EVAHEART MEDICAL USA, INC. (EMUSA) was established in October, 2002 in Pittsburgh, PA as a wholly owned subsidiary of SUN MEDICAL TECHNOLOGY RESEARCH CORPORATION (Sun Medical) in order to prepare the clinical trials in the United States for Sun Medical’s EVAHEART LVAS (Left Ventricular Assist System). Once the device is approved by the FDA, the company will function as a distributor and provide customer support for the EVAHEART LVAS in the US.

Sun Medical was established in 1991 in Suwa City, Nagano, Japan to develop the EVAHEART LVAS under the license of Dr. Kenji Yamazaki of Tokyo Women’s Medical University. The company, along with Dr. Yamazaki, collaborated with the University of Pittsburgh on a series of animal experiments to verify system performance and design improvements. Sun Medical realized the importance of both the LVAS market in the United States and FDA approval of the product. Therefore, once testing demonstrated compliance with performance objectives and the design was frozen, Sun Medical sought to establish a presence in the United States. Because of its relationship with the University, it was natural for the company to establish in Pittsburgh.

The Suwa area has been recognized as the capital of precision industry in Japan. Now, with unique technologies in micro machining and electronics established in the area (in companies such as SEIKO and EPSON), Sun Medical has a mission to develop and commercialize medical devices which save lives and improve the health of patients around the world. In order to achieve the mission, the company realized the need to improve the current technologies. It has collaborated with many groups in the industry as well as others in academic institutions and governmental agencies to achieve this goal.

Currently, Sun Medical is preparing for the initial phase of the EVAHEART LVAS clinical trial in Japan. The clinical data generated by this initial trial will be referenced in the Investigational Device Exemption (IDE) submission to the FDA. Once the IDE has been approved, EMUSA will initiate a feasibility study in the US.

EMUSA brings clinical, regulatory and engineering expertise to work closely with Sun Medical, not only for the technical information needed for the IDE submission but also as a unified team to establish a sound quality system for such a critical product.