CAESAREA, Israel--(BUSINESS WIRE)--Based upon adherence to the strictest international standards of quality and clinical trials proving the EndoPAT’s safety and efficacy, the Japanese government has granted SHONIN (“clearance”) to Itamar-Medical’s EndoPAT, paving the way to widespread use in Japan for diagnosing endothelial dysfunction, a key cause of cardiovascular disease.
Japan’s rigorous process by its Pharmaceuticals and Medical Device Agency (PMDA) is considered by many to be even tougher than the American FDA (which is often a prerequisite by PMDA). SHONIN by PMDA allows for direct importation and marketing in Japan, but is also necessary to get coverage by Japan’s National Health Insurance Plan.
“We are extremely pleased to receive the SHONIN approval from PMDA. We truly believe that this official approval by our government may be the start of a very bright future for the EndoPAT in Japan,” said Mr. Yasunori Noto, President of CCI Corporation, an Itamar-Medical distributor in Japan.
“The world is now beginning to discover the revolutionary insight offered by EndoPAT as part of the process in early detection and prevention of cardiovascular heart disease,” said Dr. Dov Rubin, Itamar’s President & CEO.
Endothelial dysfunction is the earliest detectable stage of cardiovascular disease. It precedes clinical symptoms by years, even decades. Multiple studies have demonstrated its key role in the development of atherosclerosis which leads to heart attacks, strokes and other fatal or debilitating diseases. Amazingly, it is highly responsive to treatment, and patients who improve their endothelial function have been shown to suffer a lower rate of cardiovascular events.
Hundreds of EndoPAT systems have been sold in over 40 countries. EndoPAT is used by prestigious medical centers such as Mayo Clinic, leading studies with thousands of participants such as Framingham Heart Study, and in many trials by pharmaceutical companies searching for new ways to treat and prevent heart disease as well as detecting adverse affects before they occur.
About Itamar Medical
Itamar Medical Ltd. is a publicly-traded medical technology company (TASE:ITMR) utilizing PAT™ (Peripheral Arterial Tone) signal technology and applications. The PAT signal is a non-invasive "window" to both the cardiovascular and autonomic nervous systems. For more information, visit www.itamar-medical.com.
Triwaks Public RelationsDaphna Triwaks, firstname.lastname@example.org