CryoLife, an implantable biological medical device and cardiovascular tissue processing company, has begun European distribution of PerClot, a polysaccharide hemostatic agent used to control bleeding during surgical procedures or following traumatic injuries.
PerClot is indicated for use in surgical procedures, including cardiac, vascular, orthopedic, spinal, neurological, gynecological, 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 president and CEO Steven Anderson said that PerClot is a technology platform that has seen success in Europe already, and they are pleased to begin offering this product in France.
“Our international and largely unrestricted distribution agreement allows us to address a very broad range of medical specialties in the growing hemostatic agent market. We look forward to expanding distribution within the European Union and many other markets around the world in the coming months,” Anderson said.
CryoLife plans to file an investigational device exemption (IDE) with the US Food and Drug Administration (FDA) to begin clinical trials for the purpose of obtaining Pre-Market Approval (PMA) to distribute PerClot in the US.