Cardiogenesis Corporation (Pink Sheets: CGCP), today
announced that it has submitted an IDE (Investigational Device
Exemption) to the Food and Drug Administration to initiate a safety and
feasibility trial for its PHOENIX System in patients with refractory
angina. The PHOENIX handpiece is the first device specifically designed
to allow physician-directed tissue stimulation and injections of
biologic or pharmacologic agents to pre-determined areas of myocardium.
Dr. Guillermo Reyes, Department of Cardiovascular Surgery, Hospital Universitario La Princesa, Madrid, Spain commented on his preliminary clinical experience with the device. "To date I have successfully treated eighteen patients utilizing the PHOENIX with bone marrow derived stem cells. These were patients with severe angina and not candidates for coronary bypass or percutaneous intervention. At follow up, all of the patients improved by at least two classes of angina, and one-half were angina free. Based on the published literature and my own experience, laser channeling has proven to be a valuable clinical option. This preliminary study suggests the addition of stem cells is synergistic and this combination therapy offers the potential to improve clinical results and expand the utility of this approach."