Permaseal is composed of a high-speed delivery system that deploys an implant on the myocardium in 4/1000ths of a second. The 0.07gram implant, composed of eight PolyCor anchors and one 2-0 (3.0 metric) coated, non-absorbable, green braided polyester surgical suture, U.S.P., provides reliable and reproducible access and closure for structural heart repair procedures.
Permaseal is delivered to the myocardial surface of the heart via mini-thoracotomy. The product is designed to facilitate access to the left ventricle for delivery sheaths and/or catheters of up to 30F. Once the 30F or smaller device is removed from the ventricle, Permaseal is used to close the access site.
Permaseal allows for a minimally invasive footprint that is reproducible time and time again, regardless of the operator. The device is designed to allow for the passage of different instrument sizes, comply with the beating heart so as not to interfere with wall motion and leave little foreign material behind. This reliable access and closure approach may 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 and reducing the learning curve associated with these procedures.
No other transapical closure device delivers all of the following benefits:
CAUTION – Investigational Device Only. Limited by Federal (or United States) law to investigational use.
CAUTION. For Clinical Research ONLY. This device is NOT CE-marked and is to be used in Clinical Research Only.