May 20, 2008 - There were no device-related events at 30 days follow-up of the first 13 patients in the OPEN I clinical study using its bifurcated stent, according to the principal investigator who presented the report at the EuroPCR 2008 international medical meeting on cardiovascular intervention.
The data, presented by Eberhard Grube, M.D., chief of Cardiology and Angiology at HELIOS Heart Center (Germany) and principal investigator of the OPEN I study, included safety results after 30 days post-implantation of the Stentys bifurcated stent in the first 13 patients.
"We were very pleased to report that there were no device-related events at 30 days follow-up of the first 13 patients in our study," said Dr. Grube. "The Stentys bifurcation stent seems safe and represents a promising technique for optimal treatment of bifurcated lesions. The procedure is identical to known techniques and makes possible excellent reconstruction of the bifurcation."
The mean age of the 13 patients was 61 years. Seventy-eight percent of the lesions were classified as "class B" (ACC guidelines); 54 percent had lesions in the entire main vessel, both above and below the bifurcation site. Dr. Grube reported "100% procedural success", with no device-related event during hospitalization and up to 30 days at follow-up.
The annual 'EuroPCR' medical meeting contributes to the advancement of education and information about existing and new technologies in the fields of cardiovascular intervention.
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