PALO ALTO, Calif., — Varian Medical Systems, Inc. (NYSE: VAR) today announced an agreement with Cordis Corporation, a Johnson & Johnson company (NYSE: JNJ), to develop, supply and service radiotherapy components and equipment for a promising new Gamma brachytherapy treatment to help prevent coronary artery reblockage (restenosis).
Varian will provide gamma radiation sources and develop automated equipment for Cordis' catheter-based system that temporarily places a small radiation source within a freshly cleared artery to inhibit restenosis – regrowth of tissue and plaque. Cordis, the leader in this emerging market for interventional cardiology, recently reported successful clinical trials of this procedure, which is under review by the U.S. Food and Drug Administration (FDA). Cordis was first to apply to the FDA for clearance to market the gamma-based system.
Coronary balloon angioplasty is used to reopen blocked arteries in some 900,000 patients annually worldwide with about 80 percent of the patients receiving a stent – a tiny scaffold usually cut from surgical stainless steel, that is inserted into the artery and expanded to the full diameter of the vessel to hold it open. Studies show restenosis can occur in as many as 40 percent of the patients who receive this treatment.
Radiation, which retards cell growth, shows promise in effectively preventing the regrowth of tissue. Results of three major clinical trials funded by Cordis Corporation, including the most recently announced in September 1999, noted a 41 percent reduction of in-lesion restenosis and a 57 percent reduction of in-stent restenosis after nine months.
Vascular brachytherapy uses a closed-end catheter that contains radioactive seeds of IR-192 that can deliver a therapeutic dose up to a diameter of several millimeters. A team of physicians including cardiologists and radiotherapists places the catheter within the artery after completing a balloon angioplasty. Once the catheter has been properly positioned, a wire containing the seeds is inserted into the catheter and delivered adjacent to the lesion site for treatment, where it remains for a matter of minutes.
Cordis Corporation, a world leader in coronary and peripheral stents, diagnostic and balloon catheters and related cardiovascular devices, and Varian Medical Systems, will work closely together in providing a system to hospitals for delivering this new procedure as soon as it receives FDA clearance. Varian Medical Systems, the world leader in radiotherapy, is developing brachytherapy solutions where radiation is delivered internally through catheters.
In Europe, delivery equipment, catheters and radioactive wires will be supplied to hospitals and clinics through Cordis' international sales and distribution network. Varian will co-market the equipment, replenish radiation sources within the equipment, assist in training medical professionals, and support the equipment through its worldwide service organization.
"Two companies, each a leader in their field, are coming together to provide an effective treatment for a real problem affecting hundreds of thousands of patients with coronary artery disease around the world," said Robert Sutherland, Ph.D., president of Varian Biosynergy, the Varian Medical Systems subsidiary that will direct this business.
"Cordis has pioneered this approach and has the necessary strong relationships with the cardiology community to rapidly make this procedure available for patients."
"Expertise in radiotherapy is essential to optimize this exciting new treatment for patients with coronary artery disease and Varian Medical Systems, the world leader in radiotherapy, will be a strong partner in this effort," said Patrick J. O'Neill, Ph.D., Cordis Group Vice President, Research & Development and Business Development Worldwide. "Together, the companies will provide physicians with a simple, safe, and cost-effective system for carrying out this life-saving procedure."