CryoLife, an implantable biological medical device and cardiovascular tissue processing company, has entered into a worldwide distribution and manufacturing agreement with Starch Medical (SMI) for PerClot, a polysaccharide hemostatic agent used in surgery.
PerClot is an absorbable powder hemostat that has CE mark designation allowing commercial distribution into the European Community and other markets.
Hemostat 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 plans to file an investigational device exemption (IDE) with the US Food and Drug Administration to begin clinical trials for the purpose of obtaining Pre-Market Approval (PMA) to distribute PerClot in the US.
CryoLife president and chief executive officer Steven Anderson said that PerClot is an exciting technology platform that has already seen significant success in Europe and its unique formulation allows for full and rapid absorption, while showing excellent hemostatic capabilities.
“We are very pleased to have secured the rights to this second generation hemostatic agent and its laparoscopic delivery devices via an agreement that will allow us to serve a broader range of medical specialties and leverage the continued opportunities in the large and growing hemostatic agent market,” Anderson said.