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FDA Clears EndoShape Vascular Plug

The device will be released next year.

Boulder, Colo.-based EndoShape Inc. has received 510(k) clearance from the U.S. Food and Drug Administration for its Medusa vascular plug. The catheter-delivered device was cleared for arterial and venous embolization in the peripheral vasculature. The device is based on EndoShape’s proprietary polymer material technology.

Roughly 50,000 Americans have peripheral vascular embolization procedures annually for a wide variety of indications, such as a ruptured vessel bleeding into the patient’s body or to close off a blood vessel that could be feeding a tumor.

The Medusa vascular plug is deployed through a catheter placed in the patient’s bloodstream and is designed to occlude vessels in a single delivery sequence. 

Due to its non-metallic nature, the Medusa Vascular Plug produces minimal CT (Computed Tomography) artifact (issues that obscure the CT image).

EndoShape is planning for an early 2014 U.S. launch for Medusa.


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