Paclitaxel-Coated Coronary Stent in U.S. Trials

A U.S. clinical trial has begun on a coronary stent coated with the anti-cancer drug Paclitaxel to help prevent a stented artery from reclosing.

In as many as 40% of cases, a new blockage requiring further treatment develops at the site of angioplasty due to scar tissue growth and inflammation. The metal body of the new stent, called the Logix PTX, is coated with a minute quantity of Paclitaxel, which is gradually released into the cells of the arterial wall after stent placement. The drug acts to prevent excessive cell regrowth at the site of the angioplasty, which researchers anticipate will reduce or eliminate restenosis.

The Logix PTX was developed by Cook Incorporated (Bloomington, IN, USA). Clinical data from 180 patient studies conducted in Asian and European trials will be released later this year. Cook has licensed Paclitaxel from Angiotech Pharmaceuticals.

"We still have a long way to go before achieving our ultimate goal of receiving FDA clearance to market the Logix PTX stent in the United States,” noted John DeFord, president and CEO of Cook. "But we are confident that our strategic, methodical approach to evaluating drug-eluting coronary stents will result in a superior product that physicians worldwide can use.”




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