Medtronic touts CoreValve TAVR real-world registry data

Medtronic (NYSE:MDT) said today it released the 1st real-world registry study of its CoreValve transcatheter aortic valve replacement, reporting outcomes in-line with its clinical trials of the device.

The 6,160-patient Society of Thoracic Surgeons and American College of Cardiology TVT registry study reported a 5.2% rate of all-cause mortality and 2.6% rate of stroke at 30 days. Those rates are consistent with the 6.9% and 5% rates, respectively, from the pivotal trial, Fridley, Minn.-based Medtronic said.

“It is reassuring to see that the profound clinical results in the U.S. CoreValve Pivotal studies were replicated among patients at high or extreme surgical risk in a ‘real-world’ clinical setting. The favorable results from the CoreValve analyses are likely attributable to operator experience, thoughtful patient selection, and effective education and training based on the ‘best practices’ learned in the U.S. pivotal studies, including the use of CT-based sizing. We believe that these results indicate that the CoreValve self-expanding bioprosthesis is safe and effective in patients with severe aortic stenosis unsuitable for surgery across a wide spectrum of U.S. medical centers,” co-principal investigator Dr. Jeffrey Popma of Boston’s Beth Israel Deaconess Medical Center said in prepared remarks.

The registry study reported that implantation was sucessful in 98% of cases, with only 0.7% requiring conversion to surgery. The pivotal trial reported a 96.8% successful implantation rate and 0.2% rate of cases which required conversion to surgery.

Of patients in the registry, 89.3% were able to be treated via transfemoral access, compared to 77.3% in the pivotal trial, and only 1.5% required valve related readmissions, compared to 5.9% in the pivotal trial.

The CoreValve demonstrated a mean gradient of 7.7 ± 4.2 mm Hg at 30 days and 8.1 ± 3.9 at 1 year, Medtronic reported. Patients reported improved quality of life on the Kansas City Cardiomyopathy Questionnaire, improving from 40.9% to 68.7%, and a reduction in NYHA Class III/IV symptoms from 83.8% to 13.4%.

Patients in the registry trial were similar to those in the pivotal trial in terms of age, average STS risk model score and similar comorbidity profiles and NYHA classes, Medtronic said.

The CoreValve system is approved by the FDA for patients at extreme risk for surgery, and won CE Mark approval in the European Union in 2007.

The post Medtronic touts CoreValve TAVR real-world registry data appeared first on MassDevice.

from MassDevice http://ift.tt/1N9nRVT