CryoLife, Inc., an implantable biological medical device and cardiovascular tissue processing company, announced that it has begun European distribution of PerClot, a novel polysaccharide haemostatic agent used to control bleeding during surgical procedures or following traumatic injuries.

"PerClot is an exciting technology platform that has seen success in Europe already, and we are pleased to begin offering this product in France," stated Steven G. Anderson, CryoLife president and chief executive officer. "Our international and largely unrestricted distribution agreement allows us to address a very broad range of medical specialties in the growing haemostatic agent market. We look forward to expanding distribution within the European Union and many other markets around the world in the coming months."

The European haemostatic market is estimated to be $279 million in 2010 growing to approximately $430 million in 2014.

On September 28, 2010, CryoLife entered into a worldwide distribution agreement and a manufacturing agreement with Starch Medical Inc. (SMI) of San Jose, California for PerClot, a unique, absorbable powder hemostat that has CE Mark designation allowing commercial distribution into the European Community and other markets. PerClot is indicated for use in surgical procedures, including cardiac, vascular, orthopaedic, spinal, neurological, gynaecological, ENT and trauma surgery as an adjunct hemostat when control of bleeding from capillary, venous, or arteriolar vessels by pressure, ligature, and other conventional means is either ineffective or impractical.

CryoLife plans to file an Investigational Device Exemption (IDE) with the United States Food and Drug Administration (FDA) to begin clinical trials for the purpose of obtaining Pre-Market Approval (PMA) to distribute PerClot in the US.

PerClot is a medical device composed of absorbable modified polymer (AMP) particles and delivery applicators. AMP particles are derived from purified plant starch. PerClot contains no human or animal components. It is intended for use as an absorbable haemostatic 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 haemostatic materials while its unique formulation allows for rapid absorption. PerClot particles are readily dissolved by saline irrigation and are degraded rapidly by human enzymes, primarily amylase, within several days.

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 US 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.