The FilterWire EZ™ Embolic Protection System is meant to provide ease of use to make this system ideal for carotid artery stenting. With clinically proven safety. Carotid Artery Revascularization Using the Boston Scientific EPI Filter Wire EZ™ and the EndoTex™ NexStent™ (CABERNET). for Recall, Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ” Embolic Protection System. Boston Scientific has determined.

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The Company plans to launch the product in the United States immediately.

Carotid embolic protection system – FilterWire EZ™ – Boston Scientific

The tendency to treat patients at later stages of disease progression almost always means very long lesions and little, if any, flow below the knee. The cold is believed to have several beneficial vascular effects as it opens the artery, including weakening the plaque to allow it filteriwre reshape more easily, reducing vessel elasticity to minimize reclosing of the vessel, and minimizing inflammation and scar tissue formation. Like what you are reading? The company has worked closely with the FDA, medical societies and leading practitioners to develop targeted training programs for physicians based on experience and skill level with carotid artery stent procedures.

The investigators reported that 1, of the 1, enrolled patients were evaluable for day MAE rate. The dominant contributing factors affecting the ability to keep the lower extremity arteries open over time is the length of the vessel that is affected as well as whether filtwrwire not the vessels below the knee have adequate flow.

During a CryoPlasty procedure, a catheter advances a balloon to the site of the occlusion and nitrous oxide, rather than saline, is used to inflate the balloon. These studies will provide for the collection of data on the Acculink Carotid Stent System and the Accunet Embolic Protection System when used by a broad group of physicians.



Craig McChesney cmcchesney bmctoday. Get the latest articles from Med Device Online delivered to your filerwire. Our Editorial Advisory Board is composed of the top endovascular specialists, including interventional cardiologists, interventional radiologists, vascular surgeons, neurologists, and vascular medicine practitioners, and our publication is read by an audience of more than 22, members of the endovascular community.

A prospective, multi-center study Below the Knee Chill is also being initiated at 30 hospitals across the country, evaluating the role of the CryoPlasty technology in avoiding major amputation in patients with severe disease. SVG disease occurs in patients who have previously had coronary artery bypass graft Filyerwire surgery in which a vessel harvested from the patient’s leg is surgically attached to the arteries of the heart. Sign up for our free newsletter. Subscribe I agree to the Terms and Privacy Statement.

Since most of these patients suffer from systemic vascular disease, preserving the conduit vessels for use in the heart is critical. Boston Scientific launched the product in Europe and other international markets in September Without an effective means to open these small, delicate vessels, many patients ultimately require bypass.

CAS with the carotid Wallstent and FilterWire EZ system yielded a low day MAE rate that did not differ significantly across operator experience folterwire training levels, concluded the investigators in Catheterization and Cardiovascular Interventions. Study centers were grouped into three tiers based on previous CAS experience, and individual operators were grouped by their CAS training.

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Additionally, many of these patients have poor overall health and are no longer suitable candidates for a surgical procedure. Since the launch of the PolarCath System inphysicians using the CryoPlasty procedure as a primary therapy have observed a significant reduction in their use of stents, coinciding with a lower rate of flow-limiting dissection and vessel recoil.


Until this is available, your continued use of this site will be deemed as consent to use of cookies. It may be possible to delay progression of the disease to the limb threatening stage.

The new devices will provide a minimally invasive treatment alternative to conventional open carotid artery surgery to patients who are at high surgical risk. News May 26, F with a balloon filled with nitrous oxide.

The nitrous oxide changes into gas upon entering the balloon, cooling it to ? Guidant’s post-approval studies will include at least 1, patients.

Boston Scientific Launches Expanded Size Range Of Embolic Protection System

The infrapopliteal catheters are used with CryoVascular’s PolarCath System, a peripheral CryoPlasty system that treats stenosis by dilating and cooling arteries to ? The Company said the product would be available immediately. The complex nature and progression of SVG disease as compared to native coronary artery disease can create a challenging treatment situation for physicians and a higher risk for patients.

The study also resulted in no deaths, no target lesion revascularizations re-interventions and no sub- acute thrombosis clots during the day follow-up period.

We use cookies to offer a better user experience and to analyze site traffic. Use of Liquid Embolic Agents. Previously, CMS only covered carotid artery stenting in clinical trials of investigational products not yet approved by the FDA.

Enrollment began in Septemberand preliminary results are expected to be presented in early For advertising rates and opportunities, contact: Company Profile Email Us.

The FilterWire EZ System is a low-profile embolic filter mounted on a guide wire and is designed to reduce complications during balloon angioplasty and stenting procedures for the treatment of SVG disease.

Boston Scientific Corporation has received k clearance from the U.