FDA Gives Green Light to St. Jude’s Embolic Protection System, Flow Control Device


July 26, 2007

July 26, 2007 - St. Jude Medical Inc. announced that the FDA has granted clearance for the 7F Proxis Embolic Protection System, a system designed 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 Embolic Protection System provides protection proximally, or "upstream," from an SVG blockage. As stenting may dislodge debris that flows downstream, thus increasing the risk of heart attack, stroke or other complications, the embolic protection system is engineered to extract dislodged debris. Additionally, the Proxis Embolic Protection System allows cardiologists to remove dislodged debris floating in the bloodstream.
The system 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 before delivering the interventional device to the diseased area. Once the intervention is complete, fluid and debris are aspirated from the vessel.
In a related story, the FDA cleared St. Jude Medical for its 6F Proxis Flow Control System, a smaller device for controlling the flow of fluids in the coronary and peripheral vasculature by temporarily suspending blood flow within a vessel. This technique assists clinicians in visualizing the lesion or delivering other therapies.

For more information: www.sjm.com