US-based Medtronic has announced the first implantations of its CoreValve Evolut R recapturable system as part of a clinical study.
CoreValve Evolut R recapturable system has CoreValve Evolut R transcatheter valve and EnVeo R recapturable delivery system.
The CoreValve Evolut R clinical study is designed to assess the safety and effectiveness of the company’s CoreValve Evolut R recapturable system.
In addition to Monash Medical Centre, the clinical study will enroll up to 60 patients with severe symptomatic aortic stenosis who are considered at high risk for open-heart surgical aortic valve replacement at three hospitals in Germany, UK, and Ireland.
All-cause mortality, stroke at 30 days, and device success rate at 24 hours to seven days are the primary endpoints.
Recapture success rate and hemodynamic performance are the secondary endpoints of the study.
Monash Medical Centre – Southern Health director Dr Ian Meredith, who is a principal investigator and implanted the first devices in the study, noted CoreValve has set a high bar for rates of procedural success, which have been confirmed in both real-world use and clinical studies such as CoreValve ADVANCE.
"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 added.
CoreValve Evolut R and EnVeo R recapturable systems are not currently approved for commercial use.
CoreValve system is currently undergoing clinical trials and is not currently approved for commercial use in the US.