CryoLife, a US-based tissue processing and medical device company, has secured conditional US FDA approval of its Investigational Device Exemption (IDE) for PerClot.
A hemostat made of absorbable polysaccharide granules, PerClot is designed 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 either ineffective or not possible.
CyroLife received CE Mark approval for PerClot and began distributing it 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 same period of 2012.
The hemostatic market was worth $889m in 2012 in the US and is expected to touch about $1.1bn in 2014, while the European market was valued at $361m in 2012 and expected to grow to about $430m in 2014.
The PerClot IDE is a multicenter, multidisciplinary, controlled clinical investigation, which aims to gather clinical data concerning the safety and efficacy of PerClot against a similar marketed hemostatic device in multiple surgical disciplines when used as an adjunct to traditional means of achieving hemostasis such as pressure or ligature.
CryoLife president and CEO Steven Anderson said, "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."