were made by persons no longer with a company,” he said in an email. “In a period of six hours, they unanimously rendered a verdict awarding to a dollar what Dr. Sasso requested—$112,452,269. The jury system is a bedrock of our way of life. It worked exactly the way intended by our founders.”

Inventive surgeon

For more than a decade, Sasso appeared to have a model business relationship with Medtronic, one of the nation’s largest makers of spinal devices.

Court papers show Sasso considered himself a key member of the invention and engineering team at Medtronic. In one filing, he pointed out that he “attended several retreats with executives and engineers of Medtronic Spine and other inventors/surgeons like himself.” He added that he “contributed know-how and technical information to all phases of Medtronic Spine’s product designs.”

In addition to being an inventor, Sasso “is a world-class—and that’s not exaggeration—spine surgeon,” Plymouth-based attorney Jere L. Humphrey, who served as local counsel in the case, told the Pilot News in Plymouth, Indiana, where the trial was held. “He goes all over the world and gives instructions on how to do spine surgery.”

Sasso in recent weeks did not respond to several requests from IBJ to comment on the dispute. But in voluminous court filings and interviews with other outlets over the years, a picture emerges of a focused surgeon interested in finding new ways to do things.

He grew up in Warsaw, a city nicknamed the orthopedic capital of the world for the prevalence of medical-device companies focusing on the spine and joints. Sasso’s father was a veterinarian, and as a boy, Sasso wanted to become one too. He was accepted into Purdue University, but on his father’s advice, he changed his sights to human medicine and entered Wabash University, according to a 2007 profile story in the college magazine.

After getting his bachelor’s degree in 1982, Sasso entered the Indiana University School of Medicine, and later did his residency in orthopedic surgery at the University of Texas Medical School in Houston.

During a fellowship at Northwestern University in Chicago, Sasso noticed that surgeons had a difficult time tending certain spinal fractures and were still using primitive methods, such as wires, rods and big hooks.

“Nothing made sense,” Sasso told Wabash magazine. “Nothing worked. I’m training with these world experts and they say, ‘Oh yeah, this is the way we do things.’ I think, ‘This is the most ridiculous way.’”

So he soon began experimenting with a new system of his own. In 1994, Sasso and an engineer, Dan Justin, filed a patent application for a spine-implant device, involving screws and rods that would provide stability in the upper neck.

Around the same time, Sasso formed a start-up company, See LLC, with his brother and father-in-law, to manage his intellectual property. He and Justin were issued a patent in 1997.

They initially had trouble getting medical device companies interested in the invention because there were no similar surgical systems on the market, according to court papers filed by Sasso.

But Sasso finally had a breakthrough after being introduced to Robert Compton, an Indiana venture capitalist who was president of Sofamor Danek Group, a maker of spinal instruments based in Memphis, Tennessee, that had operations in Warsaw.

Compton is well-known in Indiana as one of the early financial backers of the email-marketing firm ExactTarget, which was cofounded by Sasso’s brothers-in-law, Scott Dorsey and Chris Baggott. See LLC transferred its intellectual property rights to Sofamor Danek in return for $100,000 in cash, 1,500 shares of stock, and royalties.

Just a year later, Sofamor Danek Group was acquired by Medtronic for $3.3 billion, and in the ensuing years, Sasso entered into several agreements with Medtronic for a series of medical devices related to spinal stabilization.

Histogenics and FDA Continue to Discuss NeoCart® Phase 3 Clinical Trial Data and Potential Regulatory Pathway

WALTHAM, Mass., Nov. 29, 2018 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq: HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, today provided an update on the NeoCart regulatory pathway based on its ongoing dialogue with the U.S. Food and Drug Administration (the FDA).  Since the initial Type C meeting in October 2018, Histogenics and the FDA have continued their discussions on the clinical data generated to date, the potential need for any additional supplemental clinical data (which may include longer-term data from the ongoing Phase 3 trial or additional studies) and potential alternative regulatory pathways for the NeoCart Biologics License Application (BLA).  The FDA has not yet made a final decision regarding a potential BLA submission.  Histogenics intends to provide a further update by the end of 2018 or early 2019 based on additional feedback from the FDA, once available.

“We very much appreciate the FDA’s consideration and active review of our request to evaluate the existing Phase 3 clinical data for a potential NeoCart BLA submission.  We continue to work very closely with the FDA to review the data from the NeoCart development program.  Our discussions have covered many areas including the clinical data, patient population and related statistics from the NeoCart Phase 3 clinical trial, potential alternative pathways for the BLA as well as the current treatment paradigms for knee cartilage defects in relation to the design of the NeoCart Phase 3 clinical trial,” said Adam Gridley, President and Chief Executive Officer of Histogenics.  “We continue to believe, based on the totality of the data, that NeoCart, if the BLA were accepted and approved by the FDA, may offer patients a treatment alternative that provides a more rapid recovery from pain and return to daily activity than other currently available options to treat damaged knee cartilage.”

About Histogenics Corporation

Histogenics (Nasdaq: HSGX) is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function.  Histogenics’ lead investigational product, NeoCart, is designed to rebuild a patient’s own knee cartilage to treat pain at the source and potentially prevent a patient’s progression to osteoarthritis.  NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use.  NeoCart is designed to perform like articular hyaline cartilage at the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as compared to the current standard of care. Histogenics’ technology platform has the potential to be used for a broad range of additional restorative cell therapy indications.  For more information on Histogenics and NeoCart, please visit www.histogenics.com.

Forward-Looking Statements

Various statements in this release are “forward-looking statements” under the securities laws.  Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements.  Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.

Important factors that could cause actual results to differ materially from those reflected in Histogenics’ forward-looking statements include, among others:  expectations regarding the timing and success of ongoing discussions with the FDA regarding the potential submission or acceptance of a BLA for NeoCart; NeoCart’s potential as a treatment for knee cartilage damage; the timing, associated expenses and ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; the market size and potential patient population in markets where Histogenics’ and its partners expect to compete; updated or refined data based on Histogenics’ continuing review and quality control analysis of clinical data; the scope, progress, timing, expansion, and costs of developing and commercializing Histogenics’ product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials following its technology transfer and manufacturing location transition; Histogenics’ expectations regarding its expenses and revenue; Histogenics’ ability to obtain additional debt or equity capital; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2017 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, which are on file with the SEC and available on the SEC’s website at www.sec.gov.  In addition to the risks described above and in Histogenics’ Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics’ results.  Histogenics has not yet received the official FDA meeting minutes from the Type C meeting and the information in this Press Release may be altered or supplemented by the information contained in the official meeting minutes or any subsequent meetings that may be held with the FDA.

There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics.  Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein.  Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf.  The information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

FDA Clears SpinalCyte IND Application for Universal Donor Cell Therapy to Treat Lower Back Pain

November 28, 2018

HOUSTON–(BUSINESS WIRE)–SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc nucleus using its universal donor product, CybroCell™, today announced the FDA has cleared its Investigational New Drug (IND) protocol for human trials in the U.S., considered to be the first IND approval for a fibroblast cell therapy in a chronic condition outside of dermatological uses. The clearance allows SpinalCyte to begin recruiting and screening patients for the study. The trial is to be initiated after the first production run is tested for quality and safety to meet the FDA stated criteria.

“The clearance of the IND for our fibroblast-based therapy, CybroCell™, in the treatment of degenerative disc disease validates our clinical science and is our biggest step toward commercialization,” said SpinalCyte Chief Executive Officer, Pete O’Heeron. “After the extremely positive results from our Phase 1/Phase 2 clinical trial, this clearance by the FDA will allow us to continue testing CybroCell™ and will further our mission of bringing back pain relief to the millions of Americans who suffer from it every year. The applications of CybroCell™ go beyond degenerative disc disease and hold promise in other disease pathways including cancer, diabetes, osteoarthritis, liver failure and heart failure.”

The Phase 1/Phase 2 trial assessed pain and structural improvements in patients using the Oswestry Disability Index (ODI), Visual Analogue Scale (VAS) and MRI scans. The data showed that 54% of the treatment arm patients met all three endpoints as compared to only 17% with the placebo (p=0.0003). More than 90% of patients in the treatment group had an over a 10-point reduction in Oswestry Disability Index (ODI), 100% had improvement in Visual Analogue Scale (VAS) and over 84% had an increase or no change in disc height.

“CybroCell’s pain and MRI data show clear superiority to all other cell therapy treatments for degenerative disc disease,” said SpinalCyte Chief Scientific Officer, Thomas Ichim, Ph.D. “This IND clearance allows us to continue our research and application of CybroCell™. This treatment which targets the source of chronic pain in degenerative disc disease is a medical breakthrough. The persistent structural and functional improvements we have observed in patients demonstrate that CybroCell™ has the potential to help combat the opioid epidemic by eliminating chronic pain.”

About Degenerative Disc Disease

Degenerative disc disease (DDD) is a condition in which a patient’s spinal disc breaks down and can begin to collapse. It is estimated that 85% of people over the age of 50 have evidence of disc degeneration and over 1.3 million procedures a year are performed to treat the disease. The most common treatments for patients with DDD are either discectomy or spinal fusion. Discectomy is the partial or full removal of the degenerated disc to decompress and relieve the nervous system but can cause long term spinal pain. In a spinal fusion procedure, the entire disc is removed and the two adjacent vertebrae are fused together. It often increases strain on the adjacent discs and surrounding tissues leading to further degeneration.

About CybroCell™

CybroCell™ is the first off-the-shelf allogenic human dermal fibroblast (HDF) product for the treatment of degenerative disc disease. SpinalCyte’s Phase 1/Phase 2 clinical trial for injected human dermal fibroblasts in the treatment of DDD demonstrated after 12 months, patients who were injected with CybroCell™ had sustained improvement in pain relief and increased back mobility.

About SpinalCyte

Based in Houston, Texas, SpinalCyte, LLC is a regenerative medicine company developing an innovative solution for spinal disc regeneration using human dermal fibroblasts. Currently, SpinalCyte holds 35 U.S. and international issued patents and has filed for an additional 41 patents pending. SpinalCyte holds 116 U.S. and International Patents pending and issued across a variety of disease pathways, including disc degeneration, cancer, diabetes, liver failure and heart failure. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement in cell therapy. Visit www.spinalcyte.com.

Contacts

David Schull or Ned Berkowitz
Russo Partners LLC
858-717-2310
646-942-5629
david.schull@russopartnersllc.com
ned.berkowitz@russopartnersllc.com

SpinalCyte, LLC
info@spinalcyte.com

United Orthopedic Corporation Announces FDA Clearance for Vitamin E Highly Cross-Linked Polyethylene Hip Liner

IRVINE, Calif.Nov. 27, 2018 /PRNewswire/ — United Orthopedic Corporation, a leading international designer, manufacturer, and distributor of innovative orthopedic implants and instruments, today announced that the U.S. Food and Drug Administration has cleared its vitamin E highly cross-linked polyethylene (E-XPETM) hip liner. The E-XPE™ is the new generation of highly cross-linked polyethylene blended with vitamin E to enhance wear resistance without compromising oxidative stability and mechanical properties.

“Oxidation continues to be a concern for surgeons. Over time, wear of conventional polyethylene can generate debris in the joint, triggering local inflammation that results in bone loss which is one of the biggest causes of late-term failure in hip and knee replacements,” said Calvin Lin, President of United Orthopedic Corporation USA. “Clearance of our E-XPETM, a vitamin E highly cross-linked polyethylene, provides surgeons with an alternative implant for their patient. Our vertically integrated manufacturing process affords us the flexibility to design, manufacture and distribute implants or instruments that address many of the most significant needs in the orthopedic industry.”

Vitamin E is an effective biological antioxidant which helps prevent the oxidative degradation of cell membrane phospholipids. When added to ultra-high molecular weight polyethylene (“UHMWPE”), vitamin E performs a similar role by helping to prevent oxidation of the polyethylene chains.1 Vitamin E -stabilized UHMWPE is a biocompatible material with good mechanical, wear, and oxidative proprieties. Results from accelerated aging tests show that E-XPE inserts and liners exhibited a 60 percent and 75 percent reduction, respectively, in gravimetric wear2.  E-XPE material provides greater strength in comparison to re-melted highly crosslinked polyethylene while maintaining oxidation resistance as demonstrated in mechanical tests.

An estimated 4.7 million Americans have undergone total knee arthroplasty (“TKA”) and 2.5 million have undergone total hip arthroplasty (“THA”).The prevalence of THA rises to nearly 6 percent by 80 years of age. The prevalence of TKA rises to nearly 10 percent by 80 years of age.3

About United Orthopedic Corporation

United Orthopedic Corporation is a leading international designer, manufacturer, and distributor of innovative orthopedic implants and instrument sets.

The company offers clinically proven solutions used in primary and revision total hip/knee replacement in addition to oncology applications. The company has implemented and maintains Quality Management Systems compliant with ISO 13485, FDA and CE requirements. To learn more visit www.uocusa.com.

Media Contact
Erich Sandoval
Lazar Partners Ltd. 
Phone: +1 917-497-2867
esandoval@lazarpartners.com

_____________________________
Gigante A, Bottegoni C, Ragone V, Banci L. Effectiveness of Vitamin-E-Doped Polyethylene in Joint Replacement: A Literature Review. J Funct Biomater 2015; 6(3):889-900.

Chang TW, Cheng YW, Lu CK, Liau JJ. Is Highly Cross Linked UHMWPE Blended with Vitamin E a Viable Reduction Wear in TKA? Presented at Orthopaedic Research Society, 2017, San Diego, CA.

Maradit Kremers H, Larson DR, Crowson CS, Kremers WK, Washington RE, Steiner CA et al. Prevalence of Total Hip and Knee Replacement in the United States. J Bone Joint Surg Am 2015; 97(17):1386-97.

SOURCE United Orthopedic Corporation

UK firm sold spinal implants that disintegrated

26 Nov 2018 / 

A UK company’s spinal implants that allegedly moved and eroded in patients, and which are at the centre of legal action, have highlighted potential weaknesses in the way in which some medical devices enter the market, an investigation has revealed.

Documents seen by the Guardian show the plastic discs were approved for sale by the British Standards Institution (BSI) after tests on 30 people over six months.

A customised version was also implanted in nine baboons, according to a paper by members of the company’s own scientific advisory board.

The devices, made by the now-defunct Ranier Technology, which was based in Cambridge, are the focus of legal action brought by prosecutors in Germany against a doctor who implanted them, allegedly without first obtaining fully informed patient consent.

Many of the patients who received them are undergoing surgery to have them removed, with doctors finding some had completely disintegrated, according to an investigation coordinated by the International Consortium of Investigative Journalists, involving the Guardian and BBC’s Panorama.

Ranier Technology was granted CE (Conformité Européenne) safety marks for two implants, Cadisc-L and Cadisc-C. The devices were certified by the BSI in 2010 and 2011 respectively, and once approved were marketed to hospitals across Europe.

The firm gained millions of pounds in backing from investors impressed by its work in developing artificial spinal discs, which it said would bring relief and a normal quality of life to patients suffering degenerative disc disease.

Instead, about half of the patients given the Cadisc-L implants have had to undergo further surgery after the discs apparently disintegrated or moved in their backs, the Implant Files investigation has discovered.

The implants were seemingly beset by problems from the start, according to scientific analysis. The documents seen by the Guardian show that in trials on baboons using a custom-sized version of Cadisc-L the discs had all been put in the wrong place.

A 2009 review of some of the animals noted that “overall six months is a relatively short time to follow an implant up”, but even after that time there appeared “to be worrying changes between the implant and the bone in all but one subject”.

Details of the tests on humans have not been published, but it is known they only ran for six months before the CE mark application, even though the implants were aimed at young patients.

Astura Medical Receives FDA 510(k) Clearance For OLYMPIC MIS Posterior Spinal Fixation System

CARLSBAD, CA – November 26, 2018 – Astura Medical, a high-growth, innovative spine technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Olympic Minimally Invasive Surgery (MIS) Posterior Spinal Fixation System.

The Olympic MIS system delivers a new level of intraoperative flexibility and efficiency by allowing surgeons to customize to their preferred workflow through the utilization of either a traditional jamshidi/guide wire technique, awl-tap wireless technique, or single-step wireless technique for the placement of MIS pedicle screws. The system features an extensive offering of pedicle screw options, including iliac fixation, in either an extended tab (no assembly) or tower/screw (single step assembly) option. Designed to address even the most complex pathologies, Olympic MIS provides the versatility to accommodate multiple rod diameters in either titanium or cobalt chrome in pre-bent lordotic, straight, or pre-bent kyphotic options. The instrumentation further supports a streamlined and reproducible procedural sequence by providing up to 50mm of reduction, along with multiple options for compression or distraction, including the ability to span multiple levels simultaneously.

“With the increasing rates of MIS adoption and further complexity of pathologies being treated, it was paramount that we addressed the wide range of techniques that surgeons are currently utilizing,” said Joel Gambrell, President and CEO of Astura. “I’m proud of the system that our team of engineers and surgeon designers developed. Olympic MIS once again accomplishes our goal of continuing to bring technology to the market that further enhances the ability of our surgeon partners to provide the best in patient care.”

The full commercial release for Olympic MIS in December represents the fourth differentiated technology delivered to the market by the company in 2018.

About Astura Medical

Astura Medical was formed in 2014 with the objective of creating a disciplined, multi-phased approach to developing, manufacturing, and distributing medical devices. With surgeon input and feedback at every stage of development, Astura has created an extensive line of devices of the highest quality and sleekest design.

The two essential pillars that contribute to Astura Medical’s success are high quality products and robust distribution channels. These pillars, combined with passion and innovation, are what drive the Astura team to achieve great success with developing devices and entering them into the marketplace.

For more information, please visit www.asturamedical.com or find us on LinkedIn.

Media Contact:

Steve Haayen

Astura Medical

858.472.8825 steve@asturamedical.com

FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on new steps to modernize FDA’s 510(k) program

November 26, 2018 / FDA Statement

Forty-two years ago, Congress passed the law establishing the framework for evaluating the safety and effectiveness of medical devices. Today, we’re announcing changes to modernize the FDA’s 510(k) clearance pathway, which accounts for the majority of devices that the FDA reviews. We’re pursuing these changes to help keep pace with the increasing complexity of rapidly evolving technology. The new technology that we’re seeing holds tremendous public health promise for patients. But with the advances also come new complexities that can make the review of safety and effectiveness more challenging. The framework we propose is aimed at efficiently advancing beneficial technology to patients, while solidifying FDA’s gold standard for safety.

We believe that where appropriate, new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria. We want to make sure that new devices are evaluated against advances in technology that can improve patient safety and performance. In making these reviews, where appropriate, we want to rely on modern safety and performance criteria. At the same time, we’re going to pursue additional actions that will allow the FDA to retire outdated predicates, especially in cases where we’ve seen safer or more effective technology emerge.

We believe firmly in the merits of the 510(k) process. But we also believe that framework needs to be modernized to reflect advances in technology, safety and the capabilities of a new generation of medical devices. In short, we believe that it’s time to fundamentally modernize an approach first adopted in 1976, when Congress considered the vast diversity of devices that would become subject to the FDA’s regulatory oversight and established many of the predicate devices that served as the basis for 510(k) clearances during the last 40 years.

The 510(k) process allows the FDA to recognize that medical devices exist across a continuum of complexity and risk and that the scope of premarket review should reflect this risk continuum. This is a contemporary approach to regulation. A one-size-fits-all regulatory approach wouldn’t optimize public health outcomes, wouldn’t be efficient in advancing beneficial new technologies to patients, and wouldn’t allow the FDA to effectively prioritize its scientific resources.

Congress’s creation of the 510(k) process was a paradigm shift from the FDA’s regulation of drugs. It recognized the distinct challenges of regulating such a broad, diverse group of medical products. Today, the FDA regulates more than 190,000 distinct devices. Although the regulatory approach to devices is different than for drugs, the public health objective – assuring that all medical products meet the FDA’s standards for safety and effectiveness – is the same.

The 510(k) pathway represents a more contemporary approach to the risk-based regulation of medical products, but this doesn’t mean the pathway is perfect or not in need of change.

The staff of the FDA’s Center for Devices and Radiological Health (CDRH) has leveraged this risk-based paradigm to develop innovative and forward-leaning regulatory policy that meets our gold standard for safety and effectiveness. In recent months, we’ve taken many new steps to advance these goals. Many of these efforts aim at adopting a more modern process that allows the FDA to more readily incorporate new technologies that improve the safety and performance of medical devices into new predicates to serve as benchmarks for future clearances.

Some of the recent innovative policies include efforts to promote the use of real world evidence in regulatory decision-making; to modernize the De-Novo pathway for low to moderate risk novel devices; to enable the use of rigorous, consensus objective criteria to serve as a predicate for future clearances; to build a national patient safety net; to re-envision a regulatory paradigm for digital health products and in vitro diagnostics; and to chart a premarket review path for breakthrough products. At the same time, we’ve also advanced pathways that can help enable timely patient access to new, innovative and potentially transformative medical devices to help safely treat devastating diseases. For instance, we’ve promoted new ways to safely advance medical devices to diagnose cancer, repair damaged hearts and manage diabetes.

Advances in material science, digital health, 3D printing and other technologies continue to drive an unparalleled period of invention in medical devices. It’s vital that the FDA’s regulatory approach continue to evolve and modernize to safely and efficiently advance these opportunities. Not only must we keep pace with this complexity and innovation, but we must also stay ahead of the new and evolving risks that sometimes accompany this progress.

That’s why, this past April, FDA issued its Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health. We recognized that there were opportunities for us to continue to enhance our programs to help improve device safety. Our policy ideas spanned the life cycle for devices, including ways to drive innovation of safer devices premarket, and enhance post market patient safety. We’ve made significant progress to advance that plan.

Modernizing the 510(k) Pathway

As part of the Safety Action Plan, we committed to strengthen and modernize the 510(k) program. This is a pathway used for clearance of low- to moderate-risk devices that are substantially equivalent to a device already on the market – otherwise known as a predicate device.

FDA’s 510(k) program is the most commonly used device premarket review pathway. In 2017, CDRH cleared 3,173 devices through the 510(k) pathway, representing 82 percent of the total devices cleared or approved. The 510(k) program has been strengthened and refined in many ways. This has been especially true in recent years, as CDRH made a systematic, concerted effort to improve the program’s performance, predictability, efficiency and safety.

Today, following the close of the public comment period and our review of the feedback on the Safety Action Plan, we’re announcing new steps and proposed actions to substantially build on these efforts. We’re focusing on new policy efforts that we plan to advance to help the 510(k) program keep pace with innovation, promote modern patient care and match our evolving understanding of benefits and risks. Our new plans are aimed at continuing to ensure that new and existing devices meet our gold standard for safety and effectiveness as technology rapidly advances.

The most impactful way that we can promote innovation and improved safety in the 510(k) program is to drive innovators toward reliance on more modern predicate devices or objective performance criteria when they seek to bring new devices to patients.

In the 510(k) pathway, manufacturers generally rely on comparative testing against predicate devices to show that a new device is as safe and effective as the predicate device. Older predicates might not closely reflect the modern technology embedded in new devices, or our more current understanding of device benefits and risks. In some cases, the predicate could be decades old. Data show that nearly 20 percent of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

We believe that newer devices should be compared to the benefits and risks of more modern technology; that is why we’re looking at ways to promote the use of more recent predicates. To advance these goals, in the next few months CDRH is considering making public on its website those cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are more than 10 years old as a starting point, so that the public is aware of those technologies. Our goal in focusing on older predicates is to drive sponsors to continually offer patients devices with the latest improvements and advances.

 

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