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 lengths to limit balloon overhang to 1 mm, thus greatly reducing the potential for what cardiologists describe as dog boning," said Penn. "To minimize the risk of stent embolization, Cordis proprietary Nesting technology secures the MINI to the delivery balloon until it is deployed."
"Clinical trial results show the MINI to be associated with a high rate of successful deployment, outstanding angiographic outcomes, and a very low rate of post-stenting major adverse cardiac events," said Dr. Williams. "While the MINI is an excellent stent for treating smaller vessels, I was also extremely impressed with its performance in vessels with lumen diameters of 3.0 mm to 3.25 mm."
Historically, most smaller vessel lesions have been treated with balloon angioplasty alone due to the small lumen size of these vessels and the increased risk of dissection. Dr. Williams noted that the use of large-vessel stent systems in small-diameter vessels generally doesn't allow for a proper stent-to-artery ratio when deployed.
The MINI is indicated for treatment of abrupt or threatened closure in patients with failed interventional therapy in native coronary lesions (less than or equal to 25 mm) with reference diameters in the range of 3.25 mm to 2.25 mm. *Non-compliant: Term used to describe balloon material that provides predictable and controllable expansion to minimize the risk of edge dissection. +Dog boning: Term used to describe the appearance of excessive expansion of the balloon on either end of the stent.
Cordis Cardiology is a subsidiary of Cordis Corporation, a broad-based supplier of products for circulatory disease management. Established in 1959, Cordis Corporation is the world's largest, most comprehensive developer and manufacturer of innovative products for interventional medicine, minimally invasive computer-based imaging, and electrophysiology. In 1996, Cordis Corporation merged with Johnson & Johnson to form Cordis, a Johnson & Johnson company, with approximately 3,500 employees worldwide.
To participate in an audioconference on Wednesday, April 21, from 10:00 to 11:00 AM (EST) with Dr. David Williams and Cordis Cardiology executives, please call 800-670-3547 (at 10:00 AM EST, April 21). Should you encounter any problems getting a connection, please call D.J. Storch & Associates at 908-273-1400.
*Complete taped audioconference can be heard April 21, between 12:00 and 8:00 PM (EST), by calling 800-633-8284. Callers will be prompted to enter the following access code number: 12198935.