The Beta-Cath System (brachy-therapy) - First Intravascular Radiation Device Approved for the treatment of Coronary Restenosis.

The Beta-Cath system is the first intracoronary radiation device to be approved by the FDA. For use in patients suffering from "in-stent restenosis," a condition in which coronary stents become clogged with new tissue growth. For angioplasty patients, in-stent restenosis results due to a significant build up of scar tissue in and around the stent, which the patient's body mistakes for a foreign object. It is estimated that more than 100,000 patients in the U.S need treatment for this condition annually. Until now, there have been no effective treatments for in-stent restenosis other than bypass surgery, an expensive and highly invasive procedure.

Of the 800,000 people who undergo coronary angioplasty each year in the United States, about 75 percent of patients will receive coronary stents. Many of these patients, approximately 150,000 per year, will later suffer from recurrent blockage inside their stents, a condition known as "in-stent restenosis." Multiple randomized clinical trials have previously demonstrated the effectiveness of intracoronary radiation in the "secondary prevention" of restenosis, i.e. reducing the incidence of a second restenosis in patients who have already restenosed the first time after stent placement.

Baptist Health is the first hospital in Arkansas to offer this new technology. "Clinical trials show that vascular brachytherapy is highly effective and easy to use," said Dr. Randal Hundley, medical director of the Baptist Health Cardiac Cath Lab. The beta-cath system is the the device used in vascular brachytherapy to deliver beta radiation directly to the angioplasty site. The radation does not travel to other parts of the body. Vascular brachytherapy appears to inhibit cell growth and is intended to prevent restenosis of the artery at the treatment site. Studies have shown no significant adverse events associated with the use of vascular brachytherapy.

Results from the START (STents And Radiation Therapy) Trial, a randomized placebo-controlled study of 476 patients, demonstrated that use of the Beta-Cath Sytem significantly reduces the risk of restenosis and additional procedures to re-open stented coronary arteries. Specifically, the incidence of restenosis was 36% to 66% lower in patients treated with beta radiation than with placebo.

•   Catheterization Laboratory Efficiency - The recommended treatment dose is delivered in less than 5 minutes thereby minimizing valuable procedure time.
•   No Permanent Implant - A temporary dose of beta radiation is delivered locally to the treatment site.
•   Cost-Effectiveness - The Transfer Device containing the Radiation Source Train (RST) is reusable and requires minimal capital expenditure.
•   No Sophisticated Dose Calculation Planning - The Strontium90 / Yttrium90 isotope has a long half-life eliminating the need for re-calibration between uses.
•   Patient and Clinician Safety - The Transfer Device, containing the RST, is specially designed to shield beta radiation and significantly reduce unnecessary radiation exposure. - The use of a beta isotope allows the physician to remain with the patient throughout the procedure.
•   Promising Clinical Success - Promising clinical results cite a reduction in the need for repeat coronary interventions. These results suggest a significant improvement in patient outcomes which should lead to reducing overall healthcare costs.

Transfer Device (TD) containing a Radiation Source Train (RST)

Transfer Device: Reusable, handheld instrument designed for incorporation into the cath lab. Stores, shields, delivers RST to and from the targeted treatment site. Designed for ease of use and manual delivery allowing for operator control. Designed with a source- sensing system and interlocking mechanisms to optimize safety.

Radiation Source Train: Series of sealed cylindrical pure beta emitting isotopes (Strontium90/Yttrium90) exclusively designed to Novoste's specifications to optimize dose delivery. Contained in a dedicated enclosed lumen of the catheter, preventing RST - blood contact. Long half-life (28 years) allowing reusability and eliminating complicated dose calculation planning. Site specific exposure of beta radiation (penetration <1 cm in tissue) allowing clinicians to remain with the patient throughout treatment.

Source: Novoste Corp.