(MENAFN - ProactiveInvestors - Australia) Sunshine Heart (ASX: SHC, NASDAQ: SSH) has received conditional approval from the U.S. Food and Drug Administration for an Investigational Device Exemption (IDE) for its flagship C-Pulse Heart Assist System.
This paves the way for a pivotal trial in North America in the December quarter of 2012.
The company has achieved its regulatory and clinical objectives by receiving both the CE Mark and U.S. IDE approval this year.
Importantly, Sunshine Heart received the approval on its initial IDE application submission.
Sunshine Heart's system has a competitive advantage in that it is a minimally invasive procedure, the device is outside of the bloodstream, patients can disconnect from the system and it promotes reduced hospital stays and medications.
Trial results have successfully demonstrated improved quality of life, reduction in heart failure class, improved cardiac function, reduced hospital stay and medications, and 10% of patients no longer require therapy.
The primary endpoint of the proposed 388 patient pivotal trial is the reduction of events such as re-hospitalisation due to worsening heart failure and heart failure-related mortality.
The study will evaluate results for patients that receive the C-Pulse System in comparison to a control group that is managed on optimal medical therapy.
Sunshine Heart expects to receive revenues from trial sites for device implants as the FDA has granted CMS Category B3 status.
This designation also means that participating trial centres will be reimbursed by CMS and most private insurance providers.
The trial will utilise Sunshine Heart's next-generation C-Pulse driver, which received approval for clinical trial use from the FDA in August 2012, and has been in use in Canadian patients.
The new driver features a single unit, which is lighter, quieter, about half the size of its predecessor, and also includes numerous software updates.
With a large and growing population of C-Pulse eligible patients and hospitals facing financial penalties for high heart failure re-hospitalisation rates beginning in 2013 under the Obama Health Reform Act, the C-Pulse pivotal trial will determine if it will be beneficial to both patients and hospitals alike to improve health outcomes.
In July, Sunshine Heart announced positive 12-month extended follow up data from its preliminary feasibility study.
Also in July, the company achieved CE Mark certification, allowing commercialisation of the device in Europe.
Sunshine Heart has been targeting leading left ventricular assist device and transplant centres in Europe.
Specific initial focus for the device has been within Germany and Italy, two countries that when combined are believed to have the highest number of hospital bed days per year for heart failure in Europe.
Sunshine Heart recently completed an underwritten 20.1 million capital raising, which raised net proceeds of about 18 million after underwriting discounts and other offering expenses.
The company offered 2.87 million shares of its common stock at 7 per share to raise the cash.