Health News

Factbox: Europe's lead over U.S. on heart device approvals

(Reuters) - U.S. cardiologists have become increasingly frustrated by lengthy delays in approvals of medical technology used in heart procedures, often coming three years or more after European approvals.

The following are some heart-related devices in use in Europe that are either awaiting U.S. approval or were approved in the United States long after becoming available to European patients. CE Mark is the designation for European approval.

* Sapien Transcatheter Aortic Valve System by Edwards Lifesciences

CE Mark September 2007

FDA Approval October 2011

* Sapien XT (improved 2nd generation version of Sapien)

CE Mark Europe, March 2010

Still undergoing FDA mandated clinical trials

* CoreValve (transcatheter heart valve system) by Medtronic

CE Mark May 2007

FDA Approval under review

* Symplicity Renal Denervation System by Medtronic

CE Mark April 2010

FDA Approval under review

* Arctic Front Catheter Ablation for Atrial Fibrilation (first generation) by Medtronic

CE Mark July 2005

FDA Approval December 2010

* MitraClip (to stop heart valve leakage) by Abbott Laboratories

CE Mark March 2008

FDA Approval under review

* Amplatzer Occluder PFO Closure System (fixes small hole in heart) by St. Jude Medical

CE Mark 1998

FDA Approval under review

* Watchman Left Atrial Appendage Closure Device (for atrial fibrillation) by Boston Scientific

CE Mark 2005

Company to file for U.S. approval in current quarter

* HeartMate II Left Ventricular Assist Device by Thoratec Corp

CE Mark November 2005

FDA Approval (as bridge to heart transplant) April 2008

Compiled by Debra Sherman and Bill Berkrot; Edited by Douglas Royalty