CryoLife announced on 19 June 2013 that it has received conditional approval of its investigational device exemption (IDE) for PerClot from the FDA. PerClot is a haemostat composed of absorbable polysaccharide granules and is intended for use in surgical procedures as an adjunctive haemostatic 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% in the first quarter of 2013 compared to the first quarter of 2012.
“We are pleased to reach this initial milestone toward the commercialization of PerClot in the USA,” stated Steven G Anderson, CryoLife president and chief executive officer. “Subject to satisfaction of the FDA’s conditions, we plan to begin enrolment in the pivotal trial in the third quarter of 2013, and hope to have pre-market approval in 2015.”
The US haemostatic market is estimated to be US$889 million in 2012 growing to approximately US$1.1 billion in 2014, while the European market is estimated to be US$361 million in 2012 growing to approximately US$430 million in 2014.
The PerClot IDE is a prospective, multicentre, 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 haemostatic device in multiple surgical disciplines when used as an adjunct to conventional means of achieving haemostasis such as pressure or ligature. The primary efficacy endpoint of this investigation will be achievement of haemostasis at the site of application at five minutes following application of the prescribed haemostatic agent. The secondary efficacy endpoint for this investigation will be haemostasis 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 labelling and Patient Informed Consent forms. The Company anticipates refilling the IDE submission in July. The Company expects to begin enrolment in the general and urological surgical cohorts during the third quarter. The company will have further discussions with the FDA to clarify the requirements prior to enrolment in the cardiac and orthopaedic indications.