Japanese Regulators OK Zoll Medical Marketing Plan for Monitor/Defibrillator

Asahi Kasei Zoll Medical (AZM), the Japanese subsidiary of Zoll Medical Corporation, has received Shonin approval from the Japanese Ministry of Health, Labour and Welfare to commercialize its R Series Monitor/Defibrillator.

AZM, established two years ago to pursue the regulatory approval, sale, and marketing of ZOLL products in Japan, will begin marketing and selling the R Series in early 2015. The R Series in U.S. hospitals goes beyond defibrillation and incorporates a complete suite of tools to assist with the delivery of high-quality CPR, now recognized as the single most important factor driving survival from cardiac arrest, the company claims.

The R Series Code-Ready units are designed to assist personnel in delivering “simple, smart, and ready” resuscitation to every hospital department. The R Series offers rescuers a CPR Dashboard to monitor depth, rate, release, and perfusion as well as audible prompts for depth and rate. In addition a See-Thru CPR filter removes CPR artifact and enables rescuers to see the underlying rhythm, reducing the duration of pauses, Zoll bigwigs note.

“We are very excited to introduce the market-leading R Series to Japan and to continue to offer technologies and devices for acute critical care to this major market,” said Jonathan A. Rennert, Zoll president. “Since defibrillators are widely distributed throughout hospitals, and their use is both infrequent and extremely critical, code readiness helps clinicians save more lives. By granting Shonin approval, the Japanese Ministry of Health, Labour and Welfare now makes the R Series available to clinicians throughout Japan.”

Zoll Medical Corporation, an Asahi Kasei Group company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and monitoring, circulation and CPR feedback, data management, fluid resuscitation, and therapeutic temperature management, Zoll provides technologies that help clinicians, EMS and fire professionals, and lay rescuers treat victims needing resuscitation and acute critical care.

The Asahi Kasei Group is a diversified group of companies led by holding company Asahi Kasei Corp., with operations in the chemicals and fibers, homes and construction materials, electronics, and health care business sectors. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals, diagnostic reagents, and nutritional products. With more than 29,000 employees around the world, the Asahi Kasei Group serves customers in more than 100 countries.