Drug-coated balloons have emerged as one of the next major product segments within interventional cardiology, particularly for the treatment of peripheral arterial disease, but they appear to have hit their first major bump in the road. In November, Medtronic notified clinicians that it was recalling and discontinuing sales of its In.Pact Amphirion DCB for below-the-knee revascularization in patients with critical limb ischemia, based on forthcoming data from the company’s IN.PACT DEEP clinical study.
Breathe Technologies is bringing a bit of disruption to the staid ventilator market: NIOV, a portable ventilator, can help patients breathe easier both inside and outside the hospital. But perhaps because innovation in this field isn’t common, the company is meeting resistance from some payors, most notably the Centers for Medicare and Medicaid Services, which doesn’t see the device as a ventilator but rather another form of oxygen therapy.
CDRH Director Jeffrey Shuren discussed the device center’s two-year strategic priorities with “The Gray Sheet.” The center plans to rebalance pre-market and post-market data collection, when appropriate, and improve the processes for starting up clinical trials in the U.S.
Starting as the first company with a device therapy for resistant hypertension, CVRx was soon competing with the renal denervation avalanche, along with trying to survive the economic collapse and a failed trial. Fortunately, the company had gotten its funding when the getting was good.
After emerging from the DOJ settlements, the leading pure-play orthopedics company is emphasizing – and redefining – innovation to drive growth. Zimmer CEO David Dvorak talks to IN VIVO about his company’s commitment to innovation, and how the very notion of innovation is changing.
Medtronic’s subdued showing at NASS in October revealed the sometimes rocky relationship among industry, clinicians, and academia: The Yale University Open Data Access Project suggested rhBMP-2 didn’t fuse bone any better than standard-iliac crest bone graft, yet Medtronic executives found some vindication in the process, saying it supported on-label use of BMP, and suggested the Yale University-led process could be a model to settle future controversies in the medical industry.
In an interview with “The Gray Sheet,” CDRH Office of Compliance Director Steven Silverman detailed upcoming pilot programs designed to translate his recent focus on agency-company collaborations into action.
The first fully functional artificial pancreas for patients with diabetes could be ready for regulatory submission in the next few years. Medtronic has achieved notable success in this area to date, but positive clinical studies have put J&J in a good position as well, and the medical community is watching closely as the major developments in this groundbreaking endeavor continue to move forward.