V-Wave, Ltd., recently announced that it received the prized FDA Breakthrough Designation for its heart failure shunt. Breakthrough designation is one of the highly sought pre-approval stamps that the FDA can place on a device.
According to the FDA’s website, it is granted when the device “provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions” (than what is currently available). The program aims to provide patients and health care providers with more timely access to medical devices “by speeding up their development, assessment and review,” including prioritized review all the way through to market approval.
V-Wave’s minimally-invasive implanted interatrial shunt for the treatment of patients with severe symptomatic heart failure is designed to regulate left atrial pressure, the primary cause of breathing difficulty and hospitalization due to worsening heart failure.
“In addition to validation of the potential impact of this technology, breakthrough status will facilitate a timely regulatory review and solve a major issue with medical device investments, namely that reimbursement will effectively be secured immediately upon approval,” said Deerfielder, Andrew ElBardissi, MD, who serves on the Company’s board of directors.
The shunt is currently being evaluated in a global, randomized, controlled, double-blinded, 500 patient pivotal Investigational Device Exemption trial called RELIEVE-HF. The study is enrolling advanced heart failure patients with preserved or reduced left ventricular ejection fraction who
remain symptomatic despite the use of guideline directed medical and device therapies.
An ejection fraction is an important measurement of how well the heart is pumping and is used to help classify heart failure and guide treatment. In a healthy heart, the ejection fraction is 50 percent or higher – meaning that more than half of the blood that fills the ventricle is pumped out with each beat.
According to the Centers for Disease Control and Prevention, nearly 6 million adults in the United States have heart failure and about half of these individuals die within 5 years of diagnosis. Heart failure costs the nation an estimated $30.7 billion each year.
Achieving this status means that the device also met at least one of the following FDA criteria:
- It represents breakthrough technology;
- No approved or cleared alternatives exist;
- It offers significant advantages over existing approved or cleared alternatives; and
- Availability of this device is in the best interest of patients.
V-Wave, Ltd., a privately held medical device company, has been a Deerfield portfolio company since 2018.
Adapted from company news release: V-WAVE’S INTERATRIAL SHUNT RECEIVES FDA BREAKTHROUGH DEVICE DESIGNATION FOR HEART FAILURE: