Dive Brief:

• FDA has granted breakthrough device designation to a transcatheter aortic valve replacement system in development at JenaValve Technology, the company said Thursday.

• JenaValve is working to fill an unoccupied niche in the fast-growing TAVR market by winning approval for its system in patients with severe aortic regurgitation (AR) and AR-dominant mixed aortic valve disease at high risk for surgery.

• The news was part of a flurry of breakthrough device notices this week, when 3Derm Systems, KDx Diagnostics and Reflow Medical also revealed they have received the FDA designation.

Dive Insight:

TAVR has emerged as one of the hottest subsections of the medical device industry in recent years, with Edwards Lifesciences, Medtronic and Boston Scientific competing to change the treatment paradigm for heart valve disease. Edwards and Medtronic have devices approved by FDA for use in patients with severe aortic stenosis ​at low risk for major complications with open heart surgery. Boston Scientific, newer to the U.S. market, so far is only approved in patients with severe aortic stenosis who are at high risk with open heart surgery.

Conversely, JenaValve is looking to address the population with severe AR and AR-dominant mixed aortic valve disease who are at high risk for surgery. Last year, JenaValve presented 30-day data from a feasibility study of its TAVR system. All 12 patients survived and paravalvular leakage was minimal. Most patients improved on a heart failure scale.

JenaValve is using the data as a springboard for its long-running attempt to bring a TAVR device to the U.S. market. Work on JenaValve began in the 1990s and an earlier version of the device secured a CE mark. JenaValve has since redesigned the device, switching from transapical to transfemoral delivery.

Buoyed by the data to date, JenaValve plans to seek U.S. humanitarian device exemption in the second half of the year. In parallel, JenaValve will continue to enroll patients in a clinical trial designed to generate the data needed to win premarket approval. The breakthrough designation may aid these efforts by positioning JenaValve to receive extra input from FDA and an expedited review. 

JenaValve raised almost $14.5 million last year to fund the work. The financing added to the more than $100 million raised by JenaValve to date, most notably through a $72.5 million Series C financing round that attracted support of investors including Edmond de Rothschild Investment Partners and Atlas Venture Fund.

The news was sandwiched between a clutch of other breakthrough device notifications. On Tuesday, 3Derm said FDA had granted the designation to an algorithm designed to detect melanoma, squamous cell carcinoma and basal cell carcinoma in skin images. The next day, KDx said its urine-based bladder cancer test had received FDA breakthrough designation.

Reflow released the last in the recent series of statements about breakthrough designations. The cardiovascular disease specialist picked up breakthrough status for a retrievable stent designed for use in below-the-knee peripheral artery disease.