Jun 28, 2000
Guidant Announces Completion of Milestone in Heart Failure Clinical Study
Indianapolis, IN and Santa Clara, CA - Guidant Corporation (NYSE and PCX: GDT) a world leader in the treatment of coronary artery disease, today announced FDA marketing clearance for two new coronary dilatation catheters. These catheters incorporate significant technological advancements for angioplasty procedures, while offering the smallest profiles of any coronary dilatation catheter currently available. The CrossSail(tm) Coronary Dilatation Catheter has a rapid-exchange design, which allows physicians to utilize the sole operator technique preferred due to its ease of use and faster procedure time. Its over-the-wire counterpart, the OpenSail(tm) Coronary Dilatation Catheter, allows physicians who prefer the over-the-wire design to use this more familiar technique. "Guidant's CrossSail and OpenSail Coronary Dilatation Catheters utilize some of the most advanced technologies available for angioplasty systems," said John M. Capek, Ph.D., president of Guidant's Vascular Intervention Group. "With the launch of these new balloon dilatation catheters, we are significantly advancing our offering of leading-edge tools to interventional cardiologists to facilitate treatment for a greater number of patients suffering from coronary artery disease." Launched earlier this year in CE Mark countries, physicians have praised the CrossSail's numerous advances, including its ability to cross difficult, tight lesions and for its excellent rewrap and re-cross, which allow physicians to use the same balloon dilatation catheter to treat multiple lesions. Its wide range of sizes was also cited as being highly beneficial for use with a variety of patient anatomies. Guidant's European balloon dilatation catheter sales have increased 25 percent since the launch of the CrossSail in Europe. The CrossSail will be launched throughout the U.S. in early July. The launch of the OpenSail will begin upon completion of the CrossSail launch. "We have been very successful with the CrossSail due to its low profile and re-cross ability," said Professor Ivan De Scheerder from the University Hospital in Leuven, Belgium. "CrossSail has proven to be a great frontline performer." The unique technologies incorporated into both the CrossSail and the OpenSail Coronary Dilatation Catheters provide the physician with new levels of performance and ease of use for both traditional angioplasty procedures and pre-dilatation for stenting. Among the technical advances and features are: Both the CrossSail and the OpenSail are indicated for use in native coronary vessels and saphenous vein grafts, which are harvested from the leg and used to bypass blocked arteries during coronary bypass surgery. They are both available in 38 sizes, including two that Guidant is introducing for the treatment of larger diameter vessels (4.5 and 5.0 mm). Guidant offers the broadest RX size range currently available by any manufacturer of coronary dilatation catheters. In addition, this is the broadest size range ever offered by Guidant for both RX and OTW catheters. Coronary dilatation catheters are used to open blocked coronary vessels during percutaneous transluminal coronary angioplasty (PTCA), which is a significant alternative to coronary bypass surgery in specific patient types. In 1999, more than 1.5 million people worldwide required an interventional procedure, such as PTCA. Approximately one-quarter of those patients were treated with a Guidant dilatation catheter. The CrossSail is the successor to Guidant''s highly successful ACS RX GEMINI(tm) Coronary Dilatation Catheter, which was introduced in 1999. A global leader in the medical technology industry, Guidant provides innovative, minimally invasive and cost-effective products and services for the treatment of cardiovascular and vascular disease. For more information about Guidant''s products and services, visit the company''s Web site at http://www.guidant.com.