CryoLife Receives 510(k) Clearance For PerClot Topical Hemostatic Powder

(RTTNews) - CryoLife, Inc. (CRY), a medical device and tissue processing company focused on cardiac and vascular surgery, Tuesday said it has received 510(k) clearance for PerClot Topical hemostatic powder from the U.S. Food and Drug Administration.

This clearance allows CryoLife to begin commercialization of PerClot Topical hemostatic powder in the U.S.

The company plans to begin shipping PerClot Topical hemostatic powder in June.

PerClot Topical is ready to use, requiring no mixing and/or other components and does not need special handling or storage conditions.

Preclinical evaluations have shown the effectiveness of PerClot Topical to be comparable to the current popular choice of surgical hemostatic materials, the firm noted.

The management estimates the U.S. hemostatic market for PerClot Topical in procedures included in the 510(k) clearance to be in excess of $100 million. The U.S. hemostatic market for all procedures is estimated to have been $780 million in 2013, growing to approximately $915 million by 2016.