Abbott Laboratories Studying Safety, Efficacy Of Heart Stent Device Xience

Armen Hareyan's picture

Heart Stent Device Xience


Abbott Laboratoriesthis week enrolled the first patient in a clinical trial studying thesafety and efficacy of its experimental drug-eluting stent Xience inwomen, the Chicago Tribune reports. Abbott applied for FDAapproval for the device in June. If approved, Xience could reach themarket in the first half of 2008. The company plans to enroll 2,000women from about 100 sites in Europe, Asia, Canada and Latin America inthe study.

According to Abbott, the trial will look at a rangeof potential reasons why women have a low participation rate in stenttrials, as well as "specific aspects of women's health in relation to"heart disease -- such as general awareness, referral patterns andhormonal menopausal status. CDCestimates that women accounted for 51% of total heart disease deaths in2002. Abbott reports that women receive only 33% of balloon angioplastyprocedures, stents and bypass surgeries.

The study could "boostAbbott's future marketing efforts," as drug and medical device makersare "stepping up the marketing of health care products to women," the Tribune reports. (Japsen, Chicago Tribune,7/26). The trial "has the potential to enhance access to therapy forwomen by increasing physicians' and women's awareness aboutcardiovascular disease," Marie-Claude Morice -- a consultant to Abbottand principal investigator of the trial from the Institut Hospitalier Jacques Cartier inMassy, France -- said. "With more women dying of cardiovascular diseasethan men, it is tragic that women comprise only 25% of participants inall heart-related research studies," Morice said (Abbott release, 7/19).

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