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Oct. 24, 2011 /PRNewswire/ --
CryoLife, Inc., (NYSE: CRY), a leading tissue processing and medical device Company focused on cardiac and vascular surgery, today announced that it has enrolled the first patient in its U.S. Investigational Device Exemption (IDE) clinical trial for its
BioFoam® Surgical Matrix protein hydrogel technology. In connection with the trial, BioFoam will be used as an adjunct to conservative measures of achieving hemostasis on newly resected liver parenchyma.
The approved IDE is for a prospective, multicenter, randomized feasibility study evaluating safety outcomes of BioFoam as compared to a standard topical hemostatic agent. The feasibility investigation will be conducted at up to three investigational sites and will enroll 20 eligible subjects with 10 subjects in each treatment group.
"We are pleased to begin enrolling patients in our IDE study, which is a milestone in our efforts to obtain BioFoam approval for distribution in the U.S.," said
Steven G. Anderson, CryoLife president and chief executive officer. "We have worked with FDA on two recent protocol amendments which we think should help speed enrollment into the pilot study. Once it is completed, assuming that the data is positive, we will begin planning for a larger pivotal study to support a PMA application for BioFoam with the FDA. We believe that BioFoam may hold promise for surgeons around the world and are encouraged by the early clinical experience in
Upon successful completion of the feasibility study in the U.S., and subsequent FDA and Department of Defense approvals, a follow-on prospective, multicenter, randomized, controlled pivotal study is planned. It is currently anticipated that the pivotal investigation would enroll a total of 164 eligible subjects, 82 subjects in each treatment group across a maximum of 10 investigational sites. This data would then be used to support a U.S. Premarket Approval application to allow commercialization of BioFoam in the U.S.