A Medical Device Daily

American Medical Systems (AMS; Minnetonka, Minnesota) said it has received clearance from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market and distribute its AMS 800 artificial urinary sphincter in Japan. According to the company, the device that is implanted and completely concealed inside the patient's body.

AMS says the device effectively controls the flow of urine and restores continence. The first-of-its-kind product in Japan offers incontinent patients an alternative to traditional pad and diaper therapy, the company noted.

The AMS 800 has been used for nearly 30 years to restore urinary continence in almost 130,000 patients around the world, according to the company. The long-term safety and efficacy of the AMS 800 have made it the gold standard treatment for moderate to severe stress urinary incontinence, which can be an unfortunate side effect of prostate cancer surgery. According to a recent survey conducted by the Japanese Urological Association, nearly 16,000 radical prostatectomies were performed in Japan in 2004.

"We are very excited to offer this treatment to incontinent men in Japan," said Michael Ryan, VP and general manager of Asia Pacific, Latin America and Canada at AMS. "Although the incidence of prostate cancer is lower in Japan than in the West, it is on the increase."

AMS said it is currently working with a select group of physicians to develop Centers of Excellence throughout Japan, which will serve as resources and training centers for physicians interested in implanting the AMS 800. As a next step, the company said it would seek to obtain national reimbursement through the MHLW Insurance Bureau.

"We are very grateful to the Japanese Urological Association and Japanese Neurogenic Bladder Society for recognizing the importance of the AUS," Ryan said. "AMS is eager to begin working with our identified Centers of Excellence as we strive to offer this product to every Japanese patient whose quality of life could be improved through the use of this technology."

Perot inks pact with Changsha for platform

Perot Systems (Plano, Texas) has signed a healthcare information technology agreement with the Changsha Municipal Government in the Hunan Province of China. The agreement calls for Perot Systems to develop a plan for a city-wide Regional Health Information Platform, and it includes coordination of planning for healthcare data centers and the creation of electronic health records for city residents.

SIRO expands India facility

SIRO Clinpharm (Mumbai, India), a global contract research organization, reported expansion of its clinical trials supplies facility in Mumbai. This expansion has been fueled by a demand by pharmaceutical and biotech companies for storage and distribution of clinical trial supplies, the company said.

"We opened our clinical trials supplies warehouse in 2003 with a modest area of 1,800 square feet," said Jayanti Vaidyanath, VP of administration, legal & clinical trials supplies management. "Those days we were one of the few CROs based out of India to have such a facility. Now, with the expanded facility, we have a bigger area of 6200 square feet with room for further expansion."

Dr. Ajit Nair, president of India operations, said the expansion would enable the company to handle more orders, thus increasing its ability to serve a wider client base.

Health Robotics in distribution with Grifols

Health Robotics (Bolzano, Italy) said it has signed an exclusive five-year strategic partnership with Grifols International (Barcelona, Spain) for its CytoCare Robot. The agreement enables Grifols to add CytoCare to its prior i.v.STATION contract with Health Robotics, and achieve its objective to safely, accurately and cost-effectively automate the preparation of Oncology I.V. Admixtures in Mexico, Chile, Brazil, Argentina, Uruguay, Paraguay, Bolivia, Peru, Venezuela, Colombia, Ecuador, Panama, Costa Rica, Belize, Nicaragua, El Salvador, Honduras, Guatemala, Surinam, French Guyana, and Guyana. In addition, the contract between the companies also adds Mexico to Grifols' i.v.STATION distribution and support rights after Health Robotics recently accomplished the termination of its last Devon Robotics (King of Prussia, Pennsylvania) contract, the company said.

"We are very excited to have been chosen by Health Robotics as their exclusive CytoCare partner in Latin America, and to add one of the largest Latin American markets [Mexico] to our i.v.STATION distribution rights. CytoCare, the world's first and only robotic system designed for the safe and sterile preparation of patient-specific hazardous IV Admixtures, represents an ideal complement to our other market-leading Pharmacy Automation products. Health Robotics' two products will help our local service teams in Latin America differentiate our pharmacy solutions from both clinical and financial perspectives," said Xavier Guix, VP of marketing for Grifols' Hospital System Division.

Sectra enters the Saudi Arabian market

Sectra (Link ping, Sweden) said it has signed a distribution agreement with medical technology company Attieh Medico (Jeddah, Saudi Arabia).

Through this partnership, Attieh Medico has become a distributor of Sectra's medical systems in Saudi Arabia. The agreement includes all of Sectra's products within medical systems, including Sectra MicroDose Mammography and Sectra PACS (system for processing and archiving of digital radiology images).

"Attieh Medico is a very professional medical equipment distributor with a solid position and an established customer base in the Saudi Arabian market," said Brian Selman, VP of International Operations at Sectra. "They will be an excellent partner for us as we now enter one of the largest and most technologically advanced markets in the Middle East."

Sectra makes IT-systems and products for radiology, mammography and orthopedic departments.

PRA opens Milan office

PRA International (Raleigh, North Carolina), a clinical research organization, said it is opening a new office in Milan, Italy. PRA has operated in Italy since 2003 through home-based PRA staff, the company noted. During the past three years alone, PRA has participated in more than 80 studies spanning 13 therapeutic areas in Italy.

"We are pleased to continue our global expansion with the opening of the Milan office," said Ludger Langer, PRA VP of Clinical Operations - Europe, Asia-Pacific, Africa. "This opening, along with PRA's other expansions around the world, is helping us to meet the increased needs and demands of our customers. The Milan facility provides additional infrastructure for our existing staff in Italy and enables future staff expansion dictated by customer needs."

Lucia Dolfi, director of Clinical Operations, heads the PRA Milan office.