On-X Life Technologies, Inc. (On-X LTI) was formerly
Medical Carbon Research Institute (MCRI).
Newsroom
On-X Life Technologies Enters License and Development Agreement with Cleveland Clinic for Surgical System to Repair Mitral Valve Chordae
- Wednesday December 8, 2009
Austin-based On-X Life Technologies, Inc. (On-X LTI), manufacturers of the On-X® Prosthetic Heart Valve, announced today that it has entered into an exclusive worldwide license with the Cleveland Clinic for a system of products intended to improve and simplify the replacement of damaged or severed mitral valve chordae. The system is the creation of co-inventors A. Marc Gillinov, M.D., a staff cardiac surgeon at Cleveland Clinic, and Michael K. Banbury, M. D., of Christiana Care’s Center for Heart and Vascular Health, and will be co-developed with the On-X LTI New Product Development team. (full story)
On-X Life Technologies Completes Enrollment in High-Risk Patient Group of Low-Anticoagulation Trial
- Tuesday, October 20, 2009
Austin-based 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 enrollment in the High-Risk Patient Group of the landmark PROACT (Prospective Randomized On-X Anticoagulation Clinical Trial) is complete. While data is still to be analyzed, it is a positive indication that the trial has reached full enrollment of the High-Risk Aortic Valve Replacement Patient Group without an adverse incident that would lead the study’s Data Safety Committee to conclude the study prematurely. (full story)
On-X Life Technologies Doubles Manufacturing Space in Austin
- Friday, March 20, 2009
Austin-based 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 doubling the size of its manufacturing space in Austin. The expansion is a result of increased demand for On-X LTI products in both the cardiac surgery and orthopedic markets. The company has signed a lease for a 40,405 square foot building at 1300 East Anderson Lane, Austin, Texas, that was previously used by Sorin Carbomedics. On-X LTI will begin a 19-month transition from its present site at 8200 Cameron Road to the larger facility this week. (full story)
On-X Valve Reduced Anticoagulation Clinical Trial
- Tuesday, January 10, 2006
The U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) clinical trial of the On-X Prosthetic Heart Valve at reduced anticoagulation levels following review and approval by clinical centers. 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. (full story)
MCRI Forms Strategic Alliance with QAS for Self-Monitoring of Anticoagulation by On-X Heart Valve Patients
- Tuesday, August 23, 2005
Partnership will provide tools to On-X valve recipients to improve anticoagulation levels and encourage better self-monitoring. (full story)
Clinical Study Reinforces Low Postoperative Complications with On-X Valve- Wednesday, June 25, 2003
Study in South Africa evaluates On-X valve performance in a population that includes a high percentage of patients with inadequate anticoagulation therapy compliance. (full story)
Australian TGA Approves On-X Valves
- Thursday, 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. (full story)
U.S. FDA Mitral Valve Approval
- Wednesday, 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. (full story)
MCRI Named Winner of Medical Design Excellance Award
- Friday, 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. (full story)
U.S. FDA Aortic Valve Approval
- Wednesday, 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. (full story)
U.S. Clinical Trials Expand
- Tuesday, 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 supercedes the conditional IDE granted in Spectember, 1997. (full story)
E.U. Grants CE Mark for the On-X Valve
- Friday, July 24, 1998
The TUV in Munich, Germany granted CE Mark for the On-X valve. The valves are now available for use in countries of the European Union. (full story)