European Study Initiated to Compare Sirolimus-eluting Stenting versus Balloon Angioplasty in Patients with Peripheral Artery Disease Below-the-Knee

Cordis Corporation will compare its CYPHER SELECT TM

+ (Plus) Sirolimus-eluting Stent with balloon angioplasty, the company

announced today at the EuroPCR meeting in Barcelona. The multicenter

prospective, randomized ACHILLES study will evaluate the performance of

stenting versus balloon angioplasty in patients with below-the-knee

(infrapopliteal) peripheral artery disease (PAD).
Patients with PAD have plaque buildup in their arteries, limiting proper

flow and delivery of blood and oxygen to different areas of the body.

Ischemic infrapopliteal arterial disease, a type of PAD, limits blood

flow below the knee, causing pain, skin ulcers or sores, and an

increased risk of amputation.
Dierk Scheinert, M.D., Head, Department of Angiology, University of

Leipzig - Heart Center & Park Hospital said, "Peripheral

artery disease is a widespread but often under diagnosed condition in

Europe and around the world. It is important to understand and evaluate

the safety and efficacy of treating patients less invasively with a

drug-eluting stent and angioplasty opposed to angioplasty alone as we

explore potential new treatment options for below-the-knee PAD." Dr. Scheinert, is principal investigator of the ACHILLES study and has

served as a consultant to Cordis Corporation. He conducted the first

procedure when the study was initiated in March at the University of

Leipzig "“ Heart Center & Park Hospital.
The ACHILLES study will be conducted in 17 centers throughout Europe.

Two hundred patients with new (de novo) or restenotic native lesions in

arteries below the knee (i.e., tibioperoneal, anterior, posterior

tibial, or peroneal) will be entered into the study and randomized on a

1:1 basis to receive the CYPHER SELECT TM +

(Plus) Stent or balloon angioplasty, the current endovascular standard

of care. All patients will undergo an X-ray examination of the blood

vessels (angiography) at 12 months to assess the primary study endpoint

of re-narrowing or blockage (in-segment binary restenosis).
"The safety and efficacy of the CYPHER SELECT TM + (Plus) Stent in treating patients with arterial obstructions in

arteries where regulatory approvals have been approved has been proven

through a robust clinical trial program," said

Dennis Donohoe, M.D., Vice President, Worldwide Clinical Affairs, Cordis

Corporation. "We are now eager to evaluate how

this stent may in the future provide physicians and patients with a

minimally invasive treatment option to open below-the-knee arterial

blockages, which can be extremely painful and often lead to limb

amputation."
About the CYPHER SELECT TM Plus Stent
The first next-generation drug-eluting stent, the CYPHER SELECT TM Stent, was launched in Europe, Asia Pacific, Latin America and Canada in

2003. The CYPHER SELECT TM + (Plus) Stent, the

first third-generation drug-eluting stent, received the CE mark in June

2006 and is now available in many markets outside the United States.
About Cordis Corporation
Cordis Corporation, a Johnson & Johnson company, is a worldwide leader

in the development and manufacture of interventional vascular

technology. Through the company´s innovation, research and development

Cordis partners with interventional cardiologists worldwide to treat

millions of patients who suffer from vascular disease.