A Medical Device Daily

Kinetic Concepts (San Antonio) has received reimbursement approval from Japan's Health Insurance Bureau for use of the V.A.C. ATS Therapy System in the country. The approval signifies an important advancement in the company's plans for market launch in April and follows Japan's Ministry of Health, Labor and Welfare's decision in November 2009 to grant final regulatory approval for the product.

The decision provides reimbursement coverage to physicians and hospitals for using the V.A.C. ATS Therapy System on patients suffering from severe wounds. V.A.C. Therapy, a product of KCI's Active Healing Solutions division, promotes wound healing through negative pressure wound therapy. V.A.C. Therapy has treated more than three million patients worldwide and has been clinically proven in more than 20 randomized controlled trials and nearly 500 peer-reviewed journals.

“Japan represents a very important and underserved market for advanced wound care,“ said Catherine Burzik, KCI's president/CEO. “This reimbursement decision serves as a significant milestone as we plan for market launch and first patient placements in early April. We are pleased that the Japanese government has recognized the clinical value of our V.A.C. Therapy for patients, and the people of KCI are committed to helping physicians and nurses improve the lives of wound care patients in Japan.“

Mike Genau, KCI's global president, Active Healing Solutions, said: “We see tremendous opportunity to serve patients across the Asia Pacific region, and we're proud to bring our V.A.C. Therapy to help patients in Japan heal faster. Our clinical trial in Japan clearly demonstrated the benefit V.A.C. Therapy will bring to patients and the Japanese healthcare system.

SFDA approves Sunridge's glaucoma treatment

Sunridge International (Fountain Hills, Arizona) said that China's State Food and Drug Administration, (SFDA), had approved the firm's pneumatic trabeculoplasty (PNT) treatment in China.

Sunridge CEO, G. Richard Smith, said that the SFDA approval marked a major step forward for the company which would, hopefully, bring with it added relief to the glaucoma sufferers in China.

“Our exclusive distributors, Beijing Vision World Trading Co, have informed us that they have received all necessary government documentation approving PNT as a medical treatment for glaucoma and ocular hypertension, as well as marketing approval for our equipment and disposable line of products,“ Smith said.

“The SFDA approval has been hard won. It marks the culmination of 3.5 years of consistent market development that has included multiple clinical trials in both private and state run military hospitals. It has come through the effort of a number of dedicated people and it was worth every moment,“ said Waisheng Yang, president of Beijing Vision (Beijing). “We are now ready to start our marketing operations throughout China and to reach out to its 10 million or more glaucoma patients.“

Smith added that the next phase of the company's marketing program in China had already begun. “Along with the good news of the approval, came an initial order for 30 units and 10,000 rings. This order will allow Beijing Vision to place units in hospitals throughout China, and with sub distributors in a number of provinces.“

PNT is a two-minute non-invasive alternative for treatment for glaucoma and ocular hypertension.

Irrigated tip catheter market to grow by 15%

According to Millennium Research Group (MRG; Waltham, Massachusetts), the recent launch of irrigated-tip catheters into the Japanese market will drive the ablation catheter market by a compound annual growth rate of approximately 15% through 2014.

Irrigated-tip radio frequency (RF) ablation catheters offer a significant improvement over conventional models because they minimize damage to surrounding tissue, and thus are useful in more complex arrhythmia treatments, such as those performed for atrial fibrillation or ventricular tachycardia.

In mid-2009, Biosense Webster (Diamond Bar, California) launched the Japanese market's first irrigated-tip catheter, the Navistar Thermocool. The anticipated 2010 launch of St. Jude Medical's (St. Paul, Minnesota) new irrigated-tip catheter, Therapy Cool Path, will further expand accessibility of this device type in Japan. MRG's new Japanese Markets for Electrophysiology Mapping and Ablation Devices 2010 report finds that the recent and upcoming launches will fuel growth in irrigated-tip RF ablation catheter procedures, expanding the overall volume of RF ablation procedures to nearly 60,000 by 2014.

“Japanese physicians have had to wait much longer than their U.S. and European counterparts for irrigated-tip catheters to become available,“ said Julie McLaughlin, analyst at MRG. “Because the increased safety profile makes these devices the preferred ablation catheter for atrial fibrillation, adoption by Japanese physicians will be high as they look to expand their treatable patient population by taking on more complex cases.“

EDAP gets Japanese approval for Sonolith I-Sys

EDAP (Lyon, France) said the Japanese Administration has granted marketing approval of its Sonolith I-Sys lithotripsy device. The lithotripsy market in Japan ranks number one worldwide in both total lithotripsy sales volume and installed base, the company said. With integrated and robotized features, Sonolith I-Sys fully addresses the Japanese lithotripsy market demands for new high-end technologies.

Marc Oczachowski, EDAP's CEO, said, “Japan is the largest global lithotripsy market and the latest key territory we have received approval for Sonolith I-Sys. According to the company, this approval is a major milestone and further validates EDAP's position as a major worldwide player in the lithotripsy field, with Sonolith I-Sys approved in all lithotripsy markets in the world. We are very enthusiastic with the Japanese approval of our Sonolith I-sys lithotripter. We are convinced that our innovative, high-end device perfectly suits the Japanese lithotripsy market and will allow us to successfully address the strong demand of major clinical centers and university hospitals.“

The device was approved by the FDA in August 2009 and the Japanese Administration in March 2010.