JenaValve is showing significant progress in the plan to get its transcatheter aortic valve replacement (TAVR) system approved. FDA granted the Irvine, CA-based company Breakthrough Device Designation for the JenaValve Pericardial TAVR system.

This designation is for severe aortic regurgitation (AR) and AR-dominant mixed aortic valve disease, a life-threatening and seriously debilitating condition, in patients at high risk for surgery. The JenaValve Pericardial TAVR System consists of a bioprosthesis comprised of a self-expanding nitinol stent with a porcine pericardial valve manufactured using state-of-the-art tissue processing techniques. The TAVR System is available in three sizes to treat a broad range of aortic annulus diameters.

In a release, John Kilcoyne, JenaValve CEO, said, “We are clearly encouraged by this positive decision by the FDA regarding the expedited review of our unique TAVR system for patients suffering from severe aortic regurgitation who are at high risk for surgery and for which no transcatheter valve device is labeled or approved in the U.S. We look forward to continuing collaborative interactions with FDA as we move to finalize our clinical development program.”

Kilcoyne took over as CEO in January of 2019 after Victoria Carr-Brendel left the company in 4Q18.

The firm said it will file for U.S. humanitarian device exemption approval in the second half of this year. The company intends to continue to enroll patients in the clinical program throughout the year to support a future PMA application to FDA as part of the Breakthrough Device program.

JenaValve’s Breakthrough Device Designation marks the success of a smaller medtech company in the TAVR market. It also carries the strong momentum of the procedure experienced in 2019 into 2020.  The designation comes on the heels of a year that can only be described as one of the most transformational times in TAVR’s history.

Last year, TAVR saw a surge in popularity after Rolling Stones’s frontman Mick Jagger had undergone the procedure. The market for TAVR devices also expanded. For years, Edwards Lifesciences and Medtronic held a duopoly in the space – having approvals for devices in both Europe and the U.S. That all changed when Marlborough, MA-based Boston Scientific won a nod from FDA for the Lotus Edge.

Last Summer, FDA gave an expanded indication to both Medtronic and Edwards’s TAVR devices so the technology could be used in patients with low-risk for death or major complications associated with open-heart surgery. The nod caused analysts to say the conversation will eventually shift toward TAVR being the “preferred treatment method.” MD+DI named TAVR as one of the Medtech Winners of 2019 because of all the strides that were made in the market.