Micro Interventional Devices (Newtown, PA) received FDA clearance to introduce its Permaseal device. The tool is used to create an opening into the left ventricular cavity*for delivery of interventional instruments and to then close following the procedure. The PolyCor anchoring tech**logy employed by the Permaseal makes manual suturing of the myocardium unnecessary.
The tool deploys eight anchors, all connected together by a suture, into the heart tissue. The anchors slice open a hole, and when ready the suture is pulled on to bring the anchors together and close the opening.
From Micro Interventional Devices:
Permaseal was validated in the STASIS Clinical Study (Secure Transapical Access and Closure Study) conducted at five European Sites. Results indicated that Permaseal shortened operating time and hospital stay, reduced adverse events including the need for transfusion and reduced 12-month mortality and stroke rates to 0%. The tech**logy provides a direct, safe and simple, Access and Closure site for emerging complex structural heart disease procedures including TAVR, TMVR, PFO, and other minimally invasive cardiac procedures.
08-03-2016, 10:52 PM
Permaseal Transapical Access and Closure Device Gets FDA Green Light
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