AUSTIN, Texas -- (BUSINESS WIRE) -- On-X® Life Technologies, Inc. (On-X LTI) announced today that under an agreement with SynCardia Systems, Inc. (SynCardia) and as part of the On-X Contract Manufacturing Business Unit, On-X LTI is producing SynHall valve components for the SynCardia Total Artificial Heart.
Total Artificial Heart with SynHall Valves. Valves produced by On-X Life Technologies, Inc. Photo courtesy: syncardia.com
SynCardia recently received FDA approval for the SynCardia temporary Total Artificial Heart with the SynHall valve produced by On-X LTI. Derek Southard, COO for On-X LTI, stated, "We are so pleased that SynCardia has received the FDA approval. We see this as a natural part of our contract manufacturing business and are grateful to play an important role in the SynCardia Total Artificial Heart, which is so vital to the well-being of so many patients. The achievement of the FDA approval is a result of a very cooperative relationship between the product teams from both SynCardia and On-X LTI. The speed with which this was accomplished is unprecedented in medical device history."
Michael Garippa, CEO and President of SynCardia, commented "SynCardia is fortunate to have a manufacturing partner of On-X LTI's level of valve expertise and product development efficiency. We look forward to a long and productive relationship with On-X LTI."
On-X LTI offers a range of cardiac products that are designed to significantly improve the quality of life of patients including mechanical heart valves for aortic and mitral valve replacements, the Chord-X™ ePTFE Suture for chordal replacement and repair and the CarbonAid™ and CarbonMini™ CO2 Diffusion Devices designed to prevent air embolism during open-heart surgery. The On-X LTI Contract Manufacturing Business Unit offers technical services in carbon based technology including medical device design, product development and manufacturing. Headquartered in Austin, Texas, On-X LTI is a privately held company.
More information: www.onxlti.com.
About SynCardia Systems, Inc.
SynCardia, based in Tucson, Arizona, is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart. The SynCardia temporary Total Artificial Heart is approved for use as a bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.
More information: www.syncardia.com.
On-X is a registered trademark of On-X Life Technologies Inc. All other trademarks mentioned herein belong to their respective companies.