The announcement was reported during annual scientific sessions of the American Heart Association, in New Orleans, and it follows Cordis' market introduction last week of its new CHECKMATE(TM) Intravascular Brachytherapy System in the U.S. Cordis received regulatory approval for the Bx VELOCITY Stent with Hepacoat in Europe in June 2000 and in the United States from the U.S. Food and Drug Administration in late July 2000.
The Bx VELOCITY Coronary Stent with Hepacoat is indicated for improving coronary luminal diameter in the treatment of abrupt or threatened vessel closure in patients with failed interventional therapy in lesions (less than or equal to 30 mm in length) with reference diameters in the range of 2.25 mm to 4.00 mm.
"The Hepacoat surface coating has been widely tested on Cordis coronary stents in major global and U.S. clinical trials, including BENESTENT II, TOSCA, and Stent PAMI," said Jesse C. Penn, U.S. President, Cordis Cardiology. "The heparin coating on our Bx VELOCITY Stent with Hepacoat consists of end-point attached heparin, which freely interacts with the bloodstream. Due to covalent bonding, the heparin is firmly attached to the stent," Mr. Penn said.
Initially, market introduction of this next generation treatment will be a phased, limited distribution to hospital centers across the country, with full roll-out in the First and Second Quarters of 2001. Mr. Penn noted Cordis will make every effort to provide the Bx VELOCITY Stent with Hepacoat for special patient needs or circumstances under an allocation program.
"Introduction of our new Bx VELOCITY Coronary Stent with Hepacoat provides a significant new treatment option to physicians and patients," said Robert W. Croce, Company Group Chairman, Johnson & Johnson. "This treatment option is a key component of our long-term strategic commitment to innovation and advancements in interventional cardiology."
Known as Carmeda® BioActive Surface (CBAS), the proprietary heparin coating on the Bx VELOCITY Stent with Hepacoat retains its properties for periods lasting several months when implanted into blood vessels. This long-term bioactivity, coupled with stable heparin coating remaining on the surface of the device, differentiates it from other coatings designed to improve the hemocompatibility of blood-contacting devices. Carmeda®, of Sweden, developed the Carmeda® BioActive Surface.
"We are pleased Cordis carefully established the safety and efficacy of the Carmeda BioActive Surface heparin coating on its coronary stents, a demanding application for biomaterial coatings in light of the permanence of stents in the body," said Krister Ljungqvist, Managing Director of Carmeda.
Major clinical studies strongly suggest heparin-coated coronary stents offer improved care for patients," said Brian Firth, M.D., Ph.D., Cordis Vice President, Medical Affairs and Health Economics. "Now, another new generation of coated stents are entering clinical evaluation and will offer the potential for a truly dramatic change in outcomes following stent implantation."
Since its establishment in 1959, Cordis Corporation, along with its subsidiaries, has been a pioneer in circulatory disease management, and 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, it merged with Johnson & Johnson to form Cordis, a Johnson & Johnson company. For more information, contact: http://www.cordis.com. SOURCE Cordis, a Johnson & Johnson company
CONTACT: Press - David Swearingen, 732-524-3538, or Jeff Leebaw, 732-524-3350, or Investor - Helen Short, 732-524-6491, or Lesley Fishman, 732-524-3922, all of Cordis, a Johnson & Johnson company/