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.