Cardiogenesis (Irvine, California), a company that makes laser transmyocardial revascularization (TMR), said it has submitted a pre-IDE to the FDA to initiate a feasibility trial for its Phoenix system in patients with refractory angina. The Phoenix combination delivery system combines intramyocardial laser channeling with the delivery of a biologic substance, the company said.
"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 ... 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 U.S."
The company 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 well documented in clinical applications for its angiogenic effect and accelerated wound healing response, according to Cardiogenesis.
McCormick told Medical Device Daily that the company has requested a meeting with the FDA in the next 60 days to determine if there are any issues with the study's protocol. Because TMR is already FDA-approved and "well described," he said, and the biologic the company is going to start with, PRP, is also "well described", the company hopes to begin a first in man study by the end of the year.
According to Cardiogenesis, the FDA approved the TMR procedure in 1999.
McCormick said that previously a number of companies pursued a percutaneous approach to reducing angina and found it was problematic. Since then, however, he said inter-operative channeling by surgeons has demonstrated reduced angina in early animal work.
"This is significant ... Cardiogenesis has been around for a long time, the challenge had been in the past that once the percutaneous approach for laser channeling demonstrated cells to be no better than placebo, the company has been reconfiguring itself, moving away from the selling of capital equipment to focusing on further developing the therapy in an inter-operative setting so to take it to the next level and finally begin these trials ... is a huge milestone for the company," McCormick said. "We believe it's a very promising approach."
The Center for Biologics Evaluation and Research is the lead reviewing center for the Phoenix application, Cardiogenesis noted.
Cardiogenesis is a medical device company specializing in the therapies for the treatment of chronic cardiac ischemia. The company's Holmium:YAG laser system and disposable fiber-optic accessories are used to perform TMR to treat patients suffering from angina. Surgical products and accessories for the Cardiogenesis TMR procedure, which are marketed in the U.S. and around the world, have been shown to reduce angina and improve the quality of life in patients with coronary artery disease, according to the company.
Last year the company presented a study at the annual meeting of the Western Thoracic Surgical Association which involved a group of consecutive patients treated with the Cardiogenesis holmium: YAG Laser TMR System. The authors concluded, "These preliminary results suggest that combining intramyocardial injection of PRP with TMR may be more efficacious at relieving angina and improving myocardial function than TMR alone," (Medical Device Daily, June 20, 2008).
The Phoenix system received a CE mark in 2006 and, according to the company, there have been more than 50 clinical cases completed outside the U.S.
"We've done some work over seas with our Phoenix device which is a hand piece that has a fiber for making the laser channels and then three needles that allows you to inject into that border zone, the early Euorpe work was positive, although preliminary," McCormick said. "The goal of initiating the clinical trial will be to test our Phoenix in an IDE study.