FDA News

t. Jude Medical's Proxis Embolic Protection System Gets FDA Approval

(July 30, 2007)--St. Jude Medical announced U.S. Food and Drug Administration (FDA) clearance of the 7F Proxis Embolic Protection System.

The Proxis Embolic Protection System 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 Embolic Protection System is the first FDA cleared embolic protection system to provide protection proximally, or “upstream,” from an SVG blockage.

Approximately 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.

“Embolic protection has become an important part of caring for my patients. With proximal protection with the Proxis device, I am able to treat a wider range of patients that I was unable to treat previously,” said Daniel Dadourian, M.D., Hahnemann University Hospital, Philadelphia, Penn., the first physician to use the Proxis System post-FDA clearance. “Proxis is a welcome addition to my interventional procedures. It is intuitive to use and offers some dramatic advantages over traditional embolic protection technology.”

The Proxis Embolic Protection System allows cardiologists to remove dislodged debris floating in the bloodstream. This is an advantage over other embolic protection devices which can allow small particles to pass through a filter mesh or slip around the filter entirely. Conventional filters can also be overwhelmed by large amounts of debris, causing them to clog or overflow.

The Proxis Embolic Protection 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. 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.

The clinical data from the PROXIMAL Trial, presented at TCT 2005 (Transcatheter Cardiovascular Therapeutics), demonstrated the Proxis Embolic Protection System to be as effective as other systems previously cleared by the FDA. Trial data also showed lower rates of major adverse cardiac events with the Proxis Embolic Protection System than with distal (“downstream”) embolic protection devices.

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