Cardiogenesis Corporation has submitted a pre-IDE (Investigational Device Exemption) to the Food and Drug Administration to initiate a feasibility trial for its PHOENIX System in patients with refractory angina. The system combines intramyocardial laser channeling with the delivery of a biologic substance. In 2006 PHOENIX received a CE MARK and there have been over 50 clinical cases completed till date outside of the US.
The early clinical results achieved with TMR plus biologics suggest the potential of this combination therapy; to not only mitigate the debilitating effects of refractory angina, but potentially to improve cardiac function as well, said Paul McCormick, Executive Chairman. Animal work by Dr. Patel demonstrated that the pre-treatment of myocardium with TMR enhanced cell viability and uptake when delivered with the Cardiogenesis PHOENIX combination delivery system, compared to cell therapy alone. This submission is an important step towards initiating the feasibility trial in the United States.
Cardiogenesis plans to evaluate the therapeutic effect of delivering Platelet Rich Plasma (PRP) in combination with TMR. PRP is derived from the patient’s own circulating blood and is documented well in clinical applications for its accelerated wound healing response and angiogenic effect.
During the next 60 days Cardiogenesis expects to meet with CBER to identify any additional information required to begin the feasibility trial.