Perclose ProGlide suture-mediated closure system FDA approval

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Abbott has gained FDA approval for its Perclose Proglide suture-mediated closure system. The device is designed to close access sites created by large bore catheters, stopping the blood flow. 

The ProGlide is used after the insertion of large bore catheters in catheterisation procedures in the femoral vein or artery. The device is able to close access sites ranging from about 0.07 inches to 0.32 inches in diameter, The US FDA states.

The closure system is composed of a plunger, handle, guidewire, and sheath. The device is designed to deliver a single suture to close the access sites in the femoral vein or artery following catheterisation procedures. The placement of a suture where the catheter was inserted will prevent blood flow until the access site heals.

The ProGlide is placed over a guidewire, inserting the end of the device into the blood vessel. The surgeon presses the plunger and lever on the handle of the device, which maneuver the suture to create a stitch across the access site. In some cases (3 out of 10), in addition to the ProGlide stitch, pressure may need to be applied to the access site to fully stop blood flow. When catheters larger than about 0.1 inches in diameter are used during the catheterisation procedure, two ProGlide devices are necessary to close the access site.

The FDA state that the ProGlide device will seal the opening created by the catheter at the access site either with or without additional pressure applied to the stop blood flow.

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