EndoShape Receives 510(k) Clearance for Polymer Embolization Device
BOULDER, Colo., Nov. 7, 2013 /PRNewswire/ — EndoShape said Monday that it has received 510(k) marketing clearance for its Medusa(TM) Vascular Plug.
The Food and Drug Administration cleared the catheter-delivered device 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.
The Medusa(TM) Vascular Plug is deployed through a catheter placed in the patient’s bloodstream and occludes vessels in a single delivery sequence.
Due to its non-metallic nature, the Medusa(TM) Vascular Plug produces minimal CT (Computed Tomography) artifact.
Boulder-based EndoShape said it would launch the device in the U.S. in early 2014.