Penumbra VR device wins FDA clearance

penumbra-logoPenumbra recently announced that it has received FDA 510(k) clearance for its Real Immersive virtual reality system.

The Real Immersive System is an immersive virtual reality and display system that tracks upper extremity rehabilitation exercises for adults who have symptoms related to acute pain, cerebral palsy, stroke, orthopedic or neurodegenerative diseases. The exercise routines with the Real Immersive System are designed to be done in a seated position in a clinical environment, according to Penumbra.

The system features a clinician tablet, head-mounted display component, small sensors, large sensor, sensor charger, router, router battery, HMD controller, power cords and USB cables. The small and large sensors have mechanical and electrical components that can measure motion and direction in the physical space and then translate that information into a virtual environment.

FDA approves Intact Vascular’s Tack dissection repair device

Intact VascularThe FDA last week granted pre-market approval to the Tack endovascular repair device developed by Intact Vascular.

The Wayne, Pa.-based company’s Tack system is designed to repair dissection complications during balloon angioplasty for peripheral artery disease. Intact said the federal safety watchdog based the April 11 PMA decision on the results of a pivotal, 213-patient single-arm trial that met both its safety and efficacy endpoints. The Tack device won CE Mark approval in the European Union in January 2017.

The Toba II study‘s rate of freedom from clinically-driven target lesion revascularization, amputation or all-cause death, its primary safety endpoint, was 86.5%. The trial met its efficacy endpoint with a 79.3% primary patency rate at 12 months. And 92.1% of all dissections were completely resolved, according to results presented at last year’s Vascular InterVentional Advances conference in Las Vegas by principal investigator Dr. William Gray.

Intact Vascular said the trial, which it touted as the first to enroll PAD patients with 100% dissected vessels, also showed 0.5% bailout stent rate and zero implant fractures.

“FDA approval of the Tack endovascular system comes at a dynamic time in the PAD market place. The Tack system’s unique combination of minimal metal and highly targeted dissection repair is an ideal fit with today’s focus on minimizing inflammation and improving long term outcomes,” president & CEO Bruce Shook said in prepared remarks. “Now with the Tack endovascular system available in both Europe and the United States, we look forward to expanding our commercialization efforts and continuing to improve the quality of life for PAD patients.”

“I look forward to having the Tack implant available for my patients,” added Gray, of Wynnewood, Pa.’s Lankenau Heart Institute. “Post-angioplasty dissections can significantly impact patient outcomes. Having a minimal metal solution that specifically addresses dissections and improves angioplasty results while preserving future treatment options is extremely exciting.”

Intact said it’s planning a limited U.S. release “that will progress toward broader market commercialization.” The company raised a $20 million Series C round in April 2018.

FDA clears Gelesis weight-loss hydrogel pill Plenity



[Image from Gelesis]

Gelesis (Boston) recently announced that it has received FDA clearance for its Plenity weight management prescription drug.

The drug is a weight management aid for adults who have a body mass index of 25-40 kg/m2 and is supposed to be used with diet and exercise. It can be used in people with and without comorbidities like hypertension, type 2 diabetes or dyslipidemia. The company says that there is no restriction on how long the drug can be used in weight management.

“This FDA clearance is a major milestone for the Gelesis team and our technology, and we are thrilled to be able to bring this new prescription product to the millions of people looking for a safe, validated and convenient treatment option to manage their weight without surgery or stimulants,” Yishai Zohar, founder and CEO of Gelesis, said in a press release. “With Plenity, Gelesis is introducing a completely new approach with a unique mechanism of action to aid in weight management, with efficacy and safety supported by positive data from large clinical studies.”

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

FDA clears moldable OssiMend bioactive bone graft from Collagen Matrix

Collagen Matrix

Collagen Matrix said today that it won FDA 510(k) clearance for its line of OssiMend Bioactive Moldable bone graft matrix products, intended for use in spinal procedures.

The Oakland, N.J.-based company said that the newly cleared OssiMend product is composed of anorganic carbonate apatite bone mineral, 45S5 bioactive glass and highly purified Type I collagen, and that it can be molded into putty for filling irregular defect sites.

The moldable Ossimend product is designed to be slowly resorbed and replaced by new bone tissue, and comes in various sizes, Collagen Matrix said.

“We continue to expand our product portfolio for the Spine market with the development of this unique line of Bioactive bone graft matrices that combines a carefully-selected ratio of three powerful components. This innovative moldable version offers surgeons options for better ensuring predictable outcomes,” CEO Bart Doedens said in a press release.

FDA: Duodenoscope reprocessing is dirtier than we thought

Superbug endoscopeThe FDA said today that new data show that the contamination rate for “high-concern organisms” in duodenoscopes is nearly twice as high as previously thought and warned the devices three major manufacturers to get their required post-market studies in gear.

Back in 2015 the federal safety watchdog warned Olympus (TYO:7733), Fujifilm Holdings (TSE:4901) and Hoya’s (TYO:7741) Pentax subsidiary following a string of deadly “superbug” infections attributed to their duodenoscopes. The FDA ordered the companies to run post-market surveillance studies to assess the effectiveness of reprocessing the scopes; last year it sent the trio another set of warning letters over their failure to comply with that order.

Today Dr. Jeffrey Shuren, director of the FDA’s Center for Devices & Radiological Health, warned of possible “additional action” if the companies don’t meet their deadlines.

“While the firms have made some progress toward completing these studies, they are still not in compliance with the timetable they agreed upon to complete these studies. If the companies continue to fail to adequately respond to our concerns, the FDA will take additional action,” Shuren said in prepared remarks.

Although the number of adverse event reports for the devices fell 62%, from 250 in 2015 to fewer than 100 in 2017, a spate of 205 reports from last October to the end of March included 45 patient infections, one patient exposure and 159 contaminated devices; there were three U.S. deaths reported last year from duodenoscope infections, according to the FDA.

And as of last December the FDA thought that the contamination rate for high-concern bugs like E. coli and Pseudomonas aeruginosa was 3%. New data show that number to be more like 5.4%, the agency said.

“Let me be clear, the percent of contaminated samples based on these interim results shows that improvements are necessary and we are committed to taking additional steps to reduce infections and contamination even further,” Shuren said, noting that the FDA is considering whether more stringent action is necessary to get infection rates under 1%.

“For example, we are exploring whether supplemental measures, such as sterilization, in addition to meticulous cleaning, might offer a more effective option. This will take careful consideration because we know some sterilization methods could damage the duodenoscope over time and lead to a shorter lifespan for the expensive device,” he said.

The FDA is also consulting the Centers for Disease Control & Prevention and other health agencies “to obtain their input and guidance on the issue of infection control and reprocessing of these difficult-to-clean scopes,” Shuren said.

Elucent Medical wins FDA nod for EnVisio breast surgery navigation device

Elucent Medical

Elucent Medical said today that it won FDA 510(k) clearance for its EnVisio surgical navigation system.

The Eden Prairie, Minn.-based company said that the EnVisio navigation system is designed for use in conjunction with the company’s SmartClip soft tissue marker during breast cancer procedures.

The SmartClip soft tissue marker is an alternative to hook-wire localization procedures used to identify malignant tissue for removal, the company said. When used with the Envisio system allows physicians to mark difficult lesions and navigate distances, depths and directions in real-time 3D during breast cancer procedures.

“Elucent Medical is offering a cost-effective solution that addresses a key challenge for breast surgeons: how to easily find the location of a malignant biopsy during surgery, especially in tissue that lacks anatomical landmarks. We developed a system designed by surgeons to be intuitive, efficient, and precise, eliminating the need for a localization procedure. We believe this innovation has the potential to improve cosmetic and clinical outcomes, with other possible applications for lymph and thoracic surgeries,” co-founder Dr. Lee Wilke said in a press release.

“Our vision is to disrupt the standard of care for women who receive localization prior to their lumpectomy as part of their breast cancer treatment. Today we take a significant step toward achieving this goal. The EnVisio Navigation System and SmartClip Soft Tissue Markers will provide patients and surgeons with a wire-free, minimally invasive alternative for pre-surgical planning and navigation throughout surgery,” co-founder and CEO Laura King said in a prepared statement.

Helius Medical shares tank on FDA denial

Helius MedicalShares in Helius Medical Technologies (NSDQ:HSDT) tanked yesterday after the company said the FDA shot down its clearance bid for the portable neuromodulation device it developed.

The Newtown, Pa.-based company’s PONS system is designed to treat neurological symptoms through electrical stimulation of nerves in the tongue. A trial of the PONS device in treating patients with chronic balance deficits from traumatic brain injuries failed to meet its efficacy endpoint in November 2017. Helius said the control group showed a significant therapeutic effect from the low-frequency pulse treatment used in that arm, skewing the study into missing the effectiveness endpoint.

Yesterday the company said that the FDA denied its application for de novo 510(k) clearance, saying the the federal safety watchdog “did not have sufficient information” to determine whether PONS treatment is better than physical therapy, based on the studies Helius used to back the application.

“We are understandably disappointed by the agency’s decision to decline our request for de novo classification and 510(k) clearance, but Helius remains committed to generating the data to pursue a de novo classification and 510(k) clearance of our PONS device in the future,” CEO Philippe Deschamps said in prepared remarks. “In addition to working on generating this new data, we will continue to focus on expanding our commercial efforts and treating patients in Canada, where we do currently have regulatory clearance.”

The news sent HSDT shares down -66.2% to a $2.10-per share close yesterday; the stock opened at $2.06 today and was off -15.2% to $1.78 apiece as of 10 a.m. Eastern.

Bedfont wins FDA nod for ToxCO carbon monoxide monitor


British medical device firm Bedfont said today that it won FDA 510(k) clearance for its ToxCO breath analysis monitor designed to measure exhaled carbon monoxide to indicate levels of CO in the blood.

The newly cleared system is intended for use in triaging cases of CO poisoning as it provides instant results at the point-of-care, the Maidstone, UK-based company said.

Samples can be taken via a low-cost mouth piece or a face mask option for patients who are either unconscious or injured, the company said. The system also automatically samples the ambient air and alarms when CO in the environment reaches a harmful level.

“Not only can our breath analysis monitor help to evaluate patients quickly and effectively for CO poisoning, but it can also reduce emergency department visits and hospitalizations. We are thrilled with the FDA approval of the ToxCO; we believe it will be game-changer for healthcare personnel in America,” managing director Jason Smith said in a press release.

Bedfont said that it has already inked an exclusive U.S. distribution deal with CoVita.

“The ToxCO will be a useful tool for healthcare professionals such as paramedics in Firefighter Rehab. We believe it will fundamentally change how people are assessed for CO poisoning in the United States,” CoVita prez Jason Aversano said in a prepared statement.

Australia’s TGA considering, but not yet implementing, textured breast implant ban

Australia's TGA

Australia’s TGA said yesterday that it is seeking new data from suppliers of textured breast implants, which have been linked to a rare immune-system cancer, before making a decision on whether or not to suspend or cancel those products from its Register of Therapeutic Goods.

The regulatory body gave suppliers of the devices 10 working days to respond to the requests for more information, including dates they began to supply the devices and samples of the implants, according to a TGA release.

The decision comes after the convening of a breast implant expert panel on April 8, following recent decisions made in Canada and France to remove select implants from the market.

The implants have been linked to breast implant-associated anapestic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma.

The TGA said that the panel it convened discussed current data on the implants associated with BIA-ALCL and identified gap in the data that affected estimation of the true rate of the cancer in the country.

The regulatory body said that as of April 8, it has received 76 reports of BIA-ALCL in Australian women. The agency said that there are approximately 13,000 to 17,000 breast implant procedures performed in the country each year.

The panel also discussed the benefits of textured implants, particularly for reconstructive new surgery, and made suggestions including a need to update the TGA’s website with risks and benefits and to better encourage use of the Australian Breast Device Registry.

The TGA said that like the FDA and many other regulatory bodies, it has been monitoring BIA-ALCL cases since 2011, adding that the first adverse event report it received related to the cancer came in in 2009.

The agency said that textured implants of varying roughness are used in 82% of operations in the country.

Last month, a panel of experts convened by the FDA said that there’s not enough data to pull textured breast implants from the market over concerns that they may be linked to a type of immune system cancer.

Health Canada notifies Allergan on intent to suspend Biocell breast implant license

Allergan - updated logo

Health Canada said yesterday that it plans to suspend Allergan‘s (NYSE: AGN) licenses to sell its Biocell breast implants in the region due to a possible association with a rare immune system-cancer.

The move follows the agency’s completion of a scientific assessment of macro-textured implants, which it said is part of a larger safety review of breast implants and their association with breast implant-associated anapestic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma.

Health Canada said it launched the review last November due to an increase in Canadian and international cases of BIA-ALCL, adding that it has been notified of 28 confirmed cases. A total 86% of those, or 24, involved Allergan’s Biocell breast implant, the agency said.

The agency said that it would provide Allergan 15 calendar days to present new evidence, and that if a satisfactory response is not received by then, “it is Health Canada’s intention that the Biocell medical device licenses will be suspended.”

Health Canada said that it continues to monitor and review scientific data on the safety of the implants, and that it is engaging with other regulatory bodies globally including the FDA and France’s National Agency for Medicines and Health Products.

The agency said that it plans to provide a full safety review of breast implants and BIA-ALCL by the end of April, and that it will “not hesitate to take further action, as necessary.”

In addition, the watchdog said that it has begun a second safety review of systemic symptoms associated with breast implants, which it plans to make public this summer.

Last December, Allergan said that it removed its textured breast implants from the market in Europe following a recall request from French regulators.

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