FDA warns on pain drugs for implantable pumps

FDA-logo-newThe FDA today warned doctors and patients about the serious complications that can occur when using the wrong painkillers with implantable drug pumps.

Dosing errors, pump failure, and infection are just some of the potential problems that can crop up when using drugs that aren’t approved for use with particular devices, the regulatory agency said.

Get the full story at our sister site, Drug Delivery Business News.

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Report: Med device recalls down in Q3

Medical device recalls fell by 21% to 284 in the third quarter of 2018, according to a report by Stericycle Expert Solutions. Machine failure was the top cause of recalls based on units, while software led the way based on numbers of recalls, the report says.

The total number of medtech recalls for Q3 was lower than the last two quarters but higher than the three quarters before that. Recalled units decreased 31% to around 29.4 million — the lowest since Q1 2017.

Get the full story on our sister site, Medical Design & Outsourcing.

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FDA clears Spinal Elements’ surface coating technology

Spinal Elements’ Lucent XP expandable lumbar interbody system with Ti-Bond coating. (Image courtesy of Spinal Elements)

Spinal Elements said that the FDA has issued 510(K) clearance for the macro-, micro-, and nano-surface structure of its Ti-Bond surface coating technology. The Carlsbad, Calif. company said that a number of products in its portfolio use Ti-Bond, including the most recently introduced Lucent XP height- and lordosis-expandable interbody device.

Interbody fusion products with Ti-Bond technology are comprised of a PEEK body designed to provide a favorable modulus and imaging characteristics while the multi-structured Ti-Bond-coated surfaces are designed to provide a favorable environment at the vertebral endplate, according to the company. Ti-Bond was introduced in 2012.

“Spinal Elements has had a long, successful experience with the clinical application of Ti-Bond technology in the spine,” said Jason Blain, president & CEO of Spinal Elements, in a prepared statement. “This FDA clearance represents an important scientific element of the overall Ti-Bond story – one that will expand even more as the platform continues to flourish, and we provide an increasing number of technology-based solutions to improve patient outcomes.”

Ti-Bond does not compromise imaging characteristics, spinal loading conditions, or long-term performance, the company added, saying that the FDA clearance further demonstrates the complex surface environment provided by Ti-Bond coating adjacent to bony structures.

FDA agents inspected Spinal Elements’ Carlsbad, Calif. facility in 2014 and the agency issued a warning letter that dubbed the company’s Lucent and Lucent Ti-Bond devices “adulterated” under federal law because the company did not have an approved application for a PMA or an investigational device exemption (IDE) for the devices. The FDA further chided the company for “unsubstantiated claims” made about a “bulleted” Ti-Bond device that the agency never approved, according to the warning letter.

The letter also knocked the company for performance claims regarding a Ti-Bond device, including claims that the implant’s coating “recruits pluri-potential osteogenic cells,” that it helps “minimize implant migration” and that it is “bioactive.”

The agency issued a closeout letter in November 2017, saying Spinal Elements had addressed the violations detailed in the warning letter. The company did not comment on the warning letter, its resolution, or whether the latest clearance was connected to the warning letter.

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NuVasive wins FDA nod for Cohere XLIF implant components


NuVasive (NSDQ:NUVA) said today it won FDA 510(k) clearance for Cohere porous PEEK implants that are part of its Extreme Lateral Interbody Fusion surgical spinal procedures.

The San Diego-based company touted that its porous PEEK technology offers both three-dimensional architecture and the radiolucent properties of PEEK, which it claims provides “increased clarity in postoperative x-rays and imaging.”

“Cohere XLIF with its one-of-a-kind Porous PEEK technology provides surgeons the best implant for treating patients. It is designed to allow early incorporation of bone into the inter-body spacer, which may lead to the prevention of expulsion and promotion of early fusion which allows a quicker and better way back to an active lifestyle for my patients. Incorporating Cohere Porous PEEK implants into XLIF procedures keeps imaging characteristics that we all love about PEEK implants intact. Cohere XLIF takes the gold standard of lateral interbody fusion and raises the bar, allowing our patients to receive the best surgery with the best implant possible,” Duke Health orthopedic spine surgeon Dr. Christopher Brown said in a press release.

With the clearance, Cohere implants can be used with autograft and/or allograft in skeletally mature patients for thoracolumbar pathologies that include degenerative disc disease, degenerative spondylolisthesis and degenerative scoliosis, NuVasive said.

“It’s exciting to extend our patented interbody technology to the Company’s flagship XLIF procedure, an integral part of our single-position surgery portfolio, as we further our mission to improve patient lives. Cohere XLIF represents the first buildout of a Porous PEEK implant by NuVasive, and we look forward to extending this proprietary technology into additional applications across the Company’s comprehensive procedural solutions,” strategy, tech & corp dev prez Matt Link said in a prepared statement.

Late last week, NuVasive released third quarter earnings that beat Wall Street expectations for revenue but missed on earnings per share consensus.

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FDA approves over-the-counter Primatene Mist inhaler

Amphastar PharmaceuticalsThe FDA this week approved Amphastar Pharmaceuticals‘ (NSDQ:AMPH) over-the-counter Primatene Mist inhaler for the temporary relief of mild symptoms of intermittent asthma.

The original version of Amphastar’s Primatene Mist device was taken off the market in 2011 because it contained chlorofluorocarbon propellants – a chemical compound that is linked to depletion of the Earth’s ozone layer. The company’s latest product contains hydrofluoroalkane propellants, which are permitted under current U.S. law.

Get the full story at our sister site, Drug Delivery Business News.

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Mazor posts Q3 miss, wins FDA nod for Mazor X Stealth edition

Mazor Robotics Mazor X

Mazor Robotics (NSDQ:MZOR) today released third quarter earnings that narrowly missed loss-per-share expectations on Wall Street, and announced that it won FDA clearance for its Mazor X Stealth edition.

The Caesarea, Israel-based company posted losses of $16.9 million, or 32¢ per share, on sales of approximately $10.1 million for the three months ended September 30, seeing losses grow 329.2% while sales shrunk 45.8% compared to the same period during the previous year.

Losses per share were just behind the 4¢ consensus on Wall Street.

Mazor also said that the FDA cleared its Mazor X Stealth Edition system, which integrates Medtronic‘s (NYSE:MDT) Stealth navigation with the Mazor X robotic guidance platform.

The integrated device comes as a headwind to the company’s upcoming acquisition by Fridley, Minn.-based Medtronic, originally announced in September.

The world’s largest medical device maker has held a position in Mazor, which makes the Mazor X guidance system and the Renaissance robot-assisted spine surgery platform, since May 2016. In September they closed the third, $40 million tranche of the investment, giving Medtronic a 10.6% stake it paid $72 million for.

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Siemens wins FDA nod for Cios Spin mobile 3D C-arm

Siemens Healthineers

Siemens (NYSE:SI) Healthineers said today that it won FDA clearance for its Cios Spin mobile C-arm device for intraoperative 3D imaging.

The newly cleared Cios Spin produces 3D computed tomography-like imaging for orthopedic, trauma and spinal surgery that Siemens claims can reduce the rate of revisions and need for post-operative CT.

The Cios Spin supports both 2D and 3D imaging and can be used for a variety of procedures, including vascular imaging, Siemens said. The system also features NaviLink 3D digital navigation and flat panel detector technology and other software packages.

“Siemens Healthineers is proud to offer the Cios Spin, a dynamic new mobile 3D C-arm that illustrates our expertise in mobile X-ray imaging. This system will help our customers improve the quality of patient care using precision medicine as well as reduce the additional costs imposed by revision surgery,” Siemens Healthineers NA surgical solutions VP Robert Dewey said in a press release.

Last month, Siemens Healthineers said that it inked a deal with Healthy.io looking to improve home chronic kidney disease monitoring.

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FDA clears Shoulder Innovations’ InSet short stem shoulder repair system

Shoulder Innovations

Emerging medtech developer Shoulder Innovations said today it won FDA 510(k) clearance for its InSet Humeral Short Stem System intended for partial or total shoulder arthroplasty procedures.

The newly cleared system is intended for use in treating degenerative, rheumatoid or traumatic arthritis in the shoulder and includes new features the Holland, Mich.-based company said address potential problems that exist with current total shoulder replacement systems.

“The combination of the InSet Humeral Stem and Shoulder Innovation’s unique InSet glenoid implant affords a surgically simple, bone sparing option for many types of humeral or glenoid deformities associated with arthritis,” Dr. Robert Tashjian of the University of Utah said in a prepared statement.

“We are excited to see the fast-paced progress and results made by the team. Genesis Innovation Group has moved rapidly in developing this highly innovative new product line.  It plays a pivotal role in the Shoulder Innovations strategy, and Genesis has proven to be an excellent partner in helping our company move forward,” Shoulder Innovations exec chair Rob Ball said in a press release.

Last month, Shoulder Innovations said that it closed a $2.5 million Series A equity financing round to help support continued product development and growth of its existing Inset technology.

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FDA clears NinePoint Medical’s AI-powered IRIS upgrade for Nvision VLE esophageal imager

NinePoint Medical

NinePoint Medical said today that it won FDA 510(k) clearance for the Intelligent Real-time Image Segmentation software upgrade for its flagship Nvision VLE imaging system.

The newly cleared IRIS is an artificial intelligence-based platform for image feature segmentation, the Bedford, Mass.-based company said. The company touted that the approval was the first of its kind for such a tool intended for use in imaging esophageal tissue.

The NvisionVLE Imaging System is intended to facilitate volumetric laser endomicroscopy procedures that create real-time, high-resolution cross-sectional images, NinePoint said. The system is designed for the evaluation of esophageal tissue surface and sub-surface to analyze for potential diseases which may not be visible through traditional imaging tech.

“The clearance of the IRIS product marks the successful culmination of a multi-year development effort within our organization, and with the Food and Drug Administration. This product is something we at NinePoint, and our customers, are very excited to bring to market. We pride ourselves in customer responsiveness and innovation, key inputs to this new product. We are eager to roll this out in a controlled-market release in the coming months prior to making the technology more broadly available,” NinePoint Medical prez & CEO Eman Namati said in a press release.

NinePoint said that the clearance is the first since it inked a strategic collaboration deal with Merit Medical (NSDQ:MMSI), who also serves as its worldwide distributor.

“We are thrilled to continue to see the innovation and development of high quality products from our collaborators at NinePoint. The NvisionVLE Imaging System has been a great strategic addition to the Merit Medical family of GI products, and we look forward to continuing to work together on future product releases,” Merit Medical chair & CEO Fred Lampropoulos said in a prepared statement.

In July, NinEpoint Medical said that it appointed Eman Namati as its new president and chief executive officer, succeeding Christopher von Jako who remained on the company’s board of directors.

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FDA, DoD formalize medical product development deal

FDA, Defense Dept.

The FDA said last Friday that it and the U.S. Department of Defense’s Office of Health Affairs inked a Memorandum of Understanding to support medical product development  intended to support military personnel.

The deal creates a framework through which the FDA and DOD can implement “enhanced engagements” that were part of a law passed by Congress last year.

“We’re extremely grateful to the men and women who defend our nation, often at great personal risk and sacrifice. It’s our honor and duty to support our military personnel by ensuring they have access to safe and effective medical products – especially products that meet the unique needs and settings in which soldiers may require medical treatment. The FDA has already been working closely with the DoD to identify opportunities to expedite availability of medical products, particularly those products used to treat injuries in battlefield settings. For example, as noted below, the Emergency Use Authorization for French freeze-dried plasma that was issued earlier this year. Our close collaboration with DoD has helped us target and more efficiently address DoD’s immediate product priorities and foster development and review of these products in the most streamlined manner possible. We are looking forward to additional partnership opportunities under the MOU,” FDA Commissioner Dr. Scott Gottlieb said in a press release.

The FDA will work closely with the DoD to explore how to support and promote access to safe and effective medical products to serve the military’s medical needs. The agreement also includes expedited review and attention for DoD medical products and technical advice and support of the rapid development of such products for use in the military.

The partnership builds upon an approach the FDA outlined this year looking to advance the development and availability of products intended to save the lives of American military personnel, and “reflects the agency’s commitment to working to address the medical needs of military personnel,” according to the FDA notice.

“This MOU furthers the existing partnership between the Department of Defense and the FDA to equip our military with the best and most innovative military medical support possible. Our servicemen and women risk their lives protecting our country. Today’s MOU reflects the commitment of the DoD and the FDA to ensure timely access to life-saving medical products for U.S. troops and to continue fostering the development of new innovative medical products that can help ensure the operational readiness of American troops. We look forward to continuing to work with the FDA as we analyze and implement measures to provide the best possible medical products and care to all military personnel – on the battlefield, stationed around the world and at home,” U.S. DoD Health Readiness Policy & Oversight Acting division Deputy Assistant Secretary of Defense Terry Rauch said in a prepared statement.

In July, the FDA said that it granted an emergency use authorization to the US Department of Defense for the use of particular freeze-dried plasma products designed for the treatment of hemorrhage or coagulopathy.

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