AMedical Device Daily

Syneron Medical (Yokneam, Israel) and its Chinese distributor, Miracle Laser (Wuhan, China), reported that China’s State Food and Drug Administration (SFDA) has granted regulatory approval for the sale of Syneron’s products in that country.

Noting that the Chinese regulatory environment “has matured in recent years to match the expectations of the Chinese consumer,” Thomas Goslau, Syneron’s director of marketing & sales for Asia-Pacific, said the SFDA approval “firmly endorses and validates our products in the eyes of our customers, who must still deal with the numerous low-cost and non-approved foreign products that have flooded the Chinese market.”

Syneron and Miracle Laser recently signed a strategic partnership agreement to develop the Chinese market for the Israeli firm’s elos (Electro-Optical Synergy) product platforms. Vivian Peng, CEO of Miracle Laser, said, “Syneron’s strong record of efficacy and safety in Asia, backed by SFDA approval, will support and energize our aggressive and combined effort to rapidly penetrate the market.”

Shimon Eckhouse, Syneron chairman and inventor of the company’s elos and IPL light technologies for aesthetic medicine, called Miracle Laser “the most powerful company in China” for the distribution of such products.

Syneron said its elos technology “combines optical energy and electrical energy (bi-polar radio frequency) to enable a wide range of efficient, safe and cost-effective medical aesthetic treatments on all skin types.” Its systems provide advanced solutions for a broad range of medical-aesthetic applications, including hair removal, wrinkle reduction, rejuvenating the skin’s appearance through the treatment of superficial benign vascular and pigmented lesions, and the treatment of acne, leg veins and cellulite.

Miracle Laser manufactures and distributes light-based medical and aesthetic devices, with an installed base in China of more than 6,000 units.

Pronto catheter OK for sale in Japan

Also receiving product approval in Asia was Vascular Solutions (Minneapolis), which said its Japanese distribution partner, Nihon Kohden (Tokyo), reported the completion of import license and reimbursement notification for the sale of the firm’s Pronto catheter in that country. Sales of the device to Nihon Kohden for distribution in Japan have begun.

The Pronto catheter is designed for the mechanical aspiration removal of acute thrombus from the arterial system.

Howard Root, Vascular Solutions’ CEO, said, “After the U.S., we believe that Japan is the second-largest market for thrombus aspiration catheters.” He said completion of the Japanese registration process was accomplished one quarter ahead of schedule, saluting Nihon Kohden for its focus on the process.

Masami Sugiyama, corporate director and general manager of import business operations for Nihon Kohden, said his company’s collaboration with Vascular Solutions will allow it to extend its presence in the soft thrombus removal market in Japan. “We believe the combination of Nihon Kohden’s nationwide sales network and Vascular Solutions’ Pronto extraction catheter will prove to be mutually beneficial for both organizations.”

Uganda institute backs Calypte tests

Calypte Biomedical (Pleasanton, California) said that the HIV/AIDS Reference and Quality Assurance Laboratory at the Uganda Virus Research Institute (Entebbe, Uganda) has issued a recommendation that the Uganda National Drug Authority grant approval for the importation of the Calypte rapid HIV 1/2 Antibody Tests using blood, oral fluid and urine as a specimen.

The company said the recommendation would allow it to begin importation of the suite of rapid HIV diagnostics into the Republic of Uganda.

The Calypte assays were assessed during a prospective study that evaluated about 350 subjects and were performed at the Uganda Virus Research Institute. The Calypte Aware (BSP), Aware (U) and Aware (OMT) each were deemed satisfactory for assay accuracy and operational qualities as compared with a standard HIV 1/2 test algorithm.

The evaluation report added: “There is yet to be another rapid urine test with performance similar or superior to the Aware (U) from Calypte Biomedical.”

Dr. J. Richard George, president and CEO of Calypte, said, “This is the first regulatory approval that we have received for our rapid HIV testing platform and believe that it will be the first of many. We . . . are currently in the process of finalizing an agreement with our distributor in this territory.”

As of the end of 2003, it was estimated that about 530,000 adults and children in Uganda were living with HIV/AIDS.

New Greatbatch facility in Mexico

Greatbatch (formerly Wilson Greatbatch Technologies; Clarence, New York) has opened a new 144,000-square-foot manufacturing facility in Tijuana, Mexico. The facility initially will provide sub-assembly operations for the company’s cardiac rhythm management customers.

“With the opening of the new facility, the company is adding important assembly operations to its already broad-based product offering for [a] critically demanding marketplace,” said Mauricio Arellano, vice president of Greatbatch Mexico. “This new facility is designed with state-of-the-art manufacturing and cleanroom capability to meet the high standards of the medical device industry.”

Mexican President Vicente Fox and other local and regional officials were guests at the grand-opening ceremonies for the new plant.

Wilson Greatbatch is a manufacturer of critical components used in implantable medical devices and other applications.