U.S. FDA Grants Expanded Labeling Claim to On-X Life Technologies, Reducing Blood-Thinning Requirements for Heart Valve Patients Thousands With On-X Aortic Implant May Be Able to Reduce Medication Regimen AUSTIN, TX — April 2, 2015 — Thousands of Americans with On-X® Aortic Heart Valves may be able to reduce their regular blood-thinning medication regimen, thanks to […]
On-X LTI Receives FDA Approval
February 26, 2013 By
On-X Heart Valve with Anatomic Shaped Sewing Ring The On-X Aortic Heart Valve with an anatomic shaped sewing ring matches the shape of the native aortic annulus and helps prevent flattening and distortion AUSTIN, TX – February 26, 2013 – On-X® Life Technologies, Inc. (On-X LTI) announced today that it has received approval from the […]
On-X Life Technologies Submits for FDA/CE Approval
October 22, 2012 By
Reduced Anticoagulation Indication for On-X Aortic Heart Valve If approval is received, the On-X valve will become the first aortic valve that allows patients to be maintained at levels of anticoagulation below currently recommended professional society guidelines, helping to lessen anticoagulation – related complications AUSTIN, TX – October 22, 2012 – On-X® Life Technologies, Inc. […]
On-X Heart Valve Shows Safety with Reduced Blood Thinners
April 5, 2011 By
On-X Heart Valve Shows Safety with Reduced Blood Thinners Early Data Reported From Large FDA IDE Clinical Trial is Encouraging New Orleans, LA — April 5, 2011 – Patients with a mechanical heart valve need lifelong treatment with blood-thinning drugs like warfarin − anticoagulants that prevent blood from clotting on the man-made material but also […]
On-X LTI Receives FDA Approval for AAP
January 21, 2011 By
On-X LTI Receives FDA Approval for Aortic Valve with Vascutek Graft Innovative On-X aortic valve is now available with market-leading pre-attached Gelweave Valsalva™ Vascular Prosthesis AUSTIN, TX — January 21, 2011 — On-X® Life Technologies, Inc. (On-X LTI) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market […]
US FDA Mitral Valve Approval
March 6, 2002 By
The U.S. FDA issues premarket approval for the On-X mitral valve AUSTIN, TX — March 06, 2002 – The U.S. FDA issues premarket approval for the On-X mitral valve. All On-X valves are now available in the United States.
US FDA Aortic Valve Approval
May 30, 2001 By
MCRI is awarded FDA premarket approval for its On-X aortic valve AUSTIN, TX — May 30, 2001 – MCRI is awarded FDA premarket approval for its On-X aortic valve, making the valve available to patients in the United States. Mitral valve approval is expected to follow pending additional follow-up.
US Clinical Trials Expand
December 1, 1998 By
MCRI to expand the number of clinical centers for the On-X valve FDA study AUSTIN, TX — December 01, 1998 – The U.S. Food and Drug Administration granted unconditional Investigational Device Exemption (IDE) that allows MCRI to expand the number of clinical centers for the On-X valve FDA study in the United States. This IDE […]
