A Medical Device Daily
St. Jude Medical (St. Paul, Minnesota) reported it has received FDA clearance of the 7F Proxis embolic protection system. The Proxis is intended to extract debris that may become dislodged when an intervention, such as delivering a stent, is performed on patients who have previously undergone a heart bypass procedure using a saphenous vein graft (SVG). The Proxis is the first FDA cleared embolic protection system to provide protection proximally, or "upstream," from an SVG blockage, the company said.
The Proxis includes an inflation device and a catheter with a vessel-sealing balloon. Cardiologists inflate the sealing balloon upstream to the lesion and temporarily suspend blood flow. With bloodflow suspended, the cardiologist delivers the interventional device to the diseased area. Once the intervention is complete, fluid and debris are aspirated, or removed from the vessel. The Proxis balloon is then deflated, restoring blood flow, and Proxis is removed from the SVG.
About 240,000 SVG interventions are performed worldwide each year, where patients with coronary blockages undergo bypass surgery in which a portion of the saphenous vein from the leg is sutured to the aorta, and to a coronary artery, to create a "bypass," or new passage for blood flow. If the SVG itself develops a blockage, interventional cardiologists often perform an interventional procedure, such as delivering a stent, to open the blocked SVG. However, stenting may dislodge debris that can flow downstream, or embolize, thereby increasing the risk of heart attack, stroke or other complications. Embolic protection systems are used to extract such dislodged debris.