Less than two weeks ago we covered the news that Sunshine® Heart Inc.’s C-Pulse® Heart Assist system had gained CE mark clearance. Now the company has announced that FDA has given it the nod to incorporate an upgraded component in its device which is currently being used on an investigational basis in the United States.
Sunshine Heart, according to an item published by Reuters, has become something of a darling of the specialist investor community with a doubling of its share price in recent weeks. Now that the company has announced FDA’s favourable attitude towards its upgrade, no doubt further bolstered by the CE marking announcement, the share price has made further gains with a 12% premarket leap.
C-Pulse is unquestionably a clever short term alternative or at least delay to the requirement for a more invasive heart assist device. It takes the form of a wrap-around cuff, sitting at the aortic arch root and works by inducing a counterpulse after ventricular contraction. This compresses the aorta, so improving circulation to the coronary arteries, while also assisting ventricular ejection with a secondary “squeeze”, so improving blood flow to the body.
The upgraded part is lighter, quieter and about half the size of its predecessor and also features a number of software enhancements. The company says it will be incorporated upon receipt of confirmed approval, the current nod being passed to an independent committee for sign-off.
Source: Sunshine Heart Inc., Reuters