Cordis' CYPHER™ Sirolimus-eluting Stent
Receives CE Mark Approval
First Drug-eluting Stent Treatment for Coronary Artery Disease Available in Europe
Brussels, Belgium (April 15, 2002) – Cordis Corporation, a Johnson & Johnson company, today reported its new CYPHER™ Sirolimus-eluting Stent received CE Mark approval in Europe for treatment of de novo coronary artery lesions (less than or equal to 30 mm in length) in native coronary arteries with reference diameters ranging from 2.25 to 5.0 mm.
"The CYPHER™ Sirolimus-eluting Stent has continued to demonstrate very positive results throughout its clinical trials in Europe and Latin America," said Robert W. Croce, Johnson & Johnson company group chairman responsible for the Cordis franchise. "We are extremely pleased that the CYPHER™ Stent can now be made available to patients throughout Europe."
CE Mark approval of the CYPHER™ Sirolimus-eluting Stent was issued by the British Standards Institution (BSI). This European regulatory approval was based on a comprehensive review of pre-clinical data, functional test data, and long-term clinical data, demonstrating sustainability of a low incidence of major adverse cardiac events (MACE) and maintenance of zero restenosis (no reblockage) through one-year follow-up in the pivotal European clinical trial.
"It is gratifying that we had strong, comprehensive long-term data to present to the BSI," Croce added.
In fulfillment of the requirement for clinical data, Cordis submitted the 12-month results of RAVEL*, a large-scale, randomized, double-blind, controlled clinical trial involving 238 patients from 19 hospitals across Europe and Latin America. The study was powered to detect a significant difference in a clinically meaningful endpoint at six months. Data presented for CE Mark approval included one-year follow-up with a significantly lower MACE rate compared with that of the control, a subacute thrombosis (SAT) rate comparable to that of the control, and a target lesion revascularization (TLR) rate significantly lower than that of the control.
Sirolimus, the active drug released from the stent, is a naturally occurring antibiotic marketed by Wyeth Pharmaceuticals (NYSE: Wyeth) under the name Rapamune** and used to prevent renal transplant rejection. Cordis has entered into an exclusive worldwide license agreement with Wyeth for delivery of sirolimus via a stent.
Cordis researchers chose sirolimus for its cytostatic, rather than cytotoxic, properties. The CYPHER™ Sirolimus-eluting Stent is designed to inhibit proliferating cells, not destroy them.
In addition to its planned European launch, Cordis will begin introducing the CYPHER™ Sirolimus-eluting Stent in other global markets where it is also cleared for sale.
The CYPHER™ Sirolimus-eluting Stent is an investigational device in the United States. In August 2001, Cordis completed enrollment in its large-scale, clinical trial (SIRIUS), involving 1,101 patients and 53 U.S. hospitals.
Cordis' clinical research program in drug-eluting stents involves 18 separate studies, making it the most extensive drug-eluting stent research program in the industry. To date, nearly 1,600 patients have been enrolled in CYPHER™ Sirolimus-eluting Stent clinical studies. More than 1,000 of the 1,600 have received the CYPHER™ Stent.
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 1994, Johnson & Johnson Interventional Systems Co. pioneered the coronary artery stent. In 1996, Cordis Corporation merged with Johnson & Johnson Interventional Systems Co. to form Cordis Corporation, a Johnson & Johnson company, with approximately 5,300 employees worldwide.
Note: The CYPHER™ Sirolimus-eluting Stent is an investigational device limited by federal (U.S.) law to investigational use.
* RAVEL: RAndomized study with the Sirolimus-eluting VELocity Balloon Expandable Stent.
** Rapamune is a trademark of Wyeth Pharmaceuticals.
Source: Cordis Corporation |
