Vanguard IEP Peripheral Balloon Angioplasty System with Emboli Filter Cleared in U.S.

Contego Medical, based in Raleigh, North Carolina, landed FDA clearance for its Vanguard IEP peripheral balloon angioplasty system. The product features the Congego’s proprietary Integrated Embolic Protection (IEP) technology that captures embolic debris breaking off from occlusions being treated within the superficial femoral artery. It was cleared last year in Europe under the CE Mark. The IEP component is a parachute-like filter that captures anything larger than 150 microns in diameter, thanks to tiny pores that let blood through but blocks most of the plaque that can dislodge from an occlusion. The device enlarges to fill any sized arterial lumen, so can be used on a wide variety of patients to prevent serious side effects during balloon dilations. Once the dilation is performed, the parachute is closed and retracted with the rest of the catheter, removing the emboli from the body.