eNews March 23, 2021

The latest news affecting you and your customers… from the Independent Medical Specialty Dealers Association

How is COVID-19 affecting your business, your people, your customers? IMDA is a membership organization, and in times like these, we can all use some camaraderie. If you have a COVID story to share, advice to offer, or a warning to sound, send it to Mark Thill, IMDA’s communications director, at mdthill1913@gmail.com, with the subject line “IMDA COVID story.” We’ll compile them and send them back out to you.

Three magical words: Real world evidence

As far as the FDA is concerned, real-world evidence is golden! It refers to proof of a new device’s effectiveness as demonstrated by things like electronic health records, registries, administrative claims, pharmacy data and feedback from wearables and mobile technology — in other words, anything other than the drawing board or research lab. The U.S. FDA’s Center for Devices and Radiological Health has published a set of 90 examples of submissions that illustrate how real world evidence played a role in bringing to market a scalp cooling system, spinal posterior ratcheting rod system, autonomic nerve stimulator, total ankle replacement system, transcatheter heart valve, high-velocity nasal insufflation device for neonates, and other technologies.

Quicker weaning off mechanical ventilation

Stimdia Medical, Inc., a Minneapolis firm developing technology to reduce weaning time for patients on mechanical ventilation, said its pdSTIM™ System has received Breakthrough Device designation from the FDA. The system is intended to provide clinicians a tool to address high-risk patients, including those with COVID-19, by providing minimally invasive neurostimulation to recondition the diaphragm, the primary muscle used in respiration. The company says that 40% of ICU admissions in the U.S. require mechanical ventilation with an average length of stay of 14 days and an estimated annual cost of over $27 billion, and its system should enable more rapid weaning of patients.

Last-minute delay

The feds have put on hold a rule that would have granted Medicare coverage for breakthrough devices the same day as their FDA approval, reports Medical Design & Outsourcing. The rule – which had bipartisan support — had been issued in January by the Centers for Medicare & Medicaid Services. But the delay isn’t expected to last long. Rather, it’s part of a blanket request by the Biden administration for federal agencies to consider delaying the effective date of rules so it could review questions of fact, law and policy.

Cell therapy for stroke victims

Scientists at The Ohio State University are developing a cell therapy intended to regrow brain tissue damaged from ischemic stroke, reports MedCity News. The research is early, and so far, tests have only been done in mice. But scientists have reported that the injected cells – made with skin cells and genetic material — promote the growth of healthy vascular tissue that restores blood supply. In a published paper, mice were reported to have shown an increase in blood flow, compared to a control group, measured at seven, 14, and 21 days following the injection. Furthermore, the mice that received the treatment regained 90% of their motor function. Brain scans showed signs of brain repair.

Vacant mall department store put to good use

A medical group has completed construction of a surgery center inside a former Bergner’s department store in Quincy, Illinois, reports Becker’s ASC. It is Quincy Medical Group’s second project at the location, following the opening earlier this year of a cancer institute. The surgery center spans 70,000 square feet and will offer services including endoscopy, cardiac catheterization and ophthalmology laser surgery.

Smart knee implants

Gyroscopes,, accelerometers and a pedometer – all in a knee implant. The so-called CHIRP sensor from Vancouver, British Columbia-based Canary Medical will be incorporated into Zimmer Biomet’s Persona-IQ knee implant later this year, reports Medical Design & Outsourcing. The CHIRP can measure and passively broadcast data on step count, range of motion and gait for up to 20 years, according to Canary Founder Bill Hunter. Physicians could monitor their patients, see how active they are, and measure their range of motion.