CryoLife, a tissue processing and medical device company focused on cardiac and vascular surgery, has received conditional approval of its Investigational Device Exemption (IDE) for PerClot from the FDA.
PerClot is a unique 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.
"Subject to satisfaction of the FDA's conditions, we plan to begin enrollment in the trial in the third quarter and hope to have pre-market approval in 2015,” said Steven G. Anderson, CryoLife president and chief executive officer.
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.
The PerClot IDE is a prospective, multicenter, multidisciplinary, controlled clinical investigation. The objective of this investigation will the safety of PerClot versus a similar marketed hemostatic device in multiple surgical disciplines when used as an adjunct to conventional means such as pressure or ligature. The primary 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 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 refiling the IDE submission in July. The Company expects to begin enrollment in the general and urological surgical cohorts during the third quarter.