Sunshine Heart (SSH) Receives Conditional FDA Approval for IDE of C-Pulse Heart Assist System

October 1, 2012 8:50 AM EDT
Sunshine Heart, Inc. (Nasdaq: SSH) has received conditional approval from the FDA for an Investigational Device Exemption (IDE) for its flagship C-Pulse Heart Assist System.

With the receipt of conditional approval of the IDE, Sunshine Heart plans to initiate a pivotal trial in North America in the fourth quarter of 2012. The trial design will consist of 388-patients of which half will be implanted with the C-Pulse System. The other half will be randomized to optimal medical therapy across 30-40 clinical sites. Sunshine Heart expects to receive revenues from trial sites for device implants as the FDA has granted CMS Category B3 status. Because of this designation, it is also anticipated that participating trial centers will be reimbursed by CMS and most private insurance providers. The trial will utilize the Company'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 currently on the device. The new driver features a single unit, which is lighter, quieter, approximately half the size of its predecessor, and also includes numerous software updates.

The Company estimates enrollment for the event-driven trial will take approximately 2.5 years. The primary endpoint of the trial will be reduction in worsening heart failure events leading to hospitalization, advanced heart failure therapies and heart failure related mortality. A one year safety follow-up is expected. The lead investigator for the trial will be Dr. William T. Abraham, Director of the Division of Cardiovascular Medicine at The Ohio State University Medical Center.

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