V-Wave said today that the FDA has granted breakthrough device designation for its interatrial shunt for heart failure (HF).
The Caesarea, Israel-based company’s minimally invasive, implanted 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 heart failure patients with preserved or reduced left ventricular ejection fraction who remain symptomatic despite the use of guideline-directed medical and device therapies.
“This FDA breakthrough device designation emphasizes the critical and unmet need for novel therapeutic devices for HF,” said heart failure cardiologist and V-Wave chief medical officer Dr. William T. Abraham in a news release. “More than 6 million people suffer from chronic heart failure in the U.S. HF remains a leading cause of acute hospitalization in the Medicare age group. Despite decades of advances in therapy, heart failure patients continue to deteriorate, enduring disabling symptoms, having a poor quality of life, diminished exercise tolerance, and a markedly reduced life expectancy. The V-Wave shunt relieves excessive pressure in the left side of the heart, thereby reducing the build-up of fluid in the lungs, which is known to be the most common reason for HF hospitalizations and exercise limitation.”
“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.A.,” added V-Wave CEO Dr. Neal Eigler. “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 (Medicare) support for this program makes our breakthrough designation a double-win for HF patients who need access to novel therapies as quickly as possible.”