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.”
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