Cardiogenesis out of Irvine, CA is reporting that it 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 Revascularization Delivery System is a combination device designed to perform two primary functions:
1. Being equipped with holmium:YAG laser, the system can perform Transmyocardial Revascularization (TMR) during open heart surgeries, a common procedure usually used for end-stage coronary artery disease. During TMR the surgeon makes transmyocardial holes with a laser, and that is thought to be responsible for induction of angiogenesis in myocardium.
2. PHOENIX handpiece is specifically designed to let cardiac surgeons inject “biologic or pharmacologic agents to pre-determined areas of myocardium” during TMR. The hope is that in the future this technology will allow us to provoke a more robust angiogenesis, or maybe, depending on the agent, allow the delivery of positive inotropes to compromised areas of myocardium.
In its press release, Cardiogenesis states that some clinicians in Europe are already experimentally using the PHOENIX System in concert with bone marrow derived stem cells, and that “the addition of stem cells is synergistic and this combination therapy offers the potential to improve clinical results.”
More about the device:
The PHOENIX includes an integral CrystalFlex fiberoptic component consisting of thirty-seven 100 µm diameter fibers, identical to the fiberoptic component currently in use in the FDA approved Sologrip® III and PEARL(TM) 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.
The PHOENIX System utilizes the Ho:YAG thermoacoustic stimulated tissue zone and introduces additional potent, therapeutic agents into the targeted myocardium to dramatically enhance the healing process.
Improved long-term survival Reduced cardiac-related hospitalizations Enduring long-term angina relief (beyond 5 years) Reduction in anti-anginal and cardiac medications Improved quality of life Robotic and thoracoscopic treatment options (PEARLTM) Advances the application of therapeutic biologics in treating heart disease Convenient combination delivery tool designed for one-handed operation Precisely and accurately delivers measured biologic to the thermoacoustic stimulated tissue zone