Micro Interventional Devices has treated the first patient in sutureless transapical access and closure study (STASIS) using its transapical access device, designed to provide hemostatic access to the left ventricle during minimally invasive cardiac procedures.
The self-sealing, cardiac access and closure system, Permaseal, features soft tissue anchors and biocompatible elastomers that form a web around the myocardial access site.
Once the procedure is completed and the cannula and guide wire are extracted, the Permaseal webbing constricts around the opening in the heart, providing instantaneous closure while allowing for flexibility to accommodate a beating heart, according to the company.
The multi-centre, non-randomised, CE-mark study will enrol 40 patients to evaluate the safety and efficacy of Permaseal for left ventricular transapical access and closure.
German Heart Centre cardiovascular surgery department director and study principal investigator professor Dr Rudiger Lange said the need for a safe, reliable and easy-to-use access and closure device for structural heart repair procedures is widely acknowledged.
"I am honored to play a lead role in the development of this potential solution to transapical access site complications," Lange said.
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 commercialise 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.