Technology Protects Patients with SVG
St. Jude Medical, Incorporated received FDA approval to market a new device intended to protect individuals who have a saphenous vein graft (SVG) from previously performed heart bypass surgery. The device is used to remove debris that occurred during SVG procedures.
The Proxis Embolic Protection System is comprised of a catheter that includes a vessel-sealing balloon and an inflation device. The balloon is inflated past the lesion to halt blood flow during the procedure. The surgeon then completes the SVG procedure.
Following completion of such, the debris that results from the procedure is collected and removed along with fluid as necessary. Debris dislodged during the procedure that enters the bloodstream can be captured with the tool. Air is removed from the balloon to reduce blood flow to the vessel and the device is removed.
The product additionally, may be have improved capabilities to capture debris compared to existing tools that use mesh filters. Those can become clogged or fail to capture debris entirely.
Studies evaluating product efficacy indicated equivalency with devices already on the market that protect distally. This is the first FDA approved system that confers protective effects proximally. The Proxis, also, offers a superior side effect profile with a reduced incidence of major cardiac adverse events.
SVG procedures are performed on persons who have cardiac disease following bypass surgery that affects the new graft, such as placement of a stent to re-open the SVG. Almost one quarter million patients undergo SVG procedures annually. The improved side effect profile of the Proxis may enable more patients to undergo such procedures safely.
Related story: Embolic Protection Device for Saphenous Vein Graft Angioplasty Gets FDA Clearance
July 26, 2007 Related topics: New Technology & Innovation, Quality, Safety, Errors, Cardiology