PERCLOT® Polysaccharide Hemostatic System
In October, 2010, Starch Medical Inc. completed a licensing and exclusive worldwide distribution agreement excluding China, Taiwan, Hong Kong, Macau, North Korea, Iran and Syria with CryoLife, Inc. www.cryolife.com for the worldwide sales of the PerClot® Polysaccharide Hemostatic System for use in open and laparoscopic surgical procedures.
PerClot is a unique, absorbable powder hemostat that has CE Mark designation allowing commercial distribution into the European Community and other markets. It 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 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 U.S.
The PerClot® PHS Standard is available in 1g, 3g, and 5g AMP®configurations with a standard 100mm/200mm applicator. The system is delivered to the sterile field in a double barrier, sterile pouch and is intended as an absorbable hemostatic system to control bleeding during surgical procedures or following traumatic injuries. For more information, please visit http://perclot.cryolife.com.
PerClot® Laparoscopic is a hemostatic system designed for applications in minimally invasive surgical procedures. This system contains a unique instrument for precise delivery of AMP® particles through the laparoscope to the bleeding site. The 5mm diameter, 380mm long polypropylene instrument is easily attached to the PerClot® 3g bellow dispenser and enables hemostat delivery under direct vision. AMP® particles are biocompatible, non-pyrogenic and derived from purified plant starch. The device contains no human or animal components. For more information, please visit http://perclot.cryolife.com.