TCTMD

Medtronic CoreValve® System Gains First Approval for Transcatheter Valve-In-Valve Procedures

MINNEAPOLIS - Medtronic, Inc. today announced it has received Conformité Européenne (CE) Mark for valve-in-valve (VIV) procedures using the CoreValve® and CoreValve® Evolut(TM) transcatheter aortic ...
TCTMD

Single-Center Experience Shows Evolution of CoreValve Procedure Over Time

As clinicians have gained experience with transcatheter aortic valve implantation (TAVI) using the CoreValve system, the procedure has become safer—with fewer severe bleeds and cerebrovascular ...
FierceBiotech

Medtronic wins CE mark to implant CoreValve using expanded procedure

Medtronic ($MDT) scored a pivotal CE mark that will help expand the market for its CoreValve transcatheter aortic valve replacement (TAVR). This latest regulatory nod ...
Medgadget

Medtronic CoreValve EU Cleared for Transcatheter Valve-In-Valve Procedures

Natural aortic valves are subject to a great deal of physical stress. After decades, they can become stenosed or incompetent, but the prostheses that replace them end up being subjected to the same ...
Medscape

CoreValve Approved for Valve-in-Valve Replacement Procedures

SILVER SPRING, MD — The US Food and Drug Administration (FDA) has expanded the indication for the CoreValve System (Medtronic, Minneapolis, MN) to include aortic "valve-in-valve" replacement ...
Nasdaq

Study Shows Medtronic's CoreValve TAVR Device Has Consistent And Cost Effective Performance

Medtronic, Inc. 's ( MDT) CoreValve transcatheter aortic valve replacement (TAVR) system continues to provide efficient treatment at two years for extreme-risk patients, the company announced at the ...
Medscape

First percutaneous implants of CoreValve encouraging, but many caveats remain

Siegburg, Germany - Percutaneous implantation of the self-expanding CoreValve aortic valve bioprosthesis in the first-ever series of patients shows that the procedure is feasible in those deemed too ...
MD&M East

Medtronic Wins First Ever Regulatory Approval for TAVI for Valve-In-Valve Procedures

Medtronic announced Thursday that the company has received a CE Mark for valve-in-valve procedures using its CoreValve and CoreValve Evolut transcatheter aortic valve implantation system. It is the ...
News Medical

U-M implants CoreValve Evolut R System in patients with severe aortic stenosis

The University of Michigan Frankel Cardiovascular Center is one of the first hospitals in the country to implant Medtronic's new investigational device during transcatheter aortic valve replacement ...
Local News 8

PMC doctors perform state’s first CoreValve procedure

The Portneuf Medical Center is the first hospital in Idaho to replace a heart valve using the newest, cutting-edge technology known as the Medtronic CoreValve. This is different from the regular ...
BioWorld

FDA approves Medtronic's CoreValve for transcatheter VIV procedures

The FDA has approved, for the first time, a transcathter heart valve for valve-in-valve (VIV) procedures in patients whose surgical aortic heart valves have failed. The agency expanded the approved ...
Forbes

FDA Issues Warning Letter To CoreValve Investigator

(Updated) The FDA has issued a warning letter to an investigator in the Medtronic CoreValve US Pivotal Trial. The letter cites numerous serious violations relating to the treatment of subjects in the ...