A Medical Device Daily

Stryker (Kalamazoo, Michigan) is taking a first step into the Chinese marketplace with the establishment of a manufacturing plant in Suzhou, in the eastern part of the country.

According to a story late last week in the Kalamazoo Gazette, Stryker CEO Stephen MacMillan revealed the new plant, which will manufacture instruments used in orthopedic-implant surgeries, during the question-and-answer period at the company's shareholder meeting last week.

In response to a shareholder question on foreign investment, MacMillan said the medical-technology company is looking to further expand its presence around the world.

"We certainly are expanding our manufacturing footprint and our selling operations around the world," he said. "Right now, most of our manufacturing today resides both in North America and in Western Europe. But as we go to the future, we have broken ground on a plant in China . . . to serve the Chinese marketplace and potentially that part of the world."

In a company statement, Stryker said: "As part of its strategic expansion into the Asia Pacific region, Stryker Corporation, a global leader in the medical device industry, will open a plant in China. The facility, which will be located in Suzhou Industrial Park, will initially produce manual instrumentation used in orthopaedic implant surgery. The plant is expected to be operational in 2009.

"Suzhou Industrial Park provides a state-of-the-art manufacturing environment that is currently home to more than 75 facilities operated by global Fortune 500 companies. The Suzhou Industrial Park is a unique joint venture between the governments of the People's Republic of China and Singapore. Because of Stryker's commitment to environmental sustainability, this facility will be planned and built to achieve Leadership in Energy and Environmental Design (LEED) certification."

Suzhou is located about 80 miles west of Shanghai.

New unit in Japan for Aperio

Aperio Technologies (Vista, California), a global provider of digital pathology for the healthcare and life sciences industry, said it has expanded its international presence with a new subsidiary in Tokyo to meet growing market demand for the company's digital pathology solutions.

The expansion is being led by Reiko Nishiguchi, sales director, to provide sales, technology, service and marketing support throughout Asia via a dedicated multi-lingual staff.

The company said the new office strengthens its operations in Asia, where it has been working regionally through a distributor. "Japan has emerged as an important stronghold for the company in the past two years, as evidenced by numerous installations of [our] complete digital pathology solution, which includes the ScanScope digital slide scanning system, Spectrum data management software, and image analysis software."

The majority of customers leveraged grant funding provided by Japan's Ministry of Health, Labor, and Welfare to help overcome the country's pathology-specific challenges.

"[Our] momentum . . . continues to build worldwide, as organizations turn to us for assistance in ensuring timely, global, and secure access to pathology data without the encumbrance of glass slides," said CEO Dirk Soenksen. Because digital pathology data can be accessed via computer, pathologists now have a vastly simpler way to share slides internationally."

Aperio also has several installations throughout Singapore, Taiwan, Korea and Thailand – markets it said are "well poised for further growth."

The company currently has an installed base of more than 500 systems in 32 countries.

Canada clears QuadraLase

Candela (Wayland, Massachusetts) said Health Canada has cleared the new QuadraLase advanced CO₂ fractional laser for distribution in Canada. Launched at the American Academy of Dermatology annual meeting in March, the QuadraLase is changing the way practitioners are looking at fractional CO₂ laser treatments. With a unique combination of the proven performance of a CO₂ laser and an innovative scanning device, the QuadraLase is an effective solution for popular aesthetic treatments such as skin rejuvenation, skin tightening/wrinkle reduction, uneven tone and texture, and acne scarring.

President/CEO Gerard Puorro said, "Candela's customers in the U.S., Europe and Australia are looking at fractional CO₂ in a new way and embracing the QuadraLase as a total rejuvenation system. In addition, they are reporting that the QuadraLase is a great option for patients who want fast results and better looking skin without the need for multiple treatments."

Puorro added, "We are excited that the expansion of the QuadraLase into Canada means that practitioners will have more choices and greater flexibility to meet their individual practice needs. Numerous physicians that have used other fractional technologies have reported that they are very satisfied with the results that they are getting with the QuadraLase without the cost of consumables."

Puorro continued, "Additionally, our customers in other parts of the world are finding that the QuadraLase is the ideal complement to our lasers including the AlexTriVantage, our multi-wavelength Q-switched laser, and the Vbeam Perfecta for best-in-class, anti-aging treatments."

Brachy seeds okayed in Canada

IsoRay (Richland, Washington) said Health Canada's Therapeutic Products Directorate has approved Proxcelan Cs-131 brachytherapy seeds for sale throughout that country.

IsoRay submitted all the required documentation to Health Canada earlier this year and received notification on April 24 that approval of its Class 3 Medical Device License Applications for Model CS-1 Proxcelan (Cesium-131) Brachytherapy Seeds and the Proxcelan Sterile Implant Devices containing Model CS-1 Seeds had been granted.

"This completes another step in being able to expand the potential distribution of cesium-131 brachytherapy seeds," said CEO Dwight Babcock. "We initially plan to leverage the relationships of our exclusive U.S. distributor, BrachySciences, and contacts we have made with Canadian physicians who are interested in using cesium-131 to treat their patients. Through these channels we hope to begin to penetrate the Canadian brachytherapy market."