FDA Approves Ostial Pro Stent Positioning System
June 13, 2007 - Ostial Solutions LLC announced that it has received FDA 510(k) clearance to market the Ostial Pro Stent Positioning System, a device that allows physicians to more accurately place a stent in selected coronary and renal procedures.
Ostial Pro has tiny gold-plated feet, which can be braced against an opening near a narrowed or closed artery. The system is designed to assist in implanting the stent at the correct location for maximum benefit with an accuracy of plus or minus 1 millimeter.
The FDA approval is for treatment of a subset of arterial diseases called aorta-ostial. According to R. Kevin Plemmons, president and CEO of Ostial Solutions LLC, aorta-ostial procedures are complex cases, in which physicians miss hitting the "true" ostium in as much as 50 percent of their cases. Plemmons argues that there is a need for a device that would allow for precise stent implantation.
For more information: www.ostialsolutions.net