The Food and Drug Administration has given approval for a Kalamazoo, MI-based company to begin marketing a one-of-a-kind device that allows physicians to more accurately place a stent in selected coronary and renal procedures.
R. Kevin Plemmons, President and CEO of Ostial Solutions LLC, said his firm expects to begin marketing the Ostial Pro Stent Positioning System by mid-June.
“The Ostial Pro Stent Positioning System has very broad applications,” said Plemmons, who received word of the FDA approval in late May. “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 under the agency?s 510(k) Section, which requires minimal animal and human clinical data.
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.
There will be roughly 65,000 renal aorta-ostial procedures performed in 2007 and 1.4 million coronary aorta-ostial procedures. Although the device may be limited to 7% of coronary the procedures, that still represents nearly 100,000 procedures a year.
Aorta-ostial procedures are complex and very challenging cases, he said, and physicians miss hitting the ?true? ostium in as much as 50% of their cases, underscoring the need for a device that would allow for precise stent implantation.
Plemmons said that the Ostial Pro Stent Positioning System is the first and only one of its kind. It was tested in a small number of animals and humans prior to FDA approval.
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.
A stent is a tiny metal mesh tube carried by a balloon-tipped catheter to the site of a narrowed or blocked artery. When the balloon is inflated, it both opens the artery and increases the diameter of the stent. Once the balloon is deflated and removed, the stent remains fully extended and in place to prop open the artery and restore blood flow.
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.
Ostial Pro was developed by Dr. Tim A. Fischell, an interventional cardiologist in Kalamazoo who serves as Ostial Solutions’ Chief Scientific Officer. Fischell began work on the system after a encountering a number of difficult stent-placing procedures.
If the stent is placed too distal to the narrowing another stent may be needed, a cost that must be absorbed by the hospital. If the stent is placed to proximal to the ostium the stent will protrude into the aorta preventing further intervention and leaving bypass surgery as the patient?s only option.
Work on the design for the Ostial Pro Stent Positioning System began in 2003, Plemmons said, with a more concentrated effort starting in late 2005.
Fischell is Professor of Medicine at Michigan State University and the medical director of the Borgess Heart Institute Department of Cardiovascular Research and the Interventional Cardiology Fellowship Program.
He is the inventor or co-inventor of more than 70 patented medical devices. Fischell and his father, Robert, and brother, David, have invented a radioisotope stent, several stent-delivery systems, a number of pioneering stent designs and an implantable heart-attack detection system.
One Fischell-designed stent is the platform for the Johnson & Johnson drug eluding stent, Cypher, which dramatically reduces the likelihood of restenosis following angioplasty.