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.
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.