Micro Interventional Devices initiates STASIS first-in-man clinical study of Permaseal


Micro Interventional Devices has announced that the first patient has been treated using its self-sealing, cardiac access and closure technology, Permaseal. The patient is the first to be enrolled in the company’s European STASIS clinical trial.

Rudiger Lange, director of the Department of Cardiovascular Surgery, The German Heart Center, Munich, Germany, and principal investigator of the study performed the first procedure.

Designed as a non-randomised, multicentre, CE mark study, STASIS (Sutureless transapical access and closure study) will evaluate the safety and performance of Permaseal for left ventricular transapical access and closure. The study will be conducted at five sites within the European Union (EU) and will enrol 40 patients scheduled for a transapical transcatheter aortic valve replacement procedure utilising Edward’s Sapien XT. Micro Interventional expects top-line data from the trial to be available by the first quarter of 2013.

“This marks the initiation of the first human safety and performance study for the Permaseal device. The need for a safe, reliable and easy-to-use access and closure device for structural heart repair procedures, specifically during transcatheter aortic valve implantation (TAVI), is well known. I am honored to play a lead role in the development of this potential solution to transapical access site complications,” said Lange.

Permaseal is the first transapical access device to enable true self-sealing, sutureless cardiac access and closure. The technology combines soft tissue anchors and advanced biocompatible elastomers that form a “web” around the myocardial access site. The device is applied to the myocardium prior to the procedure and provides haemostatic access to the left ventricle during minimally invasive cardiac procedures.

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. Permaseal is designed for a range of structural heart repair procedures including and mitral valve repair.

Wilson Szeto, University of Pennsylvania, will include Permaseal in his presentation titled “LV Apical Closure Devices” during the “Innovative Surgical Techniques and Technologies” session of the Transcatheter Cardiovascular Therapeutics (TCT) Conference in Miami, USA, on 24 October.