A Medical Device Daily

A group of U.S.-based med-tech companies has launched the American Medical Devices and Diagnostics Manufacturers' Association (AMDD; Tokyo), representing the Japanese operations of more than 60 U.S. firms.

AMDD was established as of April 1 as an independent organization to foster speed and efficiency when addressing the common advocacy interests of companies formerly represented by the Medical Devices and Diagnostics Subcommittee of the American Chamber of Commerce in Japan (ACCJ).

Advocacy activities include providing policy recommendations related to regulatory issues, national health insurance reimbursement payments, and healthcare system reform in Japan, in order to provide global-standard advanced medical technology to Japanese patients.

"The AMDD will conduct activities to establish an environment where the value of advanced medical technology is fully appreciated, with the aim of improving patient quality of life, saving lives and reducing medical expenditure," said Dr. Huimin Wang, chairman of AMDD and corporate vice president, Japan and Intercontinental, for Edwards Lifesciences (Irvine, California).

"This will be achieved through the adoption of advanced medical technology; that is, minimally or non-invasive diagnostics and treatment," Wang said.

David Powell, vice chairman of AMDD and president, Johnson & Johnson KK, said, "The AMDD will work with Japanese and European industry associations when submitting recommendations to the government to address the delay of approval of advanced medical technology, also known as the device lag, and innovative product pricing."

The association said it will "undertake activities to provide Japanese patients with greater access to advanced medical technology, utilizing global best practices, maintaining a close collaborative relationship with the U.S. government and the U.S.-based industry association, Advanced Medical Technology Association (AdvaMed; Washington), and collaborating with the Japanese government, academic societies and other industry organizations."

The AMDD's 62 member companies account for roughly 13,000 jobs in Japan and generate some $8.5 billion in sales, representing 40% of the Japanese medical technology market.

ATS heart valve approved in Japan

ATS Medical (Minneapolis) reported that the Ministry of Health, Labor and Welfare has approved commercial distribution of the ATS Open Pivot AP360 mechanical heart valve in that country.

ATS said the AP360 heart valve "maximizes hemodynamic performance with a new supra-annular cuff design that facilitates implantation."

The company said the original ATS Medical Open Pivot Heart Valve is "highly regarded for fundamental design features that promote best-in-class hemodynamic performance, enhanced resistance to blood clot formation and improved patient quality of life through quieter valve operation."

It said the ATS AP360 is a response to the "highly individualized and specific valve selection criteria of cardiac surgeons, particularly with respect to implantability," and combines "proven performance with a cuff design that extends its appeal to a broader spectrum of surgeons."

"Our longtime distribution partner, Century Medical, worked diligently to facilitate this important approval in conjunction with the ATS quality and regulatory organization," said Michael Dale, president/CEO of ATS Medical. "The cuff design of the ATS AP360 valve provides significant hemodynamic benefit for patients with a small aortic root and will be ideal for the unique needs of the Japanese market."

ATS Medical focuses on two distinct but "operationally synergistic" market segments of the cardiac surgery sector: heart valve disease therapy and surgical ablation of cardiac arrhythmias.

1st RapidArc treatments in India

Clinicians at Yashoda Cancer Institute (Hyderabad, India) have carried out that country's first treatment using a new, faster form of radiotherapy that extends more advanced care to more patients. A 72-year-old bladder cancer patient received the treatment using RapidArc radiotherapy technology from Varian Medical Systems (Palo Alto, California).

Varian said the RapidArc technology makes it possible to deliver image-guided IMRT (intensity modulated radiotherapy) two to eight times faster than is possible with conventional IMRT.

Srinivas Chilikuri, MD, said RapidArc delivers a precise and efficient treatment in single or multiple arcs of the treatment machine around the patient and offers several advantages over traditional approaches.

"The whole treatment duration including set-up and check was completed in 10 minutes, which involved just 90 seconds of beam-on' time. We witnessed high dose conformity, excellent target coverage and good critical tissue sparing, but the main advantage was the speed of the treatment."

Chilikuri said speed is particularly important because of the large number of cancer patients in India. "In a country like ours with a heavy cancer burden, there is a real issue with waiting lists," he said. "We deal with this by prioritizing and optimizing treatment facilities and RapidArc is an excellent example of this approach. With this, we can carry out faster and more precise treatments with less complex delivery and less complicated quality assurance requirements."

He said the clinical team at Yashoda plans to use RapidArc for a variety of common cancers such as head and neck, cervical, prostate and lung, as well as complicated tumors that are otherwise difficult to treat with other techniques.

Yashoda Cancer Institute is a 200-bed comprehensive cancer research and treatment center operated by Yashoda Hospitals. The institute provides care to 7,000 cancer patients every year.

Japan distributor deal for Sorin

Sorin Group (Milan, Italy) said it has entered into a long-term exclusive distribution agreement with Japan Lifeline Co. Ltd. (JLL). Under the 10-year agreement, JLL becomes the exclusive distributor in Japan for the entire portfolio of Sorin's Heart Valves Business Unit, including mechanical heart valves and annuloplasty rings.

In addition, JLL will distribute Sorin's Mitroflow tissue heart valve and the sutureless Perceval heart valve upon receipt of regulatory approvals.

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