News | June 07, 2007

FDA Approves Ostial Pro Stent Positioning System

June 8, 2007 — The FDA has given approval for a device that allows physicians to more accurately place a stent in selected coronary and renal procedures.

"The Ostial Pro Stent Positioning System has very broad applications," R. Kevin Plemmons, President and CEO of Ostial Solutions LLC, said. "We estimated that the device can be used in 90% to 95% of all renal aorta-ostial procedures and 7% of all coronary aorta-ostial procedures."

The FDA approval is for treatment of a subset of arterial diseases called aorta-ostial. It refers to disease that occurs at the joining, called the ostium, of a smaller artery with a major artery such as the aorta.

Ostial Pro has tiny gold-plated "feet," which open like a flower in bloom and can be braced against an opening near a narrowed or closed artery. Often the offending plaque is difficult to visualize in angiography and the system greatly increases the likelihood that the stent will be implanted at the correct location for maximum benefit with an accuracy of plus or minus 1 millimeter.

Plemmons said that the plus or minus 1 millimeter tolerance is critical to the optimum success of the procedure.

The Ostial Pro Stent Positioning System is a medical-grade catheter that can be used by interventional cardiologists, radiologists and vascular surgeons, Plemmons said. It can be used in conjunction with any manufacture’s approved stent delivery system.

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