Sunshine Heart's ($SSH) painless trip through the regulatory world continues, as the FDA conditionally approved its C-Pulse Heart Assist System, giving the company a green light to start a pivotal trial.
Now, Sunshine Heart plans to spend the next 2 1/2 years enrolling 388 patients in a multi-center study, gathering data to go back to the FDA for a full approval for C-Pulse. So far, everything has gone according to plan for Sunshine Heart, and CEO Dave Rosa said that's a testament to the strength of its device.
"I am especially pleased that we were able to receive this approval on our initial submission," Rosa said in a statement. "The company has achieved its regulatory and clinical objectives by receiving both the CE Mark and U.S. IDE approval this year. These timely approvals continue to support the company's market guidance and timelines."
The device is designed to treat moderate to severe heart failure, boosting patient comfort and performance through its outside-the-bloodstream ventricular assistance. Part of the tech's novelty is that it requires little or no use of blood-thinning drugs such as warfarin, cutting back on many of the risks associated with similar devices.
Large-scale IDE trials are expensive propositions, of course, and Sunshine Heart pulled in $18 million in its August IPO to help cover the cost. The company also expects to get some revenue from the participating clinics, anticipating CMS and private insurance reimbursement for the trial centers.
- read Sunshine Heart's release