Cardiovascular medical device maker CircuLite won conditional FDA approval for its flagship device, the Synergy circulatory support system. The company claims that this device, roughly the size of a AA battery, is the world’s smallest implantable heart pump.
The federal watchdog agency has granted conditional approval for Investigational Device Exemption (IDE) status. Synergy is an implanted device meant to halt symptoms for chronic heart patients by improving blood flow during a heart failure.
CircuLite is currently designing a 20-patient feasibility trial that will take place at 7 clinics in the U.S.
"Beginning our U.S. feasibility trial marks a significant milestone for the company, and is the first step on our path to providing a new treatment option to tens of thousands of U.S. ambulatory chronic heart failure patients who have no other options today," CircuLite CEO Paul Southworth said in prepared remarks.