Occlutech has obtained approval from the Japanese Ministry of Health, Labour and Welfare for its atrial septal defect closure device. This product is indicated for the minimally invasive closure of atrial septal defects (ASD).
The approval has been made possible by a partnership between Occlutech and Japan Lifeline, who released the first ASD occlude in Japan in 2005.
Tor Peters, chief executive officer of the Occlutech Group comments, “Our partnership with Japan Lifeline has been very productive and we are proud to be associated with this company and its dedicated employees.”
Keisuke Suzuki, president and chief executive officer of Japan Lifeline, states, “In 2005 we pioneered the introduction of the first ASD occluder in Japan, and we have been contributing to the spread of ASD occluders as patient-friendly and minimally invasive medical devices. Although we suspended sales of ASD occluders in 2011 due to Distribution Agreement expiration, we are re-entering the structural heart disease treatment market by introducing Occlutech’s excellent products.
According to a press release, Occlutech’s ASD occluder consists of a flexible nitinol wire mesh with “shape-memory” properties. Occlutech’s proprietary technology is designed to allow for the creation of products with unique properties regarding flexibility and adaptability. The implant will be available in different configurations and sizes to accommodate a broad range of defects. The Occlutech ASD implant is intended to allow fast, atraumatic, minimally invasive closure of these defects.