SIROCCO TRIAL SHOWS MINIMAL RESTENOSIS RATES WITH CORDIS STENT.

Results of the SIROCCO Trial (Sirolimus-Coated Cordis Self-expandable Stent) evaluating the effectiveness of the S.M.A.R.T.(R) nitinol self-expandable stent for the treatment of obstructive superficial femoral artery disease and published recently in the Journal of Endovascular Therapy(1), show that the bare S.M.A.R.T. (R) Stent is as safe and effective as the sirolimus-eluting S.M.A.R.T. (R) Stent(1). Investigators reported that both stents are largely free of restenosis for up to 24 months in the treatment of chronic limb ischemia(1). The SIROCCO Trial is the first international, multicenter, prospective, randomized, double-blind study with angiographic follow-up, assessed by an independent core lab, to evaluate the use of nitinol stents in the superficial femoral artery (SFA).

Currently, treatment of SFA stenosis is among the most challenging of all endovascular procedures in terms of long-term patency(2). "Primary and secondary patency in superficial femoral artery (SFA) occlusions treated with nitinol stents are up to 80% at one year, but restenosis rates are between 40-50% at two years(3). In contrast, the cumulative in-stent restenosis rates according to duplex ultrasound in the SIROCCO Trial were 4.7%, 9.0%, 15.6%, and 21.9%, respectively, at 6, 9, 18, and 24 months for the S.M.A.R.T.(R) Stents; the rates did not differ significantly between the treatment groups.

Prof. Stephan Duda, MD, from the Center for Diagnostic Radiology and Minimally Invasive Therapy, The Jewish Hospital, Berlin, Germany, states "The results of this trial have significant implications for the treatment of chronic limb ischemia and challenging TASC type C lesions in the SFA which are traditionally referred for bypass graft surgery by TransAtlantic Inter-Society Consensus (TASC). This first prospective trial of the long-term effects of the nitinol stents using angiographic follow-up, clearly shows the efficacy of minimally invasive endovascular treatment with self-expanding nitinol S.M.A.R.T. (R) Stents."

Dr. Dierk Scheinert from Leipzig Heart Center, Germany, states "The Cordis S.M.A.R.T(R) Stent, which is also the most investigated peripheral nitinol stent, offers the flexibility and ability to recover from crushing required at this site and has a promising track record in this indication. The 24-month results from the SIROCCO study have once again proven that stent design plays a key role in long-term results."

The SIROCCO study included 93 patients in two treatment arms: 47 patients received the sirolimus-eluting S.M.A.R.T. (R) stent and 46 patients received a bare self-expanding S.M.A.R.T. (R) nitinol stent(1). The binary in-stent restenosis rates (22.9 per cent sirolimus-eluting, 21.1 per cent bare self-expanding nitinol S.M.A.R.T. (R) Stent) were much lower than previously reported, and did not show any significant difference between stents for up to 24 months(1). Stent fractures were detected up to 18 months in eight patients in the bare stent group and nine in the sirolimus-eluting stent group. One additional patient was found to have a stent fracture at 24-month follow-up. All patients were clinically asymptomatic.

Dr. Dennis Donohoe, Worldwide Vice President, Clinical and Regulatory Affairs, Cordis Corporation, said "This landmark trial provides robust, long-term evidence on SFA stenting, seen by objective, independent analysis. SIROCCO tells us that the bare S.M.A.R.T. (R) Stent is effective in the treatment of SFA obstructions. The equivalent performance of the first-generation sirolimus-eluting S.M.A.R.T. (R) Stent shows that additional research and development must be performed to properly optimize the sirolimus-elution parameters for this challenging vessel."

"Peripheral arterial disease (PAD), including SFA disease, results in a narrowing of the peripheral arteries caused by the build-up of plaque. Prevalence of PAD is estimated to increase to 23 million by 2014, as the population ages. Current treatment options include disease management through lifestyle changes and medication, minimally invasive percutaneous transluminal angioplasty (PTA) and stenting or major surgery such as bypass grafts. PTA has lower morbidity, quicker recovery and reduced hospital stay compared with major surgery; however re-occlusion may occur within 6 to 24 months of treatment. The first-generation sirolimus-eluting S.M.A.R.T. (R) Stent was designed to reduce in-stent restenosis, which remains the major limitation with this procedure. Sirolimus is an immunosuppressant agent that inhibits the proliferation of vascular smooth-muscle cells."

Cordis is committed to advancing the treatment of SFA diseases due to PAD and is thus conducting several multi-center, randomized studies across Europe. The SUPER SL study in Germany compares the performance of the Cordis S.M.A.R.T.(R) stent and the Bard(R) Luminexx(TM) stent in SFA. This study aims at evaluating primary patency (defined as presence of flow through the index lesion) is targeting lesions up to 22 centimetres, which are classed as 'C' and 'D' lesions by the TASC and are traditionally referred for bypass graft surgery.

The SUPER (UK), Duravest (Netherlands) and SIT-UP (Switzerland) studies will compare stenting with S.M.A.R.T Stent versus PTA targeting lesions up to 14.5 cm in patients with symptomatic peripheral vascular disease with SFA stenosis/occlusions due to PAD. Patients will be followed for 12 months post procedure and the primary endpoint is primary patency at one year demonstrated by ultrasound.

About Cordis Endovascular

Cordis Endovascular is a recognized leader in endovascular research and development. It has the resources to make breakthrough treatments possible along with the reputation for delivering trusted, quality products and value that is expected by our customers.

Cordis Endovascular is a worldwide supplier of interventional and diagnostic medical products including nitinol and stainless steel stents, vena cava filters, balloon catheters and accessories. It is committed to serving the cardiology, radiology and vascular surgery communities through the development of groundbreaking technologies for the treatment of peripheral vascular disease.

Cordis Endovascular constantly seeks solutions to the human anatomy's most challenging problems, such as carotid artery disease, aortic aneurysm, superficial femoral artery disease and venous thrombotic disease.

About Cordis Corporation

Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in developing and manufacturing interventional vascular technology. Through the company's innovation, research and development, physicians worldwide are better able to treat the millions of patients who suffer from vascular disease.

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