Cardiogenesis Submits IDE To FDA

Cardiogenesis has submitted an IDE (Investigational Device Exemption) to the FDA to initiate a safety and feasibility trial for its Phoenix System in patients with refractory angina. The Phoenix handpiece is specifically designed to allow physician-directed tissue stimulation and injections of biologic or pharmacologic agents to pre-determined areas of myocardium.

The Phoenix includes an integral CrystalFlex fiberoptic component consisting of thirty-seven 100µm diameter fibers, identical to the fiberoptic component currently in use in the FDA approved Sologrip III and Pearl 5.0 handpieces.

The handpiece has been modified to include three 26 gauge needles positioned around the fiberoptic fibers, which allow precise delivery of biologic/pharmacologic fluids into the tissue surrounding the channels created by the fiberoptic.

Paul McCormick, executive chairman of Cardiogenesis, said: “This is a significant milestone for the company. While there has been progress in the research of cell therapy in the treatment of advanced heart disease, the potential has yet to be fully realised in the clinical setting.

“The excitement about our combination therapy is based on the promising initial clinical results achieved by Reyes and others. These results build upon the in vivo research demonstrating that Phoenix increased stem cell survival in targeted heart muscle when compared to direct injection alone. Our focus is on proprietary delivery systems that will help realise the therapeutic promise of biologics and stem cells in the treatment of ischemic heart disease.”