Intracoronary Radiation Device Cleared by FDA

Food and Drug Administration (FDA), the first of its kind to be cleared by the FDA. The system is indicated for use in patients suffering from in-stent restenosis.

Results of a randomized trial involving 476 patients demonstrated that use of the Beta-Cath System significantly reduces the risk of stenosis and the need to re-open stented coronary arteries. The incidence of restenosis was 36-66% lower in patients treated with beta radiation than in those treated with placebo. Similarly, patients in the trial treated with radiation had a 34% lower frequency of repeat revascularization procedures than patients who did not receive the treatment. The data also showed that patients treated with the Beta-Cath System had a 31% lower rate of major adverse cardiac events than those in the placebo group.

To treat patients with the new procedure, cardiologists re-open the blocked coronary artery with a catheter-based intervention such as balloon angioplasty. The Beta-Cath is then positioned inside the artery, at the same location of the previous intervention. Next, the strontium-90 (beta radiation) seeds are hydraulically delivered to the site at the end of the closed-end catheter, where they remain for three to five minutes before being withdrawn. The entire treatment time is only about 10 minutes. The Beta-Cath System is the product of Novoste Corp. (Atlanta, GA, USA).

"This small, portable beta radiation system has provided a safe, effective and practical method for solving this most difficult problem,” said Spencer B. King III, M.D., co-director of Atlanta Cardiovascular Research Institute.