Coronary Radiation System Receives FDA Approval
First Tested at Methodist DeBakey Heart Center

The FDA has approved a radiation therapy system for preventing the repeated narrowing of coronary arteries already stented, a system first used by physicians at the Methodist DeBakey Heart Center.

After proving successful in national clinical trials, the Guidant GALILEO Intravascular Radiotherapy System was approved to treat in-stent restenosis, the recurrence of a blockage in a coronary artery that had been previously propped open with a coronary stent. This condition affects as many as 30 percent of patients treated with coronary stents each year. Although a narrowed stent can be reopened with another balloon procedure, the likelihood of repetitive renarrowing can be as high as 50 percent.

At the Methodist DeBakey Heart Center, 108 patients participated in four randomized clinical trials. Of those treated with the radiation system, only 16 percent experienced renarrowing of the arteries within the stent, compared to 48 percent of those patients who did not receive radiation treatment.

"This is significant because if stents remain open for more than a year, the patient has an excellent chance of never needing another treatment in that area," said Dr. Al Raizner, director of the Methodist DeBakey Heart Center and co-developer of part of the Guidant system. "We are improving the treatment of coronary artery disease through a catheter system."

By preventing the renarrowing of arteries, patients can avoid open-heart surgery, the only option after repeated unsuccessful angioplasties, said Dr. Raizner, who served as principal investigator for the first two GALILEO clinical trials.

"With FDA approval, more patients nationwide will be able to benefit from the revolutionary treatment," he said.

The GALILEO system is comprised of three components: a centering catheter, a source wire and a source delivery unit. The centering catheter is designed to ensure that radiation is applied evenly within the artery during treatment.

The device automatically advances, retracts, stores and shields the radioactive source wire that provides the treatment. Further, the source delivery unit automatically calculates the correct dose of radiation needed, eliminating the need for physicians to perform time-consuming calculations and reducing the possibility of human error.

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