FDA approves Guidant's ACS RX LIFESTREAM catheter line extensions; FDA also approves perfusion balloon catheter trial results.

INDIANAPOLIS--(HealthWire)--June 29, 1995--Guidant Corporation (NYSE and PSE: GDT) today announced that its Advanced Cardiovascular Systems, Inc. (ACS) business unit has received U.S. Food and Drug Administration (FDA) approval in the U.S. to manufacture and sell line extensions for the ACS RX LIFESTREAM(TM) coronary dilatation catheter for the treatment of blocked arteries in the heart. Beginning this week, a 10mm length will be available in a limited release; a 30mm length and quarter sizes for the 20mm balloon will be available in early fall. In March, ACS launched its 20mm length ACS RX LIFESTREAM catheter. Currently, Guidant is the only company with a perfusion catheter approved for commercialization in the United States.

The ACS RX LIFESTREAM perfusion catheter is the first high-performance, low-profile, rapid exchange catheter with high pressure capability. The P-Flex(TM) balloon material refolds better than other non-compliant balloons. The crossing profile is dramatically reduced compared to previous perfusion catheters. With the latest line extensions, ACS continues to offer physicians the breadth of products to meet their clinical needs.

``We are very pleased to have received approval to offer our customers the extended family of ACS RX LIFESTREAM products in such a short time frame,'' said Ginger Howard, president of ACS and a Guidant vice president. ``The ACS RX LIFESTREAM catheter provides many important features in one system, allowing physicians increased flexibility in their treatment strategy without performance trade- offs. With these line extensions, we can now offer our customers a family of ACS RX LIFESTREAM perfusion catheters that better meets their broad clinical needs.''

The quick approval time for the ACS RX LIFESTREAM catheter line extensions, which amounted to less than 100 days, resulted from an electronic filing. In 1994, Guidant business units took part in the FDA pilot program to evaluate the electronic submission and processing of premarket approval supplements (PMAS) and premarket notifications (510K). ``Last fall, Guidant was the first medical device company to file electronically with the FDA,'' stated Ronald Dollens, Guidant president and chief executive officer. ``Electronic filings will significantly reduce review time, and will be a major benefit to the entire industry.''

Currently, perfusion catheters are expanding into first-line therapy since the technology offers many benefits to patients and to physicians that are important during percutaneous transluminal coronary angioplasty (PTCA). One of the main benefits of perfusion is the maintenance of continuous blood flow to the heart during the procedure.

These outcomes were recently acknowledged when ACS received FDA approval to market the results of the perfusion balloon catheter (PBC) trial, which showed that ACS perfusion catheters can significantly improve PTCA patients' clinical success rates when using prolonged inflations. A randomized, multi-center study involving 478 patients, the PBC trial compared prolonged and standard inflation strategies. At the end of Phase 1, the major dissection rates were 3% with prolonged inflations, compared to 9% with standard inflations (P=0.003), and the procedural success rate was 95% with prolonged inflations compared to 89% with standard inflations (P=0.016).

In patients initially assigned to prolonged inflations, the use of prolonged inflations in Phase 2 of the study improved the procedural success rate from 95% in Phase 1 to 98% at the end of Phase 2. Similarly, in patients initially assigned to standard inflations, the use of prolonged inflations improved the procedural success rate from 89% in Phase 1 to 98% at the end of Phase 2. The study concluded that the use of prolonged balloon inflations with a perfusion balloon as an initial inflation strategy, or to improve a suboptimal result, is an effective strategy in elective PTCA.

The PBC trial was coordinated by E. Magnus Ohman, M.D., assistant professor of medicine and coordinator of clinical trials for interventional cardiology, at Duke University Medical Center in Durham, North Carolina.

A leader in the medical device industry, Guidant Corporation provides innovative, cost-effective products and services to the global cardiology and minimally invasive surgery marketplaces. Guidant comprises Advanced Cardiovascular Systems, Inc. (ACS), Cardiac Pacemakers Inc. (CPI), Devices for Vascular Intervention, Inc. (DVI), Heart Rhythm Technologies, Incorporated (HRT), Origin Medsystems, and the company's international affiliates.

CONTACT: Advanced Cardiovascular Systems, Inc., Santa Clara

Ronda Prothro, 408/235-3420

or

Guidant Corporation, Indianapolis

Emile Godfrey Jr., 317/971-2030