V-Wave said yesterday that it won FDA breakthrough device designation for its interatrial shunt for pulmonary arterial hypertension, marking the second time in less than a month that the company has earned a breakthrough nod.
The PAH shunt is designed to be placed in the heart through a catheter inserted via a vein in the groin, to prolong the benefits found with septostomy and relieve the progressive disorder that causes high blood pressure in the pulmonary arteries and failure of the heart’s right ventricle. Caesarea, Israel-based V-Wave won breakthrough designation for heart failure Aug. 15.
V-Wave is currently testing the minimally invasive interatrial PAH shunt in a 20-patient IDE early feasibility study called Relieve-PAH, which has an estimated primary completion date of Dec. 31, 2020, and an estimated completion date of Dec. 31, 2024.
“These two distinct breakthrough designations illustrate V-Wave’s dedication to innovation and improving outcomes for two debilitating diseases – HF and PAH,” V-Wave CEO Dr. Neal Eigler said in prepared remarks. “Through the breakthrough device program, the FDA may grant sponsors earlier market approval based on intermediate and surrogate endpoints that correlate with patient improvement. Sponsors would then gather longer term, more traditional clinical endpoint data during the early post-market phase. We are thrilled to be able to work even more closely with the FDA to accelerate the introduction of potentially clinically impactful PAH therapies in the U.S. Given the small patient population and the severity of the disease, breakthrough designation may provide an opportunity for expedited access of this novel therapeutic approach to highly symptomatic and compromised PAH patients who need better treatment options as quickly as possible.”