CryoLife, Inc. (CRY) announced the Japanese Pharmaceuticals and Medical Device Agency has approved an expanded indication for BioGlue, a surgical adhesive used in cardiovascular surgery. BioGlue is now indicated for adhesion and support of hemostasis for aortotomy closure sites, suture/anastomosis sites, and suture sites on the heart.
BioGlue was previously approved for aortic dissection procedures in Japan. The company said the expanded indication potentially doubles the estimated BioGlue market opportunity in Japan to over $10 million.
CryoLife said its marketing partner in Japan, Century Medical, is expected to begin selling BioGlue in the third quarter of 2015 for the expanded indications.
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