Medtronic Touts Endeavor Safety Results; Are Late Lumen Loss Issues Over?
This article was originally published in The Gray Sheet
Executive Summary
Medtronic is stressing the deliverability of its Endeavor drug-eluting stent and safety results from the ENDEAVOR-II trial to distinguish the device from competitors, but concerns with late lumen loss remain
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EuroPCR In Brief
Edwards Lifesciences: Data from the PARTNER EU trial of Edwards Sapien transcatheter valve implanted with a transapical approach through an incision in the rib cage show 30-day and six-month survival rates of 81% and 58%, respectively, in 130 patients, firm reports May 20 at the EuroPCR meeting in Barcelona. Survival at one year was 50%. Survival rates in patients receiving the device through the femoral artery were 93% at 30 days and 90% at six months. The one-year survival rate was 78%. The results show that "as we move into lower-risk patients, survival continues to improve, particularly in the transapical group," says Larry Wood, Edwards' corporate vice president for transcatheter valve replacement. The study was the first to combine both access approaches at the same clinical trial sites, according to Edwards. Despite the learning curve for investigators, overall 30-day mortality and the mortality rate in each delivery cohort were better than expected, the firm says. Edwards also presented results from the SOURCE registry, which includes 1,038 European patients treated with Sapien. Data show a 30-day survival rate of 93.7% in transfemoral procedures and 89.7% in transapical procedures. Edwards is aiming to complete enrollment of a 1,040-patient FDA study this year. The firm hopes to launch Sapien in the U.S. by the end of 2011. Other companies developing transcather valves include Medtronic and St. Jude
EuroPCR In Brief
Edwards Lifesciences: Data from the PARTNER EU trial of Edwards Sapien transcatheter valve implanted with a transapical approach through an incision in the rib cage show 30-day and six-month survival rates of 81% and 58%, respectively, in 130 patients, firm reports May 20 at the EuroPCR meeting in Barcelona. Survival at one year was 50%. Survival rates in patients receiving the device through the femoral artery were 93% at 30 days and 90% at six months. The one-year survival rate was 78%. The results show that "as we move into lower-risk patients, survival continues to improve, particularly in the transapical group," says Larry Wood, Edwards' corporate vice president for transcatheter valve replacement. The study was the first to combine both access approaches at the same clinical trial sites, according to Edwards. Despite the learning curve for investigators, overall 30-day mortality and the mortality rate in each delivery cohort were better than expected, the firm says. Edwards also presented results from the SOURCE registry, which includes 1,038 European patients treated with Sapien. Data show a 30-day survival rate of 93.7% in transfemoral procedures and 89.7% in transapical procedures. Edwards is aiming to complete enrollment of a 1,040-patient FDA study this year. The firm hopes to launch Sapien in the U.S. by the end of 2011. Other companies developing transcather valves include Medtronic and St. Jude
Panel Advises 5,000-Patient Postmarket Study For Medtronic’s DES
Medtronic should conduct a large postmarket study to monitor late stent thrombosis and help define the appropriate antiplatelet drug regimen for drug-eluting stent patients, FDA's Circulatory System Devices Panel recommended at its Oct. 10 meeting in Gaithersburg, Md