4C Medical Plans First Early Feasibility Study For An Implantable In Japan

4C Medical plans to conduct both an early feasibility study and the pivotal trial for its mitral regurgitation treatment device simultaneously in Japan, the US and Canada. The company says the study is the first early feasibility study in Japan for an implantable device.

American and Japanese Flags waving against blue Sky
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Start-up mitral valve regurgitation treatment firm 4C Medical Technologies is preparing for the first early feasibility study of an implantable device to be conducted in Japan, company President and CEO Bob Thatcher said March 5 at the Cardiovascular Research Technologies (CRT) annual conference in Washington, DC.

A long-running collaboration between US FDA and the Japanese Pharmaceutical and Medical Device Agency (PMDA) known as Harmonization by...

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