September 7, 2009
Asahi Kasei Corp.
Misuzu & Sun Medical Holdings Co., Ltd.

US Clinical Study Approval for the Evaheart™ LVAS
Evaheart Medical USA, Inc. (EMUSA), joint venture of Asahi Kasei and Sun Medical Technology Research Corp. (Sun Medical), has received conditional approval of an investigational device exemption (IDE) from the United States Food and Drug Administration (FDA) to begin enrollment in a US clinical study of the Evaheart™ left ventricular assist system (LVAS) for a Bridge-to-Transplant (BTT) indication in patients with end-stage heart failure.

EMUSA will address the conditions from the FDA letter before arranging for the clinical study. The approval limits the clinical trial to 20 subjects and up to 20 clinical sites. Supplemental approval is necessary to continue a larger pivotal study. It is expected that the first implantation of Evaheart™ LVAS will be done in the first quarter of 2010.
About Evaheart™
  Evaheart™ is the only implantable LVAS made in Japan, developed by Sun Medical in cooperation with universities including Tokyo Women's Medical University, Waseda University, and University of Pittsburgh. The system features flow capabilities exceeding 10 lpm and has demonstrated pump durability in the Japanese clinical trial.
Evaheart™ is a trademark of Sun Medical Technology Research Corp.


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