Sunshine Heart (ASX:SHC) won conditional approval from the FDA for the next generation of its flagship C-Pulse heart assist system, an outside-the-bloodstream left ventricular assist device that helps circulate blood and reduce the pumping burden on a patient’s heart.
The new model aims to provide "enhanced patient comfort and performance," featuring a lighter, quieter, smaller unit with a number of software enhancements, according to a press release.
The FDA granted the device investigational approval for use during clinical trials, and Sunshine Heart plans to make the new system available to all patients currently on the older model, according to the release.
The device maker is on a roll, having won CE Mark approval in the European Union late last month, news that drove SHC shares up 14% in one day. Shares jumped again today, trading 10.7% higher at $9.38 as of about 2 p.m.
The Eden Prairie, Minn., and Sydney-based medical device company said the new FDA approval clears the device for investigational treatment of Class III and Class IV heart failure patients, as does the C-Pulse system’s European approval.
Rosa told MassDevice.com in April that the U.S. market alone offers 1.5 million Class III patients. In Europe, that number is 3.7 million, according to Sunshine Heart.
Unlike traditional left ventricular assist devices, Sunshine Heart’s implantable "counterpulsation" C-Pulse device delivers pumping help from outside of the heart. Because the device has no contact with the blood, patients can reduce or in some cases eliminate their reliance on blood-thinning drugs.
Listen to MassDevice.com’s podcast interview with Sunshine Heart CEO David Rosa
It also means that patients can disconnect the device for short durations in order to shower, drive a car or engage in other activities that heart failure device patients are generally cautioned against.
In the last year, Sunshine Heart completed a feasibility trial for its fully implantable C-Pulse system, completed 5 research & development programs and began listing SSH shares on the NASDAQ stock exchange.