August Is Hot with New FDA Breakthrough Device Designations

V-Wave is joining the growing list of companies that have been granted breakthrough device designation by FDA this month. The Caesarea, Israel-based company gained the designation for its interatrial shunt for heart failure. Miniature and minimally invasive, the interatrial shunt relieves increased left atrial pressure, which in turn, decreases fluid build-up in the lungs. “The interatrial shunt allows a small amount of blood volume from the left side of the heart to flow into the right side of the heart,” Murtaza Mogri, PhD Director, Business Development & Market Access V-Wave, told MD+DI. In a release, “V-Wave CEO Neal Eigler, MD, added, "We are thrilled to be able to work even more closely with the FDA to accelerate the introduction of potentially clinically impactful therapies in the U.S. This breakthrough designation provides V-Wave with additional options for FDA communication that will facilitate collaboration, as well as a prioritized review of submissions and marketing applications. The potential for early Centers for Medicare and Medicaid Services support for this program, makes our Breakthrough Designation a double-win for heart failure patients who need access to novel therapies as quickly as possible." Currently, the interatrial shunt is being evaluated in a global, randomized, controlled, double-blinded, 500 patient pivotal IDE trial called RELIEVE-HF. The study is enrolling advanced HF patients with pre...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Business Source Type: news