Medtronic reports positive data from CoreValve US pivotal trial

3 April 2016 (Last Updated April 3rd, 2016 18:30)

Global medical technology company Medtronic has revealed new data from the High Risk Study of the CoreValve US Pivotal Trial which is said to have demonstrated superior clinical outcomes for transcatheter aortic valve replacement (TAVR) with the CoreValve System as compared to surgical aortic valve replacement (SAVR) out to three years.

Global medical technology company Medtronic has revealed new data from the High Risk Study of the CoreValve US Pivotal Trial.

The trial is said to have demonstrated superior clinical outcomes for transcatheter aortic valve replacement (TAVR) with the CoreValve System as compared to surgical aortic valve replacement (SAVR) out to three years.

In the trial, which included 407 patients, 228 were treated with TAVR while 179 patients were administered with SAVR treatment.

"Most importantly, the new data supports the viability of TAVR out to three years with no signal of a significant increase in mean gradient or aortic regurgitation."

Patients treated with TAVR have exhibited better result compared to surgery for the combined endpoint of all-cause mortality or stroke and for all stroke.

TAVR has registered a lower all-cause mortality compared to SAVR-treated patients.

University of Michigan Frankel Cardiovascular Centre Herbert Sloan Collegiate Professor of Cardiac Surgery Michael Deeb said: "It's reassuring to see that the CoreValve High Risk Study continues to show that TAVR is superior to surgery at three years for the combined endpoint of mortality and stroke, which has the most important impact on patients.

"Most importantly, the new data supports the viability of TAVR out to three years with no signal of a significant increase in mean gradient or aortic regurgitation."

The supra-annular design of the CoreValve System has facilitated an improved valve performance in the TAVR group with sustained single-digit gradients (measurement of blood flow through the valve) which was lower than surgery patients during the course of the trial.

The CoreValve System also ensured safety to surgery in these patients with lowered rates of major adverse cardiovascular and cerebrovascular events (MACCE) in the CoreValve group.

In 2014, the CoreValve System has been approved by the US Food and Drug Administration for patients at extreme risk and high-risk for surgery and happens to be the first TAVR device approved in the US for valve-in-valve procedures in both high and extreme risk patients with failed surgical valves.

After being the first TAVR device to receive CE Mark in 2007, the CoreValve System is utilised by more than 100,000 patients across over 60 countries.