Conditional IDE Approval For CryoLife’s PerClot® Hemostat U.S. Study

A frequent visitor to our pages, Cardiovascular device company CryoLife, Inc., a leader in tissue processing, has received conditional approval of its Investigational Device Exemption (IDE) for PerClot from the US 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.

Background

PerClot is composed of absorbable polysaccharide granules and delivery applicators. The granules are biocompatible, non-pyrogenic, and derived from purified plant starch and 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 (thrombin, fibrinogen, etc.) at the site of application.

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.

PerClot is CE Marked and available in several international markets since 2010.

The study

The PerClot IDE is a prospective, multicenter, multidisciplinary, controlled clinical investigation with the primary objective being to collect safety and efficacy data. The study will compare Perclot with 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 5 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 2 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.

The “conditional” element of the approval is that 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 with enrollment in the general and urological surgical cohorts expected to begin during the third quarter.

Company comments

“We’re pleased to reach this initial milestone toward the commercialization of PerClot in the U.S.,” stated Steven G. Anderson, CryoLife president and chief executive officer. “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.”

Source: CryoLife, Inc., PR Newswire