A Medical Device Daily

Sorin Group (Milan, Italy) reported the Japanese approval and the market release of Isoline, its latest generation of defibrillation leads.

Isoline defibrillation leads have a multi-lumen structure with a silicone body and include an ETFE protective coating placed around the cables leading to the electrodes. This redundant insulation also is covered by a third layer of protection consisting of a polyurethane overlay to provide better abrasion resistance.

Sorin said Isoline leads are steroid-eluting, dual-coil defibrillation leads available in two fixation models and two lengths. The leads include EasyTurn, a quick lead placement system for positioning the lead and extending the helix with a single stylet, and Easy Mapping to obtain pacing thresholds without helix extension.

Isoline leads and other Sorin cardiac rhythm management devices are distributed in Japan by Japan Lifeline (JLL; Tokyo), with which Sorin signed a 10-year partnership agreement last year.

"The approval of Isoline ensures JLL can now distribute a complete Sorin Group ICD system, composed of the Ovatio ICD family and Isoline defibrillation leads," said Fred Hrkac, president of Sorin Group's CRM Business Unit.

The Isoline approval in Japan came two months after the FDA's approval of the leads in the U.S. The leads were launched in Europe two years ago.

Invisalign system okayed in Japan

In other Japanese device news, Align Technology (Santa Clara, California) said it has received regulatory approval from the Ministry of Health, Labor and Welfare for its Invisalign teeth-straightening system.

The company said it has trained roughly 660 Invisalign orthodontists since launching the product in Japan in October 2005, and may now begin widespread marketing and promotion of Invisalign in that country.

"This regulatory approval in Japan is an important milestone and will enable us to engage in more traditional and expansive outreach activities to educate and support dental professionals with the necessary marketing activities needed to build the market for Invisalign in Japan," said Gil Laks, vice president of the company's international unit. "We can now leverage the strength of the Invisalign brand by targeting prospective patients in Japan with consumer demand creation programs."

Quest's India unit gets accreditation

Quest Diagnostics (Madison, New Jersey) said its wholly-owned subsidiary, Quest Diagnostics India (Gurgaon, India), has received certificates of accreditation from the College of American Pathologists (CAP), a leading international laboratory accrediting organization, and the National Accreditation Board for Testing and Calibration Laboratories (NABL), the sole government-authorized laboratory accreditation body in India, for its diagnostic and clinical trials laboratory in Gurgaon.

In addition, the National Glycohemoglobin Standardization Program has awarded Level I Laboratory Certification to the laboratory. Level I Laboratory Certification, which is recommended by NGSP for laboratories conducting diabetes-related clinical trials, indicates that a facility's testing fulfills rigorous standards for delivering accurate hemoglobin A1c (HbA1c) testing for diabetes.

The Quest Diagnostics lab is one of only five laboratories in India to be certified by the program. The company said the prevalence of Type 2 diabetes in India is expected to grow more rapidly than in any developed or developing nation, growing from 28 million patients in 2007 to more than 60 million by 2017.

Distribution agreement for Luminex

Luminex (Austin, Texas) and Mingyuan Medicare Development (Hong Kong), a supplier of biomedical products in China, reported the signing of a distribution and supply agreement under which Mingyuan will serve as the exclusive distributor in China and Hong Kong of a series of newborn screening products being developed for the diagnosis of genetic disorders.

"Accurate and efficient newborn screening is essential to good pediatric care," said Chien Hoe Yong Henry, CEO/executive director of Mingyuan. "With Luminex's xMAP Technology, we can quickly and precisely screen infants for many genetic disorders at once. The technology and new tests being developed will help us advance the accuracy and speed of newborn screening across China and Hong Kong."

More than 20 million babies are born in China each year, and newborn screening of genetic disorders is mandated by the Chinese government.

The newborn screening tests to be distributed by Mingyuan will be developed by Luminex utilizing its xMAP Technology. Rather than detecting each genetic disorder one at a time, xMAP Technology can simultaneously analyze up to 100 unique assays within a single sample, making the large-scale screening more efficient, accurate and less costly.

Mingyuan also will distribute Luminex analyzers in China and Hong Kong.

Plan of arrangement for Med-Emerg

Med-Emerg International (Toronto) said it has obtained an interim order from the Ontario Superior Court of Justice concerning its previously announced plan of arrangement pursuant to which AIM Health Group (Markham, Ontario) will acquire all of MedEmerg's outstanding shares.

Under the arrangement, holders of MedEmerg common shares will receive 0.78091 of an AIM common share for each MedEmerg common share, subject to adjustment in the case of fractional AIM common shares.

A special meeting of shareholders, called to approve the arrangement, will be held on Jan. 8. Shareholders of record as of Nov. 24 will be entitled to vote at the special meeting.

The board of directors of MedEmerg has recommended that MedEmerg shareholders vote in favor of the arrangement.

MedEmerg specializes in the coordination and delivery of healthcare services in Canada. Those services include an integrated chronic pain management program, community-based infusion centers and health human resource management, including physician and nurse staffing.