Permaseal™ is a novel device designed to facilitate safe and reliable, sutureless transmyocardial access and spontaneous closure during structural heart repair procedures such as transapical TAVR.
The device is delivered to the epicardial surface of the heart via mini-thoractomy or percutaneously. The current Permaseal product is designed to create access to the left ventricle for devices of up to 28F. Once the 28F or smaller device is removed from the ventricle, Permaseal spontaneously closes the access site without sutures or other surgical intervention.
The Permaseal Device allows for a minimally invasive footprint that is reproducible time and time again, regardless of the operator. Not only does the device conform to different instrument sizes, comply with the beating heart so as not to interfere with wall motion and leave little foreign material behind, it closes spontaneously upon device removal, without requiring fast-pacing. This reliable access and closure approach will reduce OR time, abate blood loss, and simplify complex structural heart repair procedures, ultimately enabling a conversion from surgical procedures to fully percutaneous catheter lab-based procedures.
No other transapical closure device delivers all of the following benefits:
CAUTION: Exclusively for Clinical Investigations. This device is not sold or offered for sale in the U.S.