Feature | February 28, 2013

Medtronic Gains European Approval for Engager Transcatheter Valve

New Valve Provides Transapical Option for Physicians Treating Patients with Aortic Stenosis

Engager TAVI valve


February 28, 2013 — Medtronic Inc. announced European CE (Conformité Européenne) mark approval for its Engager Transcatheter Aortic Valve Implantation (TAVI) System with transapical delivery catheter. The system is indicated to treat patients with severe aortic stenosis who are at high or extreme risk for surgical aortic valve replacement (SAVR).

The new valve demonstrated positive clinical outcomes in its European Pivotal Trial. Results from the multi-center trial, which were presented during late-breaking trial sessions at the recent European Association for Cardio-Thoracic Surgery and the Society of Thoracic Surgeons annual meetings, revealed high rates of procedural success, minimal paravalvular leak (PVL) and continuing clinical benefits for patients over time.

In the trial, the Engager valve was delivered transapically and had 94.3 percent overall device success (according to Valve Academic Research Consortium modified definitions). There were no procedures requiring a second valve and no occurrences of valve embolization, coronary obstruction or device malposition. No patients had moderate or severe PVL at six months, as measured by an independent echocardiography core lab. In addition, while most patients (88 percent) were NYHA Class III or IV at baseline, at six months 82 percent of patients had improved to NYHA Class I or II.

“The Engager valve has demonstrated exceptional clinical results, and by adding it to our transcatheter valve portfolio, we are providing heart teams with more options for achieving the best outcomes for every patient with severe aortic stenosis,” said John Liddicoat, M.D., senior vice president of Medtronic and president of the Medtronic structural heart business.

The Medtronic Engager System is not available in the United States.

The Engager valve uses a minimally?invasive delivery system via a catheter inserted in the apex (the lower, pointed end) of the heart. The valve is comprised of bovine tissue leaflets and a self?expanding nitinol frame designed to promote annular sealing to minimize paravalvular leak. Control arms simplify implantation, and the supra-annular valve positioning facilitates leaflet coaptation (connections) in non-circular anatomy for optimal hemodynamic performance. A direct aortic delivery system for Engager will be introduced in the future.

For more information: www.medtronic.com


Related Content

News | Heart Valve Repair| November 23, 2015
NaviGate Cardiac Structures Inc. (NCSI) announced that a first-in-human implant of its catheter-guided, mitral-valved...
News | Blood Testing| November 18, 2015
Konica Minolta Inc. announced that it has developed the SPFS Immunoassay System, capable of highly sensitive...
Neovasc, Tiara, transcatheter mitral valve, TMVR

The Neovasc Tiara transcatheter mitral valve is currently being tested in U.S. and international clinical trials. 

Feature | Heart Valve Repair| November 12, 2015 | Dave Fornell
The advent of transcatheter valve repair and replacement technologies is one of those rare instances where there is a
MC3 Cardiopulmonary, acquisition, Terumo Cardiovascular Systems, new manufacturing facility, surgical cannula

Image courtesy of MC3 Cardiopulmonary

News | Cardiovascular Surgery| November 10, 2015
MC3 Cardiopulmonary announced it has completed the acquisition and transfer of all assets associated with Terumo...
SALUS trial, Direct Flow Medical TAVR device, Medtronic CoreValve, PinnacleHealth CardioVascular Institute

Image courtesy of Direct Flow Medical

News | Heart Valve Repair| November 10, 2015
PinnacleHealth CardioVascular Institute enrolled the first patient in Pennsylvania in a randomized trial studying a new...
Sponsored Content | Videos | TCT| November 05, 2015
DAIC Editor Dave Fornell offers his choices for the most innovative new interventional cardiovascular technologies pr
Sponsored Content | Videos | TCT| November 05, 2015
Tom Watson, clinical analyst for MDBuyLine, and DAIC Dave Fornell discuss some of the technology trends at the 2015 T
News | Heart Failure| November 02, 2015
Medical device developer Cardionomic Inc. announced that it has received $20 million in Series A financing. Investors...
Sponsored Content | Videos | Heart Failure| October 30, 2015
Manesh Patel, M.D., associate professor of medicine, and director of interventional cardiology and the cath labs at D
St. Jude Medical, HeartMate 3 LVAD System, CE Mark approval, left ventricular assist device

Image courtesy of St. Jude Medical

News | Ventricular Assist Devices (VAD)| October 28, 2015
St. Jude Medical Inc. announced the company has received CE Mark approval for the HeartMate 3 Left Ventricular Assist...
Overlay Init