News | November 26, 2007

St. Jude Medical’s Epic Stented Tissue Valve with Anti-Calcification Technology Receives FDA Approval

November 27, 2007 - St. Jude Medical Inc. announced FDA approval of its Epic Stented Tissue Valve with Linx AC Technology. The Epic Valve, which is identical in design to the company’s Biocor Valve, also incorporates patented anti-calcification technology designed to protect against tissue mineralization, or hardening.

An estimated 100,000 Americans undergo heart valve replacement annually and the majority of them receive tissue valves. Valve durability is affected by both mechanical stress and tissue calcification. The Epic Valve is designed to address both issues to deliver long-term performance.

"The Epic Valve sets a new standard for addressing tissue mineralization and potentially extending long-term valve durability," said Vibhu Kshettry, M.D., director of Cardiac Surgery at the Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, and a principal investigator in the Epic clinical study. "Enhanced durability, combined with a design that facilitates the implant procedure, makes the Epic Valve an ideal prosthesis."

The Epic Valve reportedly features the industry's lowest overall valve height, enhancing implantability. In the mitral position, the valve's low profile reduces the risk of obstructing blood flow into the aorta. In the aortic position, it may provide optimal coronary ostia clearance and reduce the risk of aortic wall protrusion. The new valve will be available in aortic, aortic supra and mitral models.

St. Jude Medical plans to roll out the Epic Valve beginning early 2008.

For more information: www.sjm.com

Related Content

Abbott will end sales of the Absorb bioresorbable stent scaffold, pulling it off the market September 14, 2017.
Feature | Stents Bioresorbable| September 08, 2017 | Dave Fornell
September 8, 2017 — Abbott Vascular has announced it will end commercial sales of its Absorb bioresorbable vascular s
Biotronik's Orsiro Drug-Eluting Stent Outperforms Xience in BIOFLOW-V Trial
News | Stents Drug Eluting| September 01, 2017
September 1, 2017 — Biotronik recently announced data from the BIOFLOW-V randomized trial comparing Orsiro and Xience
FDA Approves Six-Month Primary Endpoint for Tack Endovascular System in Below the Knee Disease
News | Stents Peripheral| July 14, 2017
Intact Vascular Inc. announced the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption...
Onyx DES 2.0 mm stent meets primary endpoints in small vessels
News | June 12, 2017
June 12, 2017 – The Medtronic Resolute Onyx Drug-Eluting Stent (DES) met its primary endpoint of target lesion failur
First Pennsylvania Patient Treated in LEADERS FREE II Trial of BioFreedom Drug-Coated Stent
News | Stents Drug Eluting| May 12, 2017
PinnacleHealth CardioVascular Institute enrolled the first patient in Pennsylvania in a trial assessing the safety and...
Resolute Onyx DES, drug eluting stent, medtronic, gains FDA approval
Technology | Stents Drug Eluting| May 01, 2017
May 1, 2017 — The U.S.
Sponsored Content | Videos | Stents Drug Eluting| May 01, 2017
This video, provided by Medtronic, demonstrates the Resolute Onyx coronary stent.
Tryton Medical, Side Branch Stent, first U.S. commercial case, New York-Presbyterian Hospital, Columbia University Medical Center
News | Stents Bifurcation| March 31, 2017
Tryton Medical Inc. recently announced that the first U.S. commercial case using the Tryton Side Branch Stent was...
Sponsored Content | Videos | Stents Bioresorbable| March 30, 2017
Stephen Ellis, M.D., professor of medicine and director of interventional cardiology at Cleveland Clinic, discusses t
Overlay Init