V-Wave's Interatrial Shunt Receives FDA Breakthrough Device Designation for Heart Failure
August 15, 2019—V-Wave Ltd., a privately held Israel-based company developing novel implantable interatrial shunt devices, announced that the FDA has granted Breakthrough Device designation for its interatrial shunt for heart failure.
V-Wave's minimally invasive, implanted interatrial shunt is being evaluated in the pivotal RELIEVE-HF investigational device exemption trial. The global, randomized, controlled, double-blinded study. It is enrolling 500 patients who have advanced heart failure with preserved or reduced left ventricular ejection fraction who remain symptomatic despite the use of guideline-directed medical and device therapies.
The V-Wave interatrial shunt system is under clinical investigation and is not available for sale in the United States or other countries, cautioned the company.
In its announcement, the company advised that the FDA's breakthrough device designation is granted to devices that have the potential to offer a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. The program aims to provide patients and health care providers with more timely access to medical devices by speeding their development, assessment, and review, including prioritized review all the way through market approval.
The company additionally noted that the Centers for Medicare & Medicaid Services has announced that it is developing a means to expedite reimbursement pathways and provide increased payments for medical devices designated as a breakthrough.