Micro Interventional Devices has initiated first-in-man Sutureless Transapical Access and Closure study (STASIS) trial to demonstrate the efficacy of its transapical access device in providing hemostatic access to the left ventricle during minimally invasive cardiac procedures.
The self-sealing, cardiac access and closure device, Permaseal, features soft tissue anchors and biocompatible elastomers that form a web around the myocardial access site.
The company said once the procedure is completed and the cannula and guide wire are extracted, the Permaseal webbing constricts around the opening in the heart and provides instantaneous closure, while allowing for flexibility to accommodate a beating heart.
The multi-center, non-randomized, CE-mark study, which will enroll 40 patients, is designed to evaluate the safety and efficacy of Permaseal for left ventricular transapical access and closure.
Micro Interventional Devices president and CEO Michael Whitman said, "We look forward to completing STASIS and collecting the data from our first clinical study as an important step in our effort to commercialize the technology and provide a safer, less-invasive access and closure platform to patients undergoing cardiac surgery."
The company expects the trial data to be available by the first quarter of 2013.