Medtronic Inc Announces Results From Prospective, Single-arm Clinical Trial Evaluating Medtronic CoreValve System In Patients With SAVR

Medtronic Inc announced results from its prospective, single-arm clinical trial evaluating the Medtronic CoreValve System in patients with severe aortic stenosis who are at high-risk for surgical aortic valve replacement (SAVR). These data, presented at The American College of Cardiology’s (ACC's) 61st Annual Scientific Session & Expo in Chicago, showed that patients in a real-world setting experienced high procedural success combined with positive clinical outcomes. The CoreValve System is currently limited to investigational use in the United States. Called the Medtronic CoreValve ADVANCE Study, survival rates were high at both 30 days (95.5%) and 6 months (87.2%), rates that are consistent with previously reported data from national registries in Europe. The procedural success rate was 97.8%, and overall complication rates were low with stroke rates of 2.9% and MACCE (Major Adverse Cardiac & Cerebrovascular Events) rates of 8.3% at 30 days. Patients in the study experienced significant improvement in valve function (mean gradient decreased from 45.6 mmHg at baseline to 9.3 mmHg at 30 days). The study is one of the largest multicenter transcatheter valve trials to date, with 1,015 patients (mean age of 81 years) consecutively treated at 44 experienced transcatheter aortic valve implantation (TAVI) centers in 12 countries internationally. Clinical endpoints in the trial were calculated according to Valve Academic Research Consortium (VARC) standardized definitions.