ATLANTA, Oct. 7 /PRNewswire/ — CryoLife, Inc. (NYSE:
CRY), an implantable biological medical device and
cardiovascular tissue processing company, today announced that its
BioGlue Surgical Adhesive has received Shonin approval from the
Japanese Ministry of Health, Labor and Welfare (MHLW) for use in
the repair of aortic dissections.
CryoLife’s partner Century Medical, Inc. (CMI) will distribute
BioGlue in Japan for use in this subset of cardiac surgery.
Prior to distribution, MHLW will need to complete certain
additional steps, most notably an on-site inspection of CryoLife
pursuant to Japanese Quality Management System requirements and
required product reimbursement paperwork for Japanese authorities.
As a result, management estimates that distribution in Japan
will begin in the first half of 2011. CryoLife will remain
the exclusive supplier of BioGlue to CMI.
“We are pleased to have received Japanese approval for the use
of BioGlue in the repair of aortic dissections, a potentially
life-threatening condition if not properly repaired,” stated Mr.
Akira Hoshino, president and chief executive officer of CMI.
“We believe that BioGlue is a valuable tool that will address
many issues facing cardiac surgeons in Japan.”
“We are pleased that BioGlue is approved for this initial use in
Japan. We estimate Japan to be the second largest market in
the world for surgical hemostats and sealants,” said Steven G.
Anderson, president and chief executive officer, CryoLife, Inc.
“Estimated to have been used in more than 600,000 procedures
worldwide, BioGlue has proven to be a safe, efficacious product,
and we look forward to continuing to expand both its applications
and availability worldwide.”
The company estimates that the annual Japanese market for the
use of surgical adhesives in the repair of aortic dissection is