A Medical Device Daily

In conjunction with the Japan Heart Rhythm Society annual meeting in Tokyo, Medtronic (Minneapolis) on Friday reported Ministry of Health, Labor and Welfare (MHLW) approval of the Medtronic InSync III Marquis cardiac resynchronization therapy-defibrillator (CRT-D) in Japan.

In addition, MHLW has granted reimbursement approvals for CRT-D devices as a result of Medtronic's work with the Japanese regulatory body.

The InSync III Marquis system combines cardiac resynchronization and defibrillation therapies in a single device for the treatment of moderate-to-severe heart failure in patients who are at risk for sudden cardiac arrest.

The device will be available for sale in Japan at the beginning of next month.

Marshall Stanton, MD, vice president and general manager of the Cardiac Rhythm Disease Management business for Medtronic in Japan, said the MHLW approval of the CRT-D device continues the company's 30-year tradition of leadership in bringing new medical technologies to market in that country.

“Beginning with the introduction and reimbursement of ICDs in Japan in 1996 to cardiac resynchronization therapy-pacemakers in 2004, and now CRT-D, we continue to innovate to bring forward novel therapies and technologies for managing heart failure and heart rhythm disorders, benefiting physicians and their patients,” Stanton said.

About the size of a small stopwatch, the InSync III Marquis device offers sequential bi-ventricular pacing for more precise pacing of the two lower chambers of the heart – and a comprehensive heart failure management report to assist physicians in overall management of heart failure symptoms.

The system includes the advanced therapies of the Marquis DR implantable cardioverter defibrillator, which the company said is the most popular ICD in Japan. The ICD rapidly detects and terminates fast ventricular heart rates that could lead to sudden cardiac arrest, which takes the lives of about 80,000 people in Japan annually.

The InSync III Marquis system also includes Medtronic's Patient Alert feature, which notifies patients with a series of tones when follow-up care is needed.

Cardiac resynchronization therapy is designed to coordinate the contraction of the heart's two lower chambers and improve the heart's efficiency to increase blood flow to the body. More than 1.5 million Japanese suffer from heart failure, which Medtronic said is the only major cardiac condition that continues to grow in prevalence.

The FDA approved the original InSync system in August 2001. The InSync III Marquis CRT-D device has previously been approved for use in numerous countries around the world, including the U.S. and Europe.

CombiMatrix in accord with Macrogen

Acacia Research (Newport Beach, California) said that its CombiMatrix (Mukilteo, Washington) group has entered into a manufacturing and distribution agreement with Macrogen (Seoul, South Korea). The agreement establishes Macrogen as a key distributor and enables that firm, through use of CustomArray Synthesizers that it has purchased, to synthesize content onto CustomArrays for distribution in South Korea and to offer CustomArray-based services.

Macrogen, which Acacia termed “Korea's leading bio-technology company,” started out as a lab venture company in Seoul National University in 1997.

CombiMatrix's strategy for the R&D market is to establish manufacturing and distribution relationships with regional companies to enable them to manufacture arrays onsite for their local markets.

“Macrogen has been partnering with the world's leading biotechnology companies and organizations to become the powerhouse of revolutionizing research in Asia,” said Byung-Hwa Lee, that company's CEO. “In Korea, we have been very fortunate to lead this effort by utilizing our core technologies in sequencing, microarrays, especially in array CGH, and mouse models to study human diseases.”

He said the CombiMatrix technology “is the most exciting microarray technology yet to be commercialized in the world,” citing its “flexible and easy-to-use platform that allows a rapid adaptation of new biological contents to be diagnosed within days instead of months.”

“This kind of plasticity was missing until now in all other microarray technologies, and working with Combi-Matrix will enable Macrogen to better position itself as a leader in the diagnostic microarray market,” said Dr. Jason Kang, Macrogen's chief technology officer.

Dr. Amit Kumar, president and CEO of CombiMatrix, cited Macrogen's “great expertise” in a wide variety of areas, including arrays, array services and bioinformatics. “We and Macrogen view the growing role of microarrays in the world – in R&D, infectious-disease monitoring and tracking, and diagnostics – as one of enormous opportunity.”

Macrogen's core businesses include DNA sequence analysis, manufacture of biochips, and production of genetically engineered mice. It is recognized for its genomic information analysis technology and as a global service provider of sequencing services and expression profiling.

Acacia Research comprises two operating groups, Acacia Technologies group and CombiMatrix group.

Cylex signs Japanese distributor

Cylex (Columbia, Maryland), a life sciences company focused on immune function testing, reported a supply agreement with Medical & Biological Laboratories Co. Ltd. (MBL) to distribute Cylex's ImmuKnow assay in the Japanese market.

Distribution of the assay throughout Japan will begin immediately.

Cylex's flagship product, ImmuKnow, is the first and only FDA-cleared cellular assay for measuring and managing the health of a patient's immune system. The company said it has “significantly expanded” its customer base in the international market and that this agreement marks ImmuKnow's official entry in the Asian market.

“MBL [is] a leader in the autoimmune, immunology and infectious disease diagnostic markets in Japan,” said Tim Ellis, president of Cylex. “ImmuKnow's breakthrough into the Asian market further confirms the acceptance of the assay, not only in the U.S., but on a global level, as well.”

The assay is currently used in the management of transplant recipients at more than 50 U.S. medical centers. ImmuKnow also is being utilized in widespread research applications.

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