Updated on 13 January 2016
Tokyo: Occlutech, a Germany-based innovator of implants to treat structural heart disease, has obtained Japanese MHW approval for its dedicated Atrial Septal Defect Closure Device. The device is a specifically designed implant indicated for the minimally invasive closure of Atrial Septal Defects (ASD).
Tor Peters, CEO of Occlutech Group, commented, "We are extremely pleased to be able to provide patients and cardiologists in Japan with this innovative product and expect our ASD occluder to significantly add and improve therapy options for this patient population. Our partnership with Japan Lifeline has been very productive and we are proud to be associated with this company and its dedicated employees. A special thanks goes to the opinion leading physicians in Japan who have encouraged and supported this process."
Keisuke Suzuki, President and CEO of Japan Lifeline, also made the following statement, "In 2005 we pioneered the introduction of the first ASD occuluder in Japan, and we have been contributing to the spread of ASD Occuluders as patient-friendly and minimally invasive medical devices. Although we suspended sales of ASD occuluders in 2011 due to Distribution Agreement expiration, we are reentering the structural heart disease treatment market by introducing Occlutech's excellent products."
The company explained that its ASD occluder consists of a flexible nitinol wire mesh with ‘shape-memory' properties. Occlutech's proprietary technology allows 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 allows fast, atraumatic, minimally invasive closure of these defects. ASD closure using implantable devices is an alternative to open heart surgery.