CryoLife Gains Conditional IDE for Hemostatic Device
CryoLife Inc., a Kennesaw, Ga.-based tissue processing and medical device company, has received conditional approval of its investigational device exemption (IDE) for Perclot from the U.S. Food and Drug Administration (FDA). Perclot is a hemostat composed of absorbable polysaccharide granules and is intended for use in surgical procedures as an adjunctive hemostatic device when control of capillary, venular, and arteriolar bleeding by pressure, ligature, and other conventional means is ineffective or impractical.
Perclot has CE mark designation and CryoLife began distributing Perclot in several international markets in the fourth quarter of 2010. Perclot international sales were up 34 percent in the first quarter of 2013 compared to the first quarter of 2012.
“We’re pleased to reach this initial milestone toward the commercialization of Perclot in the U.S.,” said Steven G. Anderson, CryoLife president and CEO. “Subject to satisfaction of the FDA’s conditions, we plan to begin enrollment in the pivotal trial in the third quarter of 2013, and hope to have pre-market approval in 2015.”
The U.S. hemostatic market is estimated to be $889 million in 2012 growing to approximately $1.1 billion in 2014, while the European market is estimated to be $361 million in 2012 growing to approximately $430 million in 2014, according to iData.
The Perclot IDE is a prospective, multi-center, multidisciplinary, controlled clinical investigation. The primary objective of this investigation will be to collect clinical data concerning the safety and efficacy of Perclot versus a similar marketed hemostatic device in multiple surgical disciplines when used as an adjunct to conventional means of achieving hemostasis such as pressure or ligature. The primary efficacy endpoint of this investigation will be achievement of hemostasis at the site of application at five minutes following application of the prescribed hemostatic agent. The secondary efficacy endpoint for this investigation will be hemostasis at the site of application evaluated at two minutes. Safety endpoints will include, but are not limited to, the incidence of reoperation due to bleeding, total hospitalization and procedure time, and the incidence of procedure complications and/or adverse events through final patient follow-up.
As part of the conditional approval for the Perclot IDE, CryoLife must make certain revisions to the investigational study protocol, clinical product labeling and patient informed consent forms. The company anticipates re-filing the IDE submission in July, and expects to begin enrollment in the general and urological surgical cohorts during the third quarter. According to CryoLife officials, the company aims to have further discussions with the FDA to clarify the requirements prior to enrollment in the cardiac and orthopedic indications.
Perclot is a medical device composed of absorbable polysaccharide granules and delivery applicators. The granules are biocompatible, non-pyrogenic, and derived from purified plant starch. The granules do not contain any human or animal components. Perclot granules have a molecular structure that rapidly absorbs water, forming a gelled adhesive matrix that provides a mechanical barrier to further bleeding and results in the accumulation of platelets, red blood cells, and coagulation proteins (such as thrombin and fibrinogen) at the site of application. One gram of Perclot absorbs at least 19 mL of water, according to the company. The gelled adhesive matrix thus promotes the normal physiological clotting cascade. Perclot granulaes are enzymatically degraded by alpha-amylase and glucoamylase and by macrophages. Based on preclinical studies, absorption normally requires several days and is dependent on the amount of material applied on the wound and the site of use.
Perclot is intended for use in surgical procedures as an adjunctive hemostatic device when control of capillary, venular, and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical.