Feature | October 22, 2013

Medtronic Initiates Clinical Study of Recapturable Transcatheter Valve

heart valve repair medtronic corevalve evolut recapturable

October 22, 2013 — Medtronic Inc. announced the first implants in the CoreValve Evolut R clinical study, which will evaluate the safety and effectiveness of the CoreValve Evolut R recapturable system. This recapture-enabled valve and delivery system is 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).

“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,” said Ian Meredith, M.D., Monash Medical Centre, Southern Health, Melbourne, Australia and principal investigator in the study. Meredith implanted the first devices. “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.”

In addition to Monash Medical Centre, the prospective CoreValve Evolut R 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 University Hospital Bonn in Bonn, Germany; St. George's Hospital in London; and Royal Victoria Hospital in Belfast, Northern Ireland. The primary endpoints 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 hemodynamic performance.

The new system consists of the CoreValve Evolut R transcatheter valve and the EnVeo R recapturable delivery system. The new valve is anatomically designed to provide conformability at the annulus for optimal annular fit and sealing while maintaining supra-annular valve function for strong hemodynamic performance. The EnVeo R delivery system offers a new inline sheath, significantly reducing the profile of the catheter required to access the patient vessel, and its one-to-one delivery response is designed to provide first-time valve placement accuracy during deployment. The new system builds on experience from more than 45,000 CoreValve system implants worldwide.

The CoreValve Evolut R and EnVeo R recapturable system are not currently approved for commercial use. The CoreValve System is not currently approved for commercial use in the United States and is currently undergoing clinical trials.

For more information: www.medtronic.com

Related Content

TAVR, medical guidelines, ACC/AHA, optimization, transcatheter aortic valve replacement
News | Heart Valve Technology| January 18, 2017
The American College of Cardiology recently released new guidance for clinicians and hospitals to use in assessing...
Medtronic, CoreValve Evolut R 34 mm valve, TAVI, CE Mark, European launch
News | Heart Valve Technology| January 17, 2017
Medtronic plc announced the CE (Conformité Européenne) mark and European launch of the CoreValve Evolut R 34 mm valve...
Medtronic, CoreValve Evolut R TAVR system, U.S. IDE Study, TCT 2016
News | Heart Valve Technology| November 03, 2016
Medtronic plc unveiled new clinical data showing that patients treated with the self-expanding CoreValve Evolut R...
SENTINEL trial, transcatheter embolic protection, TCEP, TAVR, stroke, TCT 2016
News | Embolic Protection Devices| November 03, 2016
An international study has found that transcatheter cerebral embolic protection (TCEP) is safe, provides effective...
Medtronic, Harmony TPV, transcatheter pulmonary valve, clinical study results, TCT 2016
News | Heart Valve Technology| November 02, 2016
Medtronic plc recently announced new clinical data for the Harmony Transcatheter Pulmonary Valve (TPV) from its early...
Edwards, Sapien transcatheter heart valve, PARTNER trial, five-year echo data, TCT 2016
News | Heart Valve Technology| November 01, 2016
Edwards Lifesciences Corp. announced new five-year hemodynamic data from the PARTNER Trial demonstrating excellent...
Medtronic, CoreValve Evolut R TAVR system, TCT 2016, FORWARD Study, STS/ACC TVT Registry
News | Heart Valve Technology| October 31, 2016
Medtronic plc presented new positive data from two large registries aimed at evaluating 30-day clinical performance...
Mitralign, Trialign tricuspid repair system, SCOUT I study, 30-day data, TCT 2016
News | Heart Valve Technology| October 28, 2016
Mitralign will present data on its Trialign Tricuspid Repair system at the 2016 Transcatheter Cardiovascular...
Interventional cardiology, cath lab technology, TCT, transcatheter cardiovascular therapeutics
Feature | Cath Lab| October 27, 2016 | Dave Fornell
The volume of information attendees receive at the annual Transcatheter Cardiovascular Therapeutics (TCT) interventio
BioTrace Medical Tempo temporary pacing lead, TAVR
Technology | Heart Valve Technology| October 27, 2016
October 27, 2016 — BioTrace Medical Inc. said it received U.S.
Overlay Init