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 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. Craig McChesney cmcchesney bmctoday.

Carotid embolic protection system – FilterWire EZ™ – Boston Scientific

The nitrous oxide changes into gas upon entering the balloon, cooling it to ? The FilterWire EZ system is designed to enhance the effectiveness and ease of use of the product. We use cookies to offer a better user experience and to analyze site traffic. Previously, CMS only covered carotid artery stenting in clinical trials of investigational products not yet approved by the FDA.

Get the latest articles from Med Device Online delivered to your inbox. 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. Additionally, many of these patients have poor overall health and are no longer suitable candidates for a surgical procedure. Until this is available, your continued use of this site will be deemed as consent to use of cookies.

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. Contact Info For advertising rates and opportunities, contact: Ninety-five percent of the patients were able to avoid almost-certain amputation below the knee as a result of treatment with the PolarCath System Infrapopliteal Catheter.


Boston Scientific Corporation has received k clearance from the U. 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.

The system is also 6F guide catheter compatible, and has enhanced deliverability with a 3. The stroke rate of 3.

By introducing this smaller size, Boston Scientific now makes it possible for physicians to meet this standard of care in a broader range of SVG vessels.

For advertising rates and opportunities, contact: The company has worked closely with the FDA, medical societies and leading practitioners to develop targeted filterdire programs for physicians based on experience and skill level with carotid artery stent procedures. Get the latest vascular news sent to your inbox. The dominant contributing factors affecting the ability to keep the lower extremity arteries filteerwire 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.

A prospective, multi-center study Below the Knee Chill is filterire being initiated at 30 hospitals across the country, evaluating the role of the CryoPlasty technology in fiterwire major amputation in patients with severe disease. About Endovascular Today Endovascular Today is a publication dedicated to bringing you comprehensive coverage of all the latest technology, techniques, and developments in the endovascular field.

All 20 patients received the CryoPlasty technique using the PolarCath System Infrapopliteal Catheter as the primary therapy; 6 patients with severely blocked vessels underwent atherectomy to create a channel that would allow passage of the catheter.

Boston Scientific Launches Expanded Size Range Of Embolic Protection System

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. Sign up for our free newsletter. Since most of these patients suffer from systemic vascular disease, preserving the conduit vessels for use in the heart is critical.


Endovascular Today is a publication dedicated to bringing you comprehensive coverage of all the latest rilterwire, techniques, and developments in the endovascular field. Individual event rates were evaluated across the overall study, and by center experience and physician training tier.

I agree to the Terms and Privacy Statement. Guidant’s post-approval studies will include at least 1, patients.

Study centers were grouped into three ezz based on previous CAS experience, and individual operators were grouped by their CAS training. The new devices will provide a minimally invasive treatment alternative to conventional open carotid artery surgery to patients who are at high surgical risk.

Limb salvage with freedom from major amputation was achieved in 19 patients 95 percent and only 1 patient 5 percent filterrwire to below-the-knee amputation. 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. F with a balloon filled with nitrous oxide.

Since the launch of the PolarCath System inphysicians using the CryoPlasty filtedwire 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. Without an effective means to open these small, delicate vessels, many patients ultimately require bypass. The investigators reported that 1, of the 1, enrolled patients were evaluable for day MAE rate.

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

It may be possible to delay progression of the disease to the limb threatening stage. Is There a Role for Endovascular Reconstruction…. Blood is redirected through the surgically attached SVG, bypassing the blocked artery and increasing blood flow to the heart. Research presented at the Annual Transcatheter Cardiovascular Eez Scientific Symposium TCTshowed outcomes of the first patients to receive the therapy.