Breakthrough device status for interatrial shuntOctober 8, 2019
The US FDA has granted a Breakthrough Device Designation for its interatrial shunt for heart failure (HF), said V-Wave Ltd.
The 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 HF patients with preserved or reduced left ventricular ejection fraction who remain symptomatic despite the use of guideline-directed medical and device therapies.
More than 6 million people suffer from chronic heart failure in the US. 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, said CEO Neal Eigler, MD in a statement.