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April 4, 2011 /PRNewswire/ -- CryoLife, Inc. (NYSE: CRY), an implantable biological medical device and cardiovascular tissue processing company, announced today that
it has filed an IDE with the United States Food and Drug Administration (FDA) to begin clinical trials for the purpose of obtaining Pre-Market Approval (PMA) to distribute PerClot in the U.S. to control bleeding during surgical procedures or following traumatic injuries.
PerClot is a unique, absorbable powder hemostat and is intended for use in surgical procedures when control of bleeding by pressure, ligature, and other conventional means is either ineffective or impractical. The therapeutic areas in which PerClot will be used consist of cardiac, general, urological, orthopedic, and neurosurgical procedures. PerClot has CE Mark designation and CryoLife began distributing PerClot in several international markets in the fourth quarter of 2010.
"We're pleased to reach this milestone in the commercialization of PerClot in the U.S.," stated
Steven G. Anderson, CryoLife president and chief executive officer. "We plan to begin enrollment in the pivotal trial later this year and hope to have pre-market approval no later than 2013."
The U.S. hemostatic market is estimated to be
$732 million in 2010 growing to approximately
$1.1 billion in 2014, while the European market is estimated to be
$279 million in 2010 growing to approximately
$430 million in 2014.(1)
CryoLife's proposed IDE study would include a total of approximately 330 patients in a randomized, prospective, multicenter trial. The primary objective would be to evaluate the hemostatic effectiveness of PerClot versus control hemostatic devices (Gelfoam® and Surgicel®) at 5 minutes. Efficacy would be assessed by comparing intraoperative time to hemostasis (primary endpoint). The secondary objectives would be to evaluate the proportion of subjects with hemostasis at 1, 3, 7, and 10 minutes after trial treatment. Safety endpoints would include but are not limited to the incidence of reoperation due to bleeding, total hospitalization time, and the incidence of procedure complications and/or adverse events through final patient follow-up.