FDA Clears St. Jude System

St. Jude Medical announced FDA clearance of its 7F Proxis Embolic Protection System. The system is intended to extract debris that becomes 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 “upstream” from an SVG blockage, the company said.

The system allows cardiologists to remove debris floating in the bloodstream, an advantage over other embolic protection devices, which can allow small particles to pass through a filter mesh or slip around the filter entirely, according to St. Jude. Conventional filters can also be overwhelmed by large amounts of debris, causing them to clog or overflow, the company added.

The system is already approved in Europe and Canada.