Press Release
On-X LTI Enters License and Development Agreement
On-X Life Technologies Enters License and Development Agreement with Cleveland Clinic Surgical System to Repair Mitral Valve Chordae System is intended to improve mitral valve repair and simplify procedure for cardiac surgeons AUSTIN, TX — December 8, 2009 — On-X® Life Technologies, Inc. (On-X LTI), manufacturers of the On-X® Prosthetic Heart Valve announced today that…
Read MoreOn-X LTI Completes Enrollment
On-X Life Technologies Completes Enrollment in High-Risk Patient Group Low Anticoagulation Trial Data from the PROACT Trial may provide evidence that the On-X valve may be appropriately maintained at lower levels of anticoagulation AUSTIN, TX — October 20, 2009 — On-X® Life Technologies, Inc. (On-X LTI), manufacturers of the On-X® Prosthetic Heart Valve and On-X®…
Read MoreOn-X LTI Doubles Manufacturing Space
On-X Life Technologies Doubles Manufacturing Space in Austin Increasing demand for On-X Prosthetic Heart Valve and orthopedic implant products make capacity expansion necessary AUSTIN, TX — March 20, 2009 — On-X® Life Technologies, Inc. (On-X LTI), manufacturers of the On-X Prosthetic Heart Valve and On-X carbon products for orthopedic implants, announced today that it is…
Read MoreOn-X Valve Reduced Anticoagulation Clinical Trial
FDA approved an investigational device exemption clinical trial of the On-X Prosthetic Heart Valve Successful completion of the clinical study could result in the On-X valve becoming the only mechanical heart valve approved for low-dose anticoagulation therapy. AUSTIN, TX — January 13, 2006 — The U.S. Food and Drug Administration (FDA) has approved an investigational…
Read MoreLow Postoperative Complications with On-X Valve
Clinical Study Reinforces Low Postoperative Complications with On-X Valve AUSTIN, TX — June 25, 2003 — Medical Carbon Research Institute, L.L.C. (“MCRI”), manufacturer of the On-X(R) Prosthetic Heart Valve, announced the presentation of clinical study results comparing rates of late complications (thrombosis, major bleeding and major thromboembolism) for the On-X valve and competing valves within…
Read MoreAustralian TGA Approves On-X Valves
The Australian Therapeutic Goods Administration announce the inclusion of On-X valves AUSTIN, TX — March 14, 2002 – The Australian Therapeutic Goods Administration announce the inclusion of On-X valves in the Australian Register of Therapeutic Goods. On-X valves are now available in Australia and New Zealand.
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 MoreMedical Design Excellence Award
MCRI Named Winner of Medical Design Excellence Award AUSTIN, TX — March 01, 2002 – CANON COMMUNICATIONS LLC announced MCRI a winner of the fifth annual Medical Design Excellence Awards (MDEA) competition in the “Implant and Tissue-Replacement Products” category.
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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