A Medical Device Daily

St. Jude Medical (SJM; St. Paul, Minnesota) reported regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the Merlin Patient Care System, a universal programmer for cardiac resynchronization therapy (CRT) devices, implantable cardioverter defibrillators (ICDs) and pacemakers.

The system is designed to allow quick and efficient programming at the time of implant and at patients' follow-up visits.

The Merlin is a portable computer that is designed to help physicians efficiently conduct cardiac tests, analyze therapeutic and diagnostic data, and program implanted devices for optimal patient care. St. Jude said physicians can quickly make changes to device therapy through the system's LCD touch-screen to decrease follow-up time.

Patients with ICDs, pacemakers or CRT devices require regular follow-up examinations to ensure that devices are programmed to provide appropriate therapy and to review a patient's response to programmed therapy. If a patient's condition has changed, clinicians can reprogram device parameters with the Merlin system to help protect the patient from abnormal heart rhythms.

"We developed the Merlin Patient Care System by observing clinicians in their working environments," said Eric Fain, MD, president of SJM's Cardiac Rhythm Management Division. "We sought clinicians' input and listened to their needs, then responded by creating an intuitive system that streamlines workflow and simplifies the programming process."

The Merlin system includes a user interface that mimics the natural workflow of a clinic to make it easier for clinicians to operate, as well as enhanced presentation of diagnostics, which consolidates and displays patient information so clinicians can make decisions more quickly.

St. Jude Medical Japan, formerly known in Japan as Getz Bros., has been serving that market since 1925.

Sectra signs Japanese distribution partner

IT and medical-technology company Sectra (Stockholm, Sweden) has signed a distribution agreement with the Japanese company Medical Expert, a provider of medical imaging products. Sectra said Medical Expert is well established in the private and public radiology markets in central and eastern Japan.

Through the partnership, Medical Expert will become a distributor of Sectra's medical systems in Japan. The agreement initially involves Sectra PACS (system for handling radiology images) and Sectra's orthopedic pre-operative planning tool and it may be extended to comprise more products in the future.

The penetration of PACS in Japan, the world's second-largest medical products market, is still relatively low, roughly 25%, and is expected to grow rapidly within the near future.

Torbjörn Kronander, president of Sectra Imtec, said, "This is a strategic move in our efforts to strengthen our position on the Japanese market where we have operated through partners since 1998."

In addition to the distribution agreement, Sectra will open a local branch office in Japan to support partners and customers. The company currently has installations at more than 60 Japanese hospitals.

Parexel expands ownership in India firm

Parexel International (Waltham, Massachusetts) said it has expanded its minority in the clinical pharmacology business of Synchron Research (Ahmedabad, India). The company also reported the sale of a bioanalytical laboratory in Poitiers, France, Synexel Research International, a subsidiary of Synchron.

Parexel's ownership interest in the Ahmedabad Phase I business has increased from 19.5% to 31% on a fully diluted basis, at a cost of about $5 million dollars.

In a separate transaction, Parexel sold the Poitiers business to Synexel Research International for roughly $6.7 million. Staff of the bioanalytical lab in France will join Synchron's bioanalytical business.

Parexel entered into a collaboration with Synchron in 2004, expanding that relationship in 2006 by acquiring a majority stake of Synchron's clinical trials operations in Bangalore, and a minority equity interest in Synchron's Ahmedabad clinical pharmacology business.

In 2007, Parexel opened an office in Hyderabad, India, to offer clients a wide range of clinical research and data management services.

Costa Rica facility for Atek Medical

Atek Medical (Grand Rapids, Michigan), a division of Atek Companies (Minneapolis), reported that it has opened a medical device manufacturing facility in Heredia, Costa Rica.

"With this new investment, Atek Medical has doubled its manufacturing capacity and strengthened its ability to offer unparalleled manufacturing and new product launch services to the medical device industry," said Kay Phillips, president of Atek Companies.

The facility, located in a free trade zone near the San Jose International Airport, will specialize in Class II single-use and electro-disposable device, and Class III implantable device manufacturing. Atek took possession of the building late last year and is currently producing several product lines.

With similar capabilities as Atek Medical's facility in Grand Rapids, the Costa Rica facility is equipped and staffed to provide clients with a complete manufacturing solution.

U.S. firm acquires Chinese research institute

Aida Pharmaceuticals (Santa Monica, California) said it has acquired one of China's top microbiology research institutes, the Jiangsu Institute of Microbiology (JSIM; Wuxi City).

Aida's subsidiary, Hanzhou Aida Pharmaceuticals, acquired 43% of the institute from Jinou Medicine, while another Aida subsidiary, Changzhou Fangyuan Pharmaceutical, acquired an additional 55% from Jiangyin Hi-tech Group.

The transaction is expected to close shortly.

After the completion of the acquisition, Jiangsu Institute of Microbiology will become a subsidiary of Aida Pharmaceuticals.

The U.S. firm said the acquisition is expected to yield multiple new products, including several that already are in clinical trials by China's State Food and Drug Administration.