Sunshine Heart’s cardiac medical device, the C-Pulse, has shown promise in a clinical trial, and the company plans to apply for pre-market approval sometime in the fourth quarter.
The C-Pulse system uses balloon counter-pulsation technology to reduce the workload of the heart’s left ventricle, relieving heart failure symptoms. The product is similar to a pacemaker in that the balloon inflation and deflation synchronizes with the patient’s heartbeat.
’This is our sole product, so from our standpoint we are primarily a single medical device company and this is what we’re focused on,’ said Sunshine Heart CFO Jeff Mathiesen.
’It’s designed for Class 3 heart failure patients, and our product is really focused on halting the progress of heart failure to a later stage and providing symptomatic relief, allowing the patient to have more energy and restore the quality of life that has been impacted by heart failure up to that point and do so through a minimally invasive procedure to implant the device.’
The device, which costs $54,000, has been reimbursed in 14 out of 20 patients in the feasibility trial.
Sunshine Heart is going through the FDA approval process and hopes to successfully introduce the product into European markets in the interim through successful pivotal trials and obtaining the CE mark. The company is applying for the CE mark, which it expects to receive sometime in early 2012. If that happens in that time frame, the product could be sold in Europe toward the end of the first half of next year.
The companycompleted enrollment for a feasibility study earlier this year with topline results, and will present more detail at the Transcatheter Cardiovascular Therapeutics conference in November. The company plans to get Investigational Device Exemption approval for a pivotal trial that could start sometime next year. The entire process is expected to take just over three years. Therefore, Mathiesen does not expect commercially available devices to be sold for the next several years, up to 2016.
A million and a half people suffer from class 3 heart failure in the U.S., and the device would be suited for around 5 million people in the world. Alternatives include medical therapy and Thoratec’s HeartMate 2, a left ventricular assist device which Mathiesen says is reimbursed for class 4 heart failure patients and, though qualified for class 3B patients, is not reimbursed for class 3B. The C-Pulse system has a lower risk profile, so Mathiesen believes it is designed for a fairly large unaddressed market.