Thursday, October 9, 2008

Boston Scientific done gathering patients for newest stent trials

By Mass High Tech Staff

Medical device maker Boston Scientific Corp. completed the patient enrollment for its two-part clinical trial program entitled PERSEUS. The Natick-based firm is investigating its newest paclitaxel-eluting stent called Taxus Element. The trial enrolled 1,500 patients with coronary artery lesions at 100 sites around the world. The study began in July 2007.

Boston Scientific will test the Taxus Element stent against the company’s own Taxus Express stent.

The program’s first part, dubbed the workhorse study, enrolled 1,264 patients in the United States, Australia, New Zealand and Singapore. The primary goal will measure target lesion failure (TLF) after one year and will also look at “in-segment percent diameter stenosis” after nine months, the company reported.

The second part of the program, called the small vessel study, will investigate “in-stent late loss” after nine months, and TLF after one year. It will include 224 patients enrolled in the U.S.

On Tuesday, an appeal from Boston Scientific to the U.S. Supreme Court relating to a patent infringement lawsuit filed by Johnson & Johnson Co. was rejected. The lawsuit centers around infringement of a Johnson & Johnson patent for coronary stents.

The rejection preserves a final judgment decision made a week ago in the U.S. District Court in Delaware in which the Natick medical devices maker was ordered to pay Johnson & Johnson a total of $703 million, between patent damages and pre-judgment interest.

And earlier today, Boston Scientific noted that a significant sell-off of stock held by its founders was actually triggered by an automatic trading program run by a trust established for founder John Abele’s children and sparked in part by the collapse of Lehman Brothers.

Boston Scientific (NYSE: BSX) reported a 2007 net loss of $495 million on revenue of $8.4 billion.