PVD-SMART-CORDIS

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Muralidhar R

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Sep 18, 2008, 11:46:53 AM9/18/08

to Invasive CVTs

PVD Treatment Milestone Announced At Cardiovascular And Interventional Radiology Society Of Europe (CIRSE)

Cordis Corporation, a leader in peripheral vascular disease (PVD) clinical research and treatment options, announced during the annual Cardiovascular and Interventional Radiology Society of Europe (CIRSE) Congress the placement of the one-millionth Cordis S.M.A.R.T.(R) Nitinol Self-Expandable Stent System.

Professor Dierk Scheinert, M.D., Department of Medicine, Angiology and Cardiology, University of Leipzig Heart Center said, "I've been using the S.M.A.R.T(R). Stent for the past 10 years and believe its success is due to the radial strength and flexibility to provide good scaffolding which reduces the risk of clinical lesions. Cordis decided early on to study this device in clinical trials and to provide long-term data on stent durability and stent patency."

Asked to comment on the evolution of PVD treatment options and specifically, superficial femoral artery (SFA) disease, Professor Scheinert said, "Well, if you ask me about the changes and the perception of SFA stenting in Europe over the past ten years I must say that Cordis really made significant progress. I recall that ten years ago we only had very first generation devices - balloon-expandable stents that were not really suitable to fulfill the requirements in the SFA location. And it was probably the S.M.A.R.T.(R) Stent that was one of the first that changed this SFA stenting story quite a bit. It's a device which is easy to deploy and was relatively early studied also in clinical trials and I think the results obtained with this device helped a lot to establish stenting as a first line option or an option at least to help improve results of interventional treatment in the SFA."

The SFA is the longest artery in the human body and revascularization (restoration of blood flow) is one of the most commonly performed endovascular procedures today. SFA disease is commonly associated with PVD and atherosclerosis, a buildup of fatty deposits, or plaque, and leads to hardening and narrowing of the arteries, most often in the legs. It remains significantly under -diagnosed and leads to increased mortality and morbidity as well as lifestyle and fitness impairment.

Summarizing his clinical experience over a decade, Professor Scheinert concluded, "I would say to Cordis, having just implanted the one-millionth S.M.A.R.T.(R) stent, continue to support clinical trials to test new interventional techniques and provide a solid database to draw conclusions and build upon our clinical strategies." Cordis continues to study and advance the treatment of SFA disease through two ongoing clinical trials: SUPER SL in Germany and SUPER UK in the UK.

The S.M.A.R.T.(R) Stent is the most investigated self-expanding SFA Nitinol stent available. The body of clinical evidence includes two landmark studies: The SIROCCO trial, which provided robust, long-term evidence on SFA stenting and the longest follow-up period for any randomised study in the SFA; and the Leipzig four-year S.M.A.R.T.(R) Registry which studied complex femoropopliteal lesions. The S.M.A.R.T.(R) Stent demonstrated favorable primary and secondary patency rates in shorter lesions.

Self-expanding stents are made of a unique Nickel Titanium alloy called Nitinol that expands when heated and remain in the vessel without support from a balloon.