V-Wave has received a breakthrough device designation from the FDA for its interatrial shunt being tested for heart failure.
Implanted through a minimally invasive procedure, the biocompatible device creates a passageway connecting the heart’s two atria. By allowing excess blood to flow between the chambers, the shunt is designed to help regulate high pressure in the left atrium, which can lead to the buildup of fluid in the lungs and difficulty breathing.
Currently, V-Wave’s device is being evaluated in a randomized trial set to enroll 500 patients with advanced heart failure that are still symptomatic following other drug and device therapies, including patients with preserved or reduced left ventricular ejection fraction. The study is expected to return data in late 2021.
In addition to the extra face time with federal regulators that the FDA designation affords during development and prioritized review, the Centers for Medicare and Medicaid Services recently finalized ways to expedite reimbursement for breakthrough products following approval.
“The potential for early CMS 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,” V-Wave CEO Neal Eigler said in a statement.
The Israel-based V-Wave raised $70 million for its efforts last year, in a series C round led by Deerfield Management. Its previous backers also include Johnson & Johnson Innovation and Edwards Lifesciences.
"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,” said William Abraham, V-Wave’s chief medical officer.
“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,” Abraham said, pointing to fluid buildup in the lungs as one of the most common reasons for heart failure hospitalizations.