Cardiac and vascular device maker
received its first regulatory approval for its Achieve drug-coated coronary stent, but added that the product won't be available until a legal dispute is resolved.
After a review by the Medicines Control Agency and British Standards Institute, European CE Mark approval was granted, the company said. The heart disease-fighting Achieve stent system is a tiny wire mesh tube coated with drugs to keep reopened arteries from clogging. The stent incorporates Guidant's Multi-link Penta stent system components.
The commercial launch of the Achieve system is being delayed, however, by a dispute between Guidant and rival device maker
. Boston Scientific has challenged Guidant's right to sell the stent through a distribution agreement with Cook, which along with Guidant manufacturers the device under a drug license from Angiotech.
In June a judge rejected the distribution agreement. Subsequently, Guidant announced plans to acquire Cook for stock worth as much as $3 billion. The company expects to close on the deal in early 2003.
Shares of Guidant were last unchanged at $36.80 Friday on the
New York Stock Exchange