US-based EndoShape has received 510(k) marketing clearance from the Food and Drug Administration (FDA) for its Medusa vascular plug, designed for arterial and venous embolization in the peripheral vasculature.
The FDA cleared the catheter-delivered device is based on EndoShape’s proprietary polymer material technology.
The Medusa vascular plug is deployed through a catheter placed in the patient’s bloodstream and occludes vessels in a single delivery sequence.
The non-metallic nature of the Medusa vascular plug produces minimal CT (Computed Tomography) artifact.
According to the company, approximately 50,000 Americans have peripheral vascular embolization procedures annually for a wide variety of indications.
The company expects to launch the device in the US in early 2014.