PARIS – In the face of an expanded scope of scrutiny by French health authorities triggered by the death of the first patient in the pivotal trial for its artificial heart, Paris-based Carmat SA reported the suspension of the clinical study. The company revealed the patient's death "was due to an interruption in the power supply system, following an incorrect battery handling by the patient, as a result of which the prosthesis stopped functioning." Carmat confirmed that the prosthesis functioned correctly, which is consistent with the announcement in November 2016 that "analyses undertaken have not...

PARIS – In the face of an expanded scope of scrutiny by French health authorities triggered by the death of the first patient in the pivotal trial for its artificial heart, Paris-based Carmat SA reported the suspension of the clinical study.

PARIS – A month earlier than expected, Dublin-based Medtronic plc said it has received the CE mark for the Corevalve Evolut R 34 millimeter transcatheter aortic valve implantation (TAVI). The clearance for commercialization in the European Union follows approval by the U.S. FDA in October 2016, and rounds out the top end of the Medtronic TAVI portfolio that includes 23 millimeter, 26 millimeter and 29 millimeter valves. "We look forward to working with physicians across Europe to offer this highly anticipated valve size to the thousands of patients who were previously unable to receive TAVI...