FDA Clears Coronary Artery Stent Specifically Engineered For Smaller Vessels
MIAMI, FL (April 19, 1999) -- Cordis Cardiology today announced U.S. Food and Drug Administration approval to market its new MINI Crown stent (the MINI) specifically engineered for smaller coronary vessels (lumen diameters from 3.25 mm to as small as 2.25 mm). Cordis Cardiology is a unit of Cordis Corporation, a Johnson & Johnson company.
According to David O. Williams, M.D., Division of Cardiology, Rhode Island Hospital, Providence, RI, who served as principal investigator in the clinical trial of the MINI, many physicians view smaller vessel stenting as the next frontier in interventional cardiology.
"There's no question that there is high physician demand for a quality smaller vessel stent," said Dr. Williams. "I find the MINI to be the best choice for stenting smaller vessels. It offers many unique advantages, such as one-step deployment, a low-profile delivery system, minimal balloon overhang, and precise balloon sizing at higher pressures -- all of which, in my opinion, make the procedure safe."
Jesse Penn, president, Cordis Cardiology, said the company initially will offer the MINI in 11 mm and 15 mm lengths and diameters ranging from 3.25 mm to 2.25 mm in quarter sizes. Penn described the MINI as the stent that enables physicians to "go smaller safely," predicting that it will soon become the "gold standard" for smaller vessel stenting.
Penn also explained that the MINI and the DynastyTM; delivery system have been carefully designed to respond to the need for a stenting system that offers easy deliverability in patients with small, tight lesions while minimizing the risks of edge dissection and stent embolization.
"We're addressing the issue of edge dissection by 1) using the new
non-compliant DURAMAX balloon material to control expansion and
2) closely matching balloon and stent
Contact: Robert Murphy
D. J. Storch & Associates Inc.