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.
