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510(k) Data Aggregation
K Number
DEN150029Device Name
Permaseal
Manufacturer
Date Cleared
2016-07-27
(401 days)
Product Code
Regulation Number
870.4510Why did this record match?
Product Code :
PNQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Permaseal is indicated for soft tissue approximation of cardiac apical tissue during transcatheter valve replacement procedures.
Device Description
The Permaseal device is composed of a delivery device and an implant that is deployed to facilitate access and closure. The deployment site is accessed via minimally invasive surgery or percutaneous surgery. The device is compatible with a 0.025" guide wire. The implant is designed to close punctures, incisions or ostomies in the cardiac apical tissue up to 30F, or 10mm in diameter.
The device features a handle designed to facilitate proper device placement and allow for singlehanded deployment of the implant. The handle contains a trigger that actuates the device and incorporates a mechanical safety. The handle functions as a tool to grip and position the device. It contains the actuating mechanism to control deployment of the anchor using a trigger mechanism.
The implant is composed of an array of eight polypropylene anchors connected by a 2-0 braided, coated polyester suture U.S.P, as seen in Figures 2 and 3. The suture was separately cleared to market through K021019.
The suture is threaded through the eyelets of the eight anchors in a circular pattern and terminates in a surgical knot. The excess suture provided is referred to as the loop limb. The opening that is formed in the center of the implant is referred to as the 'operative window.' The knot is tightened at the end of the procedure by advancing the knot pusher toward the implant. The knot pusher is shown in Figure 4. above. The knot pusher is affixed to the insertion tube by the knot pusher retainer and is removed from the tube before the implant is deployed.
Upon release of the safety and actuation of the trigger, a spring-loaded pusher tube connected distally to 8 pusher pins is released, transmitting the force of the spring through the pusher pins to the anchors, simultaneously embedding the 8 anchors firmly into the tissue at the target site.
The anchors are deployed at a pre-determined depth with the sutures resting on the surface of the heart. Once deployed, the polyester suture and eight anchors create an 'operative window' in a pattern approximating that of a purse-string suture pattern. The anchors provide a secure attachment site for the suture that connects the multiple anchors together. The suture serves as a means to bring the incised tissue edges into apposition so as to close the puncture. Advancing the surgical knot in the suture with the knot pusher creates sufficient tension on the anchors to pull them and the tissue together so as to close punctures, incisions or otomies in the cardiac apical tissue up to 30F, or 10mm in diameter.
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