A Medical Device Daily

Boston Scientific (Natick, Massachusetts) reported regulatory approval and market launch in Japan for its Vitality DR implantable cardioverter defibrillator (ICD) system, which it said is the smallest dual-chamber ICD currently offered in Japan.

Boston Scientific said the Vitality DR system is based on the established Vitality line of products and "offers advantages for both patients and physicians." For example, the size and shape of the Vitality DR (30 cc and 11 mm) is designed to facilitate ease of insertion and contribute to patient comfort.

The system incorporates AV Search Hysteresis (AVSH) programming — a feature that reduces right ventricular (RV) pacing when the heart's natural rhythm is present.

"The INTRINSIC RV trial recently showed that dual-chamber ICD programming can provide benefits to patients such as improved heart function and enhanced arrhythmia detection," said Peter Coenen, VP, Japan, for the company.

The company estimates that sudden cardiac death claims the lives of as many as 50,000 people a year in Japan. It says that more than 100,000 ICDs from the Vitality family have been implanted worldwide since the system was introduced in Europe in 2002.

NxStage moves some manufacturing to Mexico

Another Massachusetts-based company, NxStage Medical (Lawrence), manufacturer of the NxStage System One portable kidney dialysis machine, said it will initiate manufacturing of certain of its System One products in Fresnillo, Mexico, as part of its efforts to reduce product costs.

Beginning in May, NxStage will execute a phased relocation of the manufacture of its PureFlow SL disposables and System One cycler to a new facility provided by the Entrada Group in Fresnillo. In the future, NxStage also plans to use the facility to manufacture other System One components, including PureFlow SL hardware.

"This strategic initiative will enable NxStage to control costs and quality as we expand our manufacturing operations to support our growth and successful PureFlow SL roll-out," said president/CEO Jeff Burbank. "After a comprehensive evaluation of alternatives to increase our manufacturing capacity, we concluded that Entrada's facilities in Mexico, with access to a highly-skilled, low-cost workforce, will be a strategic advantage."

The Entrada Group is a Texas-based provider of manufacturing facilities and contract services for companies seeking production capacity in Mexico. The new facility being built by Entrada will be designed to meet FDA Quality System Regulations, NxStage said.

NxStage says that the System One is the first "truly portable hemodialysis system cleared for home use by the FDA." It says that unlike traditional dialysis equipment, System One plugs into standard electrical outlets, requires no special infrastructure to operate and is easy to use by trained patients and their trained partners.

"Rather than commuting to and from a dialysis clinic three times per week for scheduled treatment sessions lasting three to four hours, patients who use the NxStage System One have the freedom to conduct prescribed treatments at home on their own schedule and to bring the system with them when they travel," the company said in a statement.

Tyco buys Brazilian suture maker

Tyco International (Pembroke, Bermuda) said that the Surgical Devices business of its Tyco Healthcare (Mansfield, Massachusetts) unit has acquired Polysuture, a Brazilian suture manufacturer.

Terms of the transaction, which is subject to regulatory approval in Brazil, were not disclosed.

Rich Meelia, CEO of Tyco Healthcare, said, "The healthcare market in Latin America is growing rapidly and our manufacturing presence in the region will enable us to compete more effectively and to serve this market with a comprehensive suture product portfolio."

Located in Sao Sebastiao do Paraiso, Minas Gerais, Brazil, Polysuture was founded six years ago and employs 200. The company makes gut, silk and nylon sutures that may be used in virtually all surgical procedures. These core products, coupled with the specialty suture products now sold by Tyco Surgical Devices under the Syneture brand, will be sold by Polysuture's existing distributor network.

Prototypes set for Bovie forceps

Bovie Medical (Melville, New York) reported that its Canadian subsidiary has completed the prototypes of the company's Polaris line of monopolar and bipolar modular forceps. The patent pending Polaris line offers all the benefits of the company's recently FDA cleared modular ergonomic grip (MEG) forceps line while expanding the cartridge offerings to bipolar endoscopic cartridges (jaws and electrodes), between 4mm-12 mm in diameter. The polaris line will offer monopolar and bipolar energy combined with intelligent feedback from an electrosurgical generator. The polaris handle will also accommodate a wide array of possible applications in either monopolar or bipolar surgeries — serving endoscopic needs in multiple endoscopic fields.

Bovie Medical makes electrosurgical products.

Philippines hospital orders Biofield system

Biofield (Philadelphia) said a hospital in the Philippines has ordered the Biofield Diagnostic Electropotentials System and three cases of sensors, representing enough complete sets for 600 exams. Delivery is scheduled for the end of March.

The Biofield Diagnostic System is a breast cancer diagnostic device employing single-use sensors to measure and analyze changes in cellular electrical charge distributions associated with the development of epithelial cancers, such as breast, ovaries, skin, prostate and colon cancers.

The company's device is intended for palpable breast lesions, in women under 55.

Biofield said it believes there are "great opportunities" for its technology in the Philippines, which has 27 million women ages 15-64.

Japanese okay for Sevoflurane

Minrad International (Orchard Park, New York) said that its exclusive distribution partner in Japan, Merck Seiyaku, has received approval of Sevoflurane from the Japanese Ministry of Health. Prior to sale of Sevoflurane in Japan, Merck Seiyaku will need to receive pricing authorization from the Japanese government, which it expects in July.

Minrad is an interventional pain management company with real-time image guidance and anesthesia and analgesia product lines.