V-Wave has announced that the FDA has granted it a second Breakthrough Device Designation—the first was for its interatrial shunt for heart failure and the second is for pulmonary arterial hypertension. The company is testing a minimally invasive, implanted interatrial shunt device for pulmonary artery hypertension in a global approved investigational device exemption (IDE) early feasibility study (RELIEVE-PAH).

William T Abraham, V-Wave chief medical officer, says: “V-Wave is testing an investigational therapeutic implantable device that is placed in the heart through a catheter inserted through a vein in the groin. The goal of the implant is to create a well-controlled, durable shunt that will yield more reliable results and prolong the benefits found with septostomy. The FDA has agreed to initial human testing of the V-Wave shunt in patients who remain severely symptomatic despite multiple medications.”

CEO Neal Eigler, states: “These two distinct breakthrough designations illustrate V-Wave’s dedication to innovation and improving outcomes for two debilitating diseases—heart failure and pulmonary arterial hypertension. Through the Breakthrough device programme, 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 pulmonary artery hypertension therapies in the USA. 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 pulmonary artery hypertension patients who need better treatment options as quickly as possible.”