eNews March 16, 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.

Surgical robots to watch

Intuitive Surgical pioneered robotic surgery through the early 2000s and remains the dominant player, but many other companies have entered the market, including big ones (e.g., Medtronic, Stryker, Johnson & Johnson, Zimmer Biomet, Smith+Nephew) and some smaller ones (Asensus Surgical, Titan Medical, Vicarious Surgical.) Read about the race to the top in Medical Design & Outsourcing.

Remote neuromodulation

Abbott reports that the FDA approved its neuromodulation treatment platform that allows physicians to communicate with patients and monitor or change their treatment remotely. The NeuroSphere Virtual Clinic provides an in-app video chat and integrated remote programming feature compatible with Abbott’s Infinity deep-brain stimulation system, Proclaim XR spinal-cord stimulation system, and Proclaim dorsal root ganglion neurostimulation system. Neuromodulation works by delivering electrical treatment directly to a targeted area to alter nerve activity.

Not so fast!

Physicians writing in The England Journal of Medicine have called for the Centers for Medicare & Medicaid Services to shelve its plan to reimburse providers using breakthrough devices as soon as such devices are cleared for marketing by the FDA, reports MedTech Dive. “By circumventing existing, evidence-based processes for Medicare-coverage decisions, the rule could fuel the use of devices by beneficiaries without rigorous evidence supporting safety and effectiveness,” they wrote. CMS mandates postmarketing studies to fill in gaps in the premarket evidence on breakthrough devices. However, the Medicare Coverage of Innovative Technology program would enable companies to access Medicare beneficiaries before the completion of postmarketing studies.

Hip replacement software

Cuptimize Inc., a Florida-based medical device software company focused on spinopelvic motion abnormalities, received FDA clearance for its latest software that provides a preoperative and intraoperative solution that relies exclusively on X-ray and requires no CT scan for the preoperative analysis module. The system allows hip surgeons to understand when the patient has a problem, determine cup placement to mitigate risk and have clear indications of when to use dual mobility implants. The system also integrates directly with intraoperative navigation solutions.

Medicare advances EMS program

CMS announced the final list of participants approved to take part in the agency’s Emergency Triage, Treat, and Transport (ET3) Model, which aims to provide greater flexibility to ambulance care teams addressing the emergency needs of Medicare fee-for-service beneficiaries. Historically, Medicare has only paid for emergency ground ambulance services when beneficiaries are transported to specific types of facilities, most often a hospital emergency department. The voluntary, five-year payment model requires participating ambulance suppliers and providers to collaborate with alternative destinations, such as primary care doctors’ offices or urgent-care clinics, and with qualified healthcare practitioners to deliver treatment in place, which can be on-the-scene or through telehealth.

Near-cure for heart failure?

Switzerland-based Berlin Heals announced that the FDA granted a Breakthrough Device Designation for its Cardiac Microcurrent Therapy (“C-MIC”), an implantable device that delivers a constant but minimal electrical DC-current to the heart via two electrodes. Based on results of first-in-human studies in 2019/20, the C-MIC device has shown potential to become the first near-curative heart failure therapy, according to the company. The FDA’s Breakthrough Devices program accelerates the development of medical devices with the potential to effectively treat or diagnose life-threatening or irreversibly debilitating diseases. Heart failure is a chronic inflammatory disorder responsible for 16% of all deaths worldwide, according to the company. It has shown the largest increase among all fatal diseases since 2000, rising by more than 2 million to 8.9 million deaths in 2019.

Thrombectomy catheter safeguards vessel walls

Galway, Ireland-based Vetex Medical announced it received FDA 510(k) clearance for its ReVene® thrombectomy catheter, designed to de-clot peripheral vessels, such as in deep vein thrombosis, in a single session without the use of thrombolytics. A dynamic cage separates clot from vessel walls through wall-to-wall contact, while a catheter simultaneously draws clot into the device, where it is macerated and transported out of the body. The device is said to safeguard vessel walls and valves by self-adapting to vessel size and physiology. The clot is continuously extracted during the procedure, minimizing the number of device passes and creating procedural efficiencies. The single-use device is expected to be commercially available in the U.S. later in the year.