Carmat To Launch Total Artificial Heart In Early 2021
After years of setbacks, the company will launch its device in Europe as a bridge to transplant in heart failure patents.
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Carmat suspended the production of its Total Artificial Heart while it strengthens certain manufacturing processes.
SynCardia Systems' Freedom Driver System was subject to a class I recall last year, and now US FDA has updated its concerns about a component of the firm's Temporary Total Artificial Heart based on post-approval study data, and is asking that malfunctioning drivers be returned to the manufacturer.
Carmat has taken another step towards approval of its biocompatible artificial heart after developing a portable console that has allowed one patient implanted with the system to return home.