A Medical Device Daily
Smith & Nephew Orthopaedic Reconstruction (Memphis, Tennessee) of Smith & Nephew (S&N; London) reported Japanese regulatory approval of its Oxinium oxidized zirconium technology.
Oxinium is a proprietary transformed metal alloy with a ceramic-bearing surface. The material provides low friction and wear resistance combined with the strength of a metal implant, S&N said.
The company said that it is the only orthopedic company to offer such a joint replacement material. It said Oxinium is the only orthopedic implant material to receive the ASM International Engineering Materials Award for outstanding achievement of a material used in the design and manufacture of products.
This approval marks the first time the Oxinium technology will be available in the world’s second largest orthopedic market. The company’s Genesis II knee system, which has been used in more than 500,000 surgeries worldwide and has 10-year clinical data showing 98% survivorship, will be the first implant system available in Japan with Oxinium.
“This is an important milestone for Smith & Nephew and our Oxinium platform,” said Joseph DeVivo, president of S&N Orthopaedic Reconstruction. “Our premier technology is revolutionizing joint replacement around the world by providing and maintaining unparalleled wear resistance.”
He said the Oxinium material “has proven to be a superior metal in implants, and our ... technology has given patients the significant benefit of greater durability from their implants. Japanese physicians and patients ... have been anxiously awaiting this approval.”
Oxinium was developed and patented by individuals within S&N Orthopaedic’s research, development and manufacturing groups. All of the company’s major knee and hip implant systems — including the Genesis II, Legion, Journey BCS and Journey Deuce knee systems, and Synergy and Anthology hip systems, are available with Oxinium oxidized zirconium technology.
The first Oxinium oxidized zirconium component was implanted in 1995 and more than 230,000 hip and knee components have since been implanted.
New facility for Spacelabs in China
Spacelabs Healthcare (Issaquah, Washington), a division of OSI Systems (Hawthorne, California), reported the official opening of its new manufacturing facility in Suzhou, China.
The roughly 55,000-square-foot manufacturing facility, located about 50 miles east of Shanghai, initially will be focused on developing and manufacturing healthcare products for emerging markets. OSI said the facility also will serve as the cornerstone for the company’s emerging market activities, providing R&D, aftermarket service, training, marketing and sales support while also operating within its global supply chain.
Deepak Chopra, CEO of OSI, said, “This manufacturing facility complements our global manufacturing strategy and underscores our commitment to the emerging markets. By expanding our presence in the Asia Pacific region we are able to provide our range of products at competitive prices improving our competitiveness globally.
“The facility will play an integral role in our global supply chain expanding our range of suppliers and lowering our component costs for our entire product range. As a result we expect that the new facility will have a positive impact on our gross margins as we move into the next fiscal year.”
Spacelabs is a global provider of medical equipment and services, including solutions for patient monitoring and connectivity, anesthesia delivery and ventilation, diagnostic cardiology and supplies and accessories selling to hospitals, clinics and physician offices. The company also provides centralized cardiac safety and diagnostic services to biopharmaceutical companies undertaking clinical trials.
The company has offices in the U.S., UK, Canada, France, Germany, Finland, India, China and Singapore.
Quintiles lab in India CAP-certified
Quintiles Transnational (Research Triangle Park, North Carolina) said that its central laboratory in Mumbai, India, has been certified by the College of American Pathologists (CAP). The lab began supporting clinical trials in 1Q07 and “has seen steady growth and has been adding services and analytical capabilities to a growing test menu,” Quintiles said.
“CAP certification validates our commitment to providing high-quality central laboratory services that fulfill rigorous regulatory requirements worldwide,” said Tom Wollman, senior VP, Quintiles Global Central Laboratories. “With the certification of the India laboratory, Quintiles Central Laboratory Services now has the largest wholly owned CAP-accredited laboratory network in the world.”
He added, “This tightly controlled network with CAP-certified laboratories in the U.S., Europe, South Africa, China, India and Singapore allows us to support global and regional trials in almost every country in the world.”
The Mumbai lab provides project management and logistical support, study specific laboratory kits for sites, local investigator support and samples management, storage and processing using consistent global methods.
Scottish hospital project to Skanska
Skanska (Stockholm, Sweden) has won a contract to construct the State Hospital in Carstairs, Scotland. The contract amount is £65 million (about SEK 820 million), included in order bookings for 1Q08. The customer is the National Health Service Trust, Scotland’s national healthcare authority.
The project comprises construction of a 19,000-square-meter hospital building and the rebuilding of about 1,500 square meters of existing hospital facilities. Skanska also will undertake the mechanical and electrical installations as well as the voice and data communications systems.
State Hospital is a psychiatric clinic that will house departments for psychiatric and somatic healthcare, as well as facilities for therapeutic, vocational and physical activities on the site.
Skanska is currently building six hospitals in Great Britain. The two largest building projects are now under way in London – the Barts and London hospitals - being constructed within the Private Finance Initiative program for public-private partnerships.