CryoLife, an implantable biological medical device company, has received Shonin approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for its BioGlue surgical adhesive, for use in the repair of aortic dissections.
CryoLife’s partner Century Medical Inc (CMI) will distribute BioGlue in Japan for use in the subset of cardiac surgery.
MHLW, prior to distribution, need to complete certain additional steps like an on-site inspection of CryoLife pursuant to Japanese Quality Management System requirements and required product reimbursement paperwork for Japanese authorities.
CMI president and chief executive officer Akira Hoshino said that they are pleased to have received Japanese approval for the use of BioGlue in the repair of aortic dissections and believe that BioGlue is a valuable tool that will address many issues facing cardiac surgeons in Japan.
CryoLife president and chief executive officer Steven Anderson said that they are pleased that BioGlue is approved for this initial use in Japan and estimate Japan to be the second largest market in the world for surgical hemostats and sealants.