FDA and Hibernicor to have a pre-IDE meeting
28 September 2007
Hibernicor LLC will have a preliminary Investigation Device Exemption (pre-IDE) meeting with the Food and Drug Administration (FDA) to discuss the proposed regulatory pathway for the company’s heart preservation device. Dr. Andrew L. Rivard with the company members will meet representatives of FDA’s Center for Devices and Radiologic Health (CDRH) on October 5th, 2007. The company will discuss draft pre-clinical and clinical protocols as well as a proposal for a pre-clinical heart transplant study. This meeting is a preliminary FDA review intended to obtain comments to facilate the regulatory submission process. Based upon the discussions with the FDA, Hibernicor will finalize the research protocols for market clearance.
