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"Failing to DELIVER"
"While the DELIVER study did not meet its primary end point, the results demonstrate the safety and a trend toward efficacy of the ACHIEVE Drug Eluting Coronary Stent System," Dr John M Capek, president, vascular intervention, for Guidant, commented. "In addition, the study further demonstrates the excellent clinical performance of the PENTA Coronary Stent System."
The foundering of the 1042-patient DELIVER trial is another blow to Guidant's hopes of gaining ground in the drug-eluting stent race. In March of 2002, Guidant announced it was halting its ACTION trial investigating actinomycin-D-coated stents, due to "unacceptably high" restenosis rates in the trial's first 90 patients. Guidant is also embroiled in ongoing legal wrangling with rival Boston Scientific following a court's decision to grant Boston Scientific's request for a permanent injunction of all activities concerning paclitaxel-coated stents under the agreements between Cook and Guidant. With the Cook-Guidant merger now expected to fall through, Guidant will have to pay Cook a $50-million breakup fee.
Guidant executives point out that Guidant is still moving ahead with its own drug-eluting stent program using everolimus (Novartis Pharma AG) and expects to implant its first everolimus-coated stent in a human subject sometime this spring as part of its Vision-E trial. Even if this new strategy proves successful, however, Guidant cannot expect to have a drug-eluting stent on the market before 2005.
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