A Medical Device Daily

Terumo Heart (Ann Arbor, Michigan) said the first DuraHeart Left Ventricular Assist System (LVAS) was implanted last month at the University of Tokyo Hospital.

Its parent company, Terumo Corp., said it will continue its efforts toward an early application for approval for manufacture and sales in Japan.

Terumo’s LVAS is a third-generation LVAS combining a centrifugal pump with a magnetically levitated impeller. The product received the CE mark in Europe in 2007 and began its U.S. pivotal trial in July.

The Mag-Lev centrifugal pump technology was developed by Dr. Akamatsu, former professor of the faculty of engineering at Kyoto University (Kyoto, Japan), in collaboration with NTN Corp.

The development base was moved to the U.S. in 2000 to continue product development and commercialization efforts.

The company noted that the Japanese Ministry of Health, Labor and Welfare has highlighted implantable left ventricular assist devices in its “Early Introduction of Medical Equipment with Medical Needs” program.

Terumo’s focus is the development of products to improve the quality of healthcare for heart failure patients. Terumo is a manufacturer of a wide array of medical products.

At present, DuraHeart is limited to investigational use only in the U.S., and is CE-marked in Europe.

Asian product launch by Camstar

Camstar (Charlotte, North Carolina), said it is launching its Medical Device Suite – already widely deployed at device companies in the U.S. and Europe – in China, Japan, Singapore and Taiwan.

The company said regulatory bodies, in particular in the U.S. and Europe, “are dramatically increasing oversight of import safety and supplier quality. As global medical device manufacturers outsource more of their manufacturing operations to the Asia Pacific region, they must require complete visibility into critical quality and manufacturing metrics.”

Camstar added that Asian medical device manufacturers “are faced with intense scrutiny around products destined for Western markets and must effectively demonstrate that their quality systems and manufacturing processes are fully compliant with all required regulations and mandates.”

The company said its Medical Device Suite, built on its Enterprise Manufacturing and Quality platform, “facilitates compliance in global manufacturing companies by providing full manufacturing control and traceability, and allows companies to build the foundation for quality that can be scaled across their enterprise.”

It said Medical Device Suite “helps manufacturers reduce costly errors, scrap and rework, and eliminates redundant paperwork checks. The audit trail, the basis of the electronic Device History Record, is accessible globally for traceability and effective root-cause analysis.”

Manash Chakraborty, general manager, Asia-Pacific, said, “One of Camstar’s key advantages is wide acceptance in North America and Europe. Top global medical device manufacturers are already running on Camstar’s solutions – these are the companies that many Asia-Pacific manufacturers are targeting as potential customers. Product safety, brand protection and customer confidence are prime concerns.”

Big order for Siemens in South Korea

Siemens Healthcare (Erlangen, Germany) reported landing a large order in South Korea, with the new Pusan National University Hospital (PNUH) in Yangsan scheduled to receive 44 medical systems from Siemens. The order is valued at $20 million.

The hospital also has signed a service contract with Siemens that includes maintenance and constant remote monitoring of the systems.

The company noted that plans are being made to boost medical care in and around Pusan, whose 3.7 million inhabitants makes it South Korea’s second-largest city. In order to accommodate the improvement plan, Pusan National University Hospital is building an additional hospital in Yangsan, a city under development 35 kilometers from Pusan.

For the new hospital complex, Siemens Healthcare will supply the radiology, nuclear medicine, oncology, cardiology and emergency care units with systems including MRI, CT, angiography, X-ray and fluoroscopy, as well as ultrasound units and systems for nuclear medicine and mammography.

PNUH Yangsan will offer more than 1,700 beds and comprise seven specialist hospitals, including a university hospital, a children’s hospital, a dental hospital, a hospital for oriental medicine and a pre-medicine school.

Some subsections will admit patients this month, while plans call for the entire hospital complex to open for full operation in 2011.