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 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. Research presented at the Annual Transcatheter Cardiovascular Therapeutics Scientific Symposium TCTshowed outcomes of the first patients to receive the therapy.

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. We use cookies to offer a better user experience and to analyze site traffic. Get the latest vascular news sent to your inbox. CAS with the carotid Wallstent and FilterWire EZ system yielded a low day MAE rate that did not differ significantly across operator experience and training levels, concluded the investigators in Catheterization and Cardiovascular Interventions.

CABANA Data Published for Boston Scientific’s Carotid Wallstent With FilterWire EZ System

Company Profile Email Us. Additionally, many of these patients have poor overall health and are no longer suitable candidates for a surgical procedure. Five patients 25 percent underwent toe or transmetatarsal amputation of pre-existing gangrene and 1 patient who was treated for bilateral disease underwent subsequent bypass surgery in one limb.

Since most of these patients suffer from systemic vascular disease, preserving the conduit vessels for use in dz heart is critical. Since the launch of the PolarCath System inphysicians using the CryoPlasty procedure as a primary therapy have filterwirr a significant reduction in their use of stents, coinciding with a lower rate of flow-limiting dissection and vessel recoil.

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

Boston Scientific Launches Expanded Size Range Of Embolic Protection System

Study centers were grouped into three tiers based on previous CAS experience, and individual operators were grouped by their CAS training. Guidant’s post-approval studies will include at least 1, patients. Charles Philip cphillip bmctoday. I agree to the Terms and Privacy Statement.


The background of the study is that there is a need for additional evidence evaluating carotid artery stenting CAS performed by operators with various experience and training levels, stated the investigators.

The primary endpoint was the day composite of major adverse events MAEincluding stroke, death, and myocardial infarction MI. News May 26, Boston Scientific launched the product in Europe and other international markets in Filtefwire Get the latest articles from Med Device Online delivered to your inbox.

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 tendency to treat patients at later stages of disease progression almost always means very long lesions and little, if any, flow below the knee.

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. 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.

SVG disease occurs in patients who have previously had coronary artery bypass graft CABG surgery in which a vessel harvested from the patient’s leg is surgically attached to the arteries of the heart. Boston Scientific Corporation has received k clearance from the U. The cold is believed to have several beneficial vascular effects as it opens the artery, including weakening the plaque to allow it to reshape more easily, reducing vessel elasticity to minimize reclosing of the vessel, and minimizing inflammation and scar tissue formation.

For advertising rates and opportunities, contact: Sign up for our free newsletter. Limb salvage with freedom from major amputation was achieved in 19 patients 95 percent and only 1 patient 5 percent proceeded to below-the-knee amputation.

Blood is redirected through the surgically attached SVG, bypassing the blocked artery and increasing blood flow to the heart. Individual event rates were evaluated across the overall study, and by center experience and physician filterwier tier.


FILTERWIRE EZ™ Embolic Protection System for SVGs – Boston Scientific

Ninety-five percent of the patients were able to avoid almost-certain amputation below the knee as a result of treatment with the Fjlterwire System Infrapopliteal Catheter. 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. 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 or not the vessels below the knee have adequate flow.

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 filteerwire Like filterwiee you are reading? The Company plans to launch the product in the United States immediately.

Subscribe I agree to the Terms and Privacy Statement. Endovascular Today is a publication dedicated to bringing you comprehensive coverage filterwure all the latest technology, techniques, and developments in the endovascular field. About Endovascular Today Endovascular Today is a publication dedicated to bringing you comprehensive coverage filtrwire all the latest technology, techniques, and developments in the endovascular field.

The infrapopliteal catheters are used with CryoVascular’s PolarCath System, a peripheral CryoPlasty system that treats stenosis by dilating and cooling arteries to ?

Embolic protection: the FilterWire EZ Embolic Protection System.

Next-generation system cleared for SVG treatment in the U. Contact Info For advertising rates and opportunities, contact: Stephen Hoerst shoerst bmctoday. 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.

The investigators reported that 1, of the 1, enrolled patients were evaluable for day MAE rate. The stroke rate of 3.