Interim clinical results from 'OPEN I' study of the Stentys bifurcated stent reported at 'EuroPCR 2008' international cardiovascular meeting : No device-related events at 30-day follow-up on first-13 patients

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Medical device pioneer Stentys announced today that clinical results from the ‘OPEN I’ clinical study using its bifurcated stent were presented at last week’s ‘EuroPCR 2008’ international medical meeting on cardiovascular intervention.

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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

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.

About Stentys

Based in Paris, Stentys intends to make treatment of blocked coronary artery bifurcations as simple and effective as a conventional stenting procedure. The Company has developed the world's first next-generation dedicated stent for treatment of blocked coronary artery bifurcations that is designed so that hundreds of thousands of patients might avoid open-chest surgery. To date, the Stentys bifurcated stent has been successfully implanted in patients as part of the OPEN 1 trial, taking routine interventional time to complete; the patients were released from the ICU within hours of implantation of the Stentys bifurcated stent and were discharged from the hospital shortly after the procedure.

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Ronald C. Trahan
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