Jul 12, 1999
Guidant Announces FDA Approval of ACS OTW PHOTON Coronary Dilatation Catheter

Indianapolis, IN - Guidant Corporation (NYSE and PCX: GDT) a world leader in the treatment of coronary artery disease, today announced that it has received U.S. Food and Drug Administration approval to market the ACS OTW PHOTON(tm) Coronary Dilatation Catheter.

Coronary dilatation catheters are used to open blocked coronary arteries during percutaneous transluminal coronary angioplasty (PTCA). In 1999, more than 1.5 million people worldwide will require an interventional procedure, such as PTCA.

The ACS OTW PHOTON Coronary Dilatation Catheter features several unique technologies, including LoFold(tm) balloon technology for reduced crossing profiles, short tapers and dual markers for precise lesion treatment, and XCELON(tm) 6 Balloon Material for balloon flexibility and excellent compliance. It also includes HYDROCOAT(tm) Hydrophilic Coating and UNITRACK(tm), a new transitionless shaft. These features significantly improve the catheter''s ability to access lesions and track through tortuous anatomy. This advanced technology will better enable physicians to treat lesions during percutaneous transluminal coronary angioplasty (PTCA). PTCA is a significant alternative to coronary bypass surgery in specific patient types.

In addition to the approval of the ACS OTW PHOTON, which is a primary-use coronary dilatation catheter, the ACS OTW SOLARIS(tm) Coronary Dilatation Catheter was also recently approved by the FDA. The ACS OTW SOLARIS is a high-pressure, over-the-wire catheter that will enable physicians to treat multiple blockages (lesions) with high pressures during PTCA, pre-stent placement, or for post-stent dilatation of the ACS MULTI-LINK DUET(tm) Coronary Stent.

The ACS OTW PHOTON is available in lengths of 10, 15, 20, 25, and 30 mm, with diameters ranging from 1.5 - 4.0 mm. The ACS OTW SOLARIS is available in lengths of 9, 15, 20, 25, and 30 mm with diameters ranging from 2.5 - 4.0 mm. The combination of indications and sizes approved for the OTW PHOTON and OTW SOLARIS coronary dilatation catheters offer a comprehensive solution for over-the-wire procedures.

"The ACS OTW PHOTON and ACS OTW SOLARIS Coronary Dilatation Catheters further expand Guidant''s line of high-performance over-the-wire coronary dilatation products," said Ginger L. Graham, President of Guidant''s Vascular Intervention Group. "Combined with the highly successful ACS MULTI-LINK DUET(tm) Coronary Stent System, the ACS HI-TORQUE BALANCE MIDDLEWEIGHT(tm) and the ACS VIKING(tm) Guiding Catheter, physicians now have access to a complete over-the-wire system solution to treat coronary artery disease."

A global leader in the medical device 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.