US-based Medtronic has launched a new clinical trial designed to evaluate the safety and effectiveness of the new CoreValve Evolut R recapturable system.
Medtronic's CoreValve Evolut R Recapturable valve and delivery system has features designed to advance deliverability and valve performance, while providing the option to recapture; and reposition the CoreValve Evolut R valve during deployment, if needed, while performing transcatheter aortic valve implantation (TAVI).
Surgeries have already taken place in Australia at the Monash Medical Centre Southern Health, Melbourne.
The company plans to enrol up to 60 patients who have severe symptomatic aortic stenosis and are at high-risk of open-heart surgical aortic valve replacement.
Clinicians will test the trial-related implants at University Hospital Bonn in Bonn, Germany, St. George's Hospital in London, and Royal Victoria Hospital in Belfast, Northern Ireland.
Dr Ian Meredith of Monash Medical Centre is the principal investigator, who implanted the first devices in the study.
"We are studying this recapture-enabled valve and low profile delivery system to provide design enhancements that further increase procedural confidence and, ultimately, improve patient care," Dr Meredith said.
Primary endpoints of the study are all-cause mortality and stroke at 30 days, as well as device success rate at 24 hours to seven days.
Secondary endpoints include recapture success rate, when attempted, and haemodynamic performance.
The new system includes CoreValve Evolut R transcatheter valve and the EnVeo R recapturable delivery system, which are currently not approved for commercial use.
The Evolut R transcatheter valve is anatomically designed to provide conformability at the annulus for optimal annular fit and sealing and helps maintain supra-annular valve function for strong haemodynamic performance.
It offers a new InLine Sheath, significantly reducing the profile of the catheter required to access the patient vessel, and its 1:1 delivery response is designed to provide first-time valve placement accuracy during deployment.
Medtronic claims that more than 45,000 patients worldwide have been treated with the CoreValve to date.
The CoreValve system is not approved for commercial use in the US, where it is currently undergoing clinical trials.
According to GlobalData estimates, the transcatheter heart valves market in the US was valued at $280m in 2012 and is expected to grow at a CAGR of 25.3% to reach $1.36bn by 2019.
Image: Medtronic's Mounds View campus. Photo: courtesy of Medtronic Inc.