Bard begins XT coronary stent clinical trial.

MURRAY HILL, N.J.--(BUSINESS WIRE)--March 18, 1997--C. R. Bard, Inc. (NYSE-BCR) has received FDA approval to implant its XT(TM) coronary stent in up to 50 patients at multiple sites in the U.S.

The Bard study will be conducted under the direction of principal investigator Joseph Carrozza, M.D. of Boston's Beth Israel Deaconess Medical Center and Harvard Medical School. Dr. Carrozza performed the first implantation of the Bard XT stent in the U.S. on March 4, 1997, with what he characterized as an "excellent" result.

The approval for the implantation of 50 patients was granted while the FDA completes its review of Bard's investigational device exemption (IDE) application. IDE approval is anticipated to expand the study to 1,100 patients and 40 hospitals.

"The scope of this study is tangible proof of Bard's ongoing commitment to the interventional cardiology market," said chairman and chief executive officer, William H. Longfield. "Through careful medical science, we aim to be a key player in the fast growing coronary stent market producing an advanced product that combines technological superiority and clinical performance at a competitive price."

The Bard XT stent is currently sold in France, Germany, Italy, the United Kingdom, Australia and South America. Clinical trials are currently underway in Japan and Canada. "Our stent has achieved widespread acceptance overseas," said Longfield. "It is truly an innovative product which offers interventional cardiologists a unique stent for use in their clinical practices."

Even though coronary stents have only been available in the U.S. for under four years, they have quickly emerged as one of the fastest growing segments of the medical device industry. Estimates are that the annual U.S. stent market is as high as $600 million. Currently, however, there are only two coronary stents approved by the FDA for use in the U.S.

"We are mobilizing Bard's resources to seize this market opportunity," explained Longfield. "We plan to emerge as a leader in the U.S. interventional cardiology market, and the launch of this nationwide clinical study is one milestone toward achieving that goal."

According to Dr. Carrozza, what sets the Bard XT stent apart from other coronary stents currently available is the combination of flexibility and strength derived from its unique modular design. "We hope the Bard XT stent's flexibility will make it easier to deliver and place, especially in difficult cases," he said.

The Bard XT stent's radiopacity also makes it easier to visualize on fluoroscopy," said Dr. Carrozza. "We hope this increased visualization will result in more accurate placement." He also noted that the Bard XT stent is the first coronary stent currently under investigation in the U.S. that is not premounted on a balloon catheter. Thus, it may be possible to complete the entire stent procedure with a single balloon catheter, using the same balloon for predilatation as well as stent delivery, which has the potential to yield cost savings--an attractive feature in today's cost-conscious environment. During the clinical trial, the Bard XT stent will be delivered on the ProCross(TM) Rely(TM) over-the-wire balloon catheter which features Bard's unique Rely balloon material.

The Bard XT stent is a balloon-expandable stent composed of multiple modules, each one consisting of a zigzag ring and connector welded to a longitudinal flexible spine. The rings and spine are made of 316 LVM stainless steel. In the U.S. the Bard XT stent will be available in lengths ranging from 6 to 19mm.

Coronary stents are increasingly used in conjunction with balloon angioplasty to prevent later renarrowing of the artery (restenosis), which occurs in one-third to one-half of angioplasty procedures performed. To minimize the chances of restenosis, a stent is implanted in a patient's artery just after balloon angioplasty and positioned at the site of the obstruction. When the balloon is inflated, the stent expands and is pressed against the inner walls of the artery. After the balloon is deflated and removed, the stent remains in place, a metallic scaffold that keeps the artery open. About 860,000 angioplasties are performed worldwide each year.

C. R. Bard, Inc., headquartered in Murray Hill, NJ, is a leading multinational developer, manufacturer and marketer of health care products.

CONTACT: C.R. Bard, Inc., Murray Hill

E.L. Parker, [phone]