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CryoLife Files Investigational Device Exemption (IDE) to Begin Clinical Trials for PerClot® in the U.S.
Date:4/4/2011

condary objectives would be to evaluate the proportion of subjects with hemostasis at 1, 3, 7, and 10 minutes after trial treatment.  Safety endpoints would include but are not limited to the incidence of reoperation due to bleeding, total hospitalization time, and the incidence of procedure complications and/or adverse events through final patient follow-up.

About PerClot

PerClot is a medical device composed of absorbable polysaccharide particles and delivery applicators.  The particles are derived from purified plant starch.  PerClot contains no human or animal components.  It is intended for use as an absorbable hemostatic system to control bleeding during surgical procedures or following traumatic injuries.

PerClot is ready to use, requiring no mixing and/or other components and does not need special handling or storage conditions.  Pre-clinical evaluations, clinical studies and surgical use have shown the efficacy of PerClot to be comparable to the current popular choice of surgical hemostatic materials while its unique formulation allows for superior rapid absorption.  PerClot particles are degraded by human enzymes, alpha-amylase and glucoamylase, and by macrophages typically within several days.

About CryoLife, Inc.

Founded in 1984, CryoLife, Inc. is a leader in the processing and distribution of implantable living human tissues for use in cardiac and vascular surgeries throughout the U.S. and Canada.  The Company's CryoValve® SG pulmonary heart valve, processed using CryoLife's proprietary SynerGraft® technology, has FDA 510(k) clearance for the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves.  The Company's CryoPatch® SG pulmonary cardiac patch has FDA 510(k) clearance for the repair or reconstruction of the right ventricular outflow tract (RVOT), which is a surgery commonly performed in children wi
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SOURCE CryoLife, Inc.
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