More device shortages pegged to sterilization plant shutdown

Cardinal Health’s Accu-Trace intrauterine pressure catheter (Image from Cardinal Health)

More medtech companies are experiencing shortages of medical devices due to the sudden closure in February of a Sterigenics sterilization plant.

Officials from Cardinal Health (NYSE:CAH), and Guerbet (EPA:GBT) have written letters to customers indicating that certain devices are already in short supply or may experience shortages, Medical Device & Outsourcing has learned.

The letter from Cardinal Health (Dublin, Ohio) said that the company expects a shortage of its Kendall Accu-Trace intrauterine pressure catheter until early August. This device is placed inside a pregnant woman’s uterus to monitor uterine contractions during labor. The letter from Guerbet (Villepinte, France) said that disposable power injectors used with its Optistar, Optivantage and Illumena contrast delivery systems may experience shortages. Officials from those companies did not immediately respond to requests for comment.

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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.

EO plant shutdown leads to pediatric breathing tube shortage

Smiths Medical Bivona tracheostomy tubes are in short supply, according to the FDA. (Image from Smiths Medical)

The February shutdown of an ethylene oxide (EO) sterilization plant has produced the first temporary medical device shortage, according to the FDA.

The device in short supply is the Bivona tracheostomy tube manufactured by Smiths Medical and used by many pediatric patients. The FDA anticipates the tube will be made available again the week of April 22, according to a statement from Dr. Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health (CDRH). The state of Illinois ordered the shutdown of the Sterigenics plant in Willowbrook, Ill. due to emissions of EO, a highly carcinogenic chemical compound.

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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.

FDA warns against unapproved concussion diagnosis devices

FDAThe FDA today warned consumers against using medical devices purported to assess head injuries, saying tht only five companies are cleared to market such devices in the U.S. and that they should only be used by physicians.

“The FDA has identified several manufacturers that were marketing medical devices for concussion diagnosis, treatment or management without the FDA’s approval or clearance,” the federal safety watchdog said. “To date, there are a limited number of medical devices that have been approved or cleared by the FDA to aid in diagnosis, treatment or management of head injury, including suspected concussion and other traumatic brain injuries. Additionally, the FDA has not approved or cleared any devices that can assess or diagnose a head injury, including suspected concussion and other traumatic brain injuries without an evaluation by a health care provider.”

“I want to be clear, there are currently no devices to aid in assessing concussion that should be used by consumers on their own. Using such devices can result in an incorrect diagnosis after a head injury that could lead a person with a serious injury to return to their normal activities instead of seeking critical medical care, putting them at greater danger,” added Center for Devices & Radiological Health director Dr. Jeffrey Shuren. “Products being marketed for the assessment, diagnosis, or management of a head injury, including concussion, that have not been approved or cleared by the FDA are in violation of the law. The FDA routinely monitors the medical device market and became aware of violative products being marketed to consumers. The FDA has alerted companies to our concerns and asked them to remove such claims. We will continue to monitor the marketplace for devices making these unsubstantiated claims and are prepared to take further action if necessary.”

Avinger wins FDA nod for Pantheris SV small vessel atherectomy device


Avinger (NSDQ:AVGR) said today that it won FDA 510(k) clearance for its Pantheris SV small vessel image-guided atherectomy system.

The Pantheris SV is an extension of the Redwood City, Calif.-based company’s lumivascular image-guided atherectomy platform which it hopes will expand the available market for its Pantheris devices by up to 50%.

The newly cleared device features a lower profile and longer length than the standard Pantheris, and is indicated for diagnosing and treating peripheral artery disease in small vessels between 2mm and 4mm.

“We are excited to receive U.S. pre-marketing clearance for Pantheris SV, which we believe could expand our addressable market for atherectomy procedures by as much as 50%. With the clearance of this new device, we are well-positioned to build on the positive momentum we have seen in our Pantheris business since the introduction of the next-generation system in 2018. Following our anticipated limited launch of Pantheris SV, we plan on leveraging our growing commercial infrastructure and installed base of Lumivascular accounts to efficiently scale up the introduction of Pantheris SV and drive growth of our Pantheris product family in the second half of 2019,” prez & CEO Jeff Soinski said in a press release.

The company said that it is planning to initiate a limited launch of the Pantheris SV at several U.S. sites, and that it expects distribution to expand as it builds product inventory and gains additional clinical experience.

“This product line extension represents a significant advancement for patients with PAD, in particular those suffering from the complications of small vessel disease. Treating small vessels presents a number of challenges and physicians have had a limited set of minimally invasive tools that can provide safe and effective outcomes for this high-risk patient population. Pantheris SV uses a combination of directional atherectomy with onboard image-guidance to provide several potential clinical advantages, including an enhanced safety profile, the ability to maximize luminal gain without causing vascular injury, and precise vessel measurement capabilities,” chief medical officer Dr. Jaafer Golzar said in a preapred statement.

Avinger said that the Pantheris SV won CE Mark approval in the European Union last October. The company submitted an FDA application for approval for the Pantheris SV last August.