Posts Tagged ‘fda’
FDA Approval: On-X aortic valves with less warfarin
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…
Read MoreOn-X LTI Receives FDA Approval
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…
Read MoreOn-X Life Technologies Submits for FDA/CE Approval
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.…
Read MoreOn-X Heart Valve Shows Safety with Reduced Blood Thinners
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…
Read MoreOn-X LTI Receives FDA Approval for AAP
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…
Read MoreUS FDA Mitral Valve Approval
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.
Read MoreUS FDA Aortic Valve Approval
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.
Read MoreUS Clinical Trials Expand
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…
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