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.

Author: Kalkis Vijar
Country: Republic of Macedonia
Language: English (Spanish)
Genre: Art
Published (Last): 9 July 2014
Pages: 242
PDF File Size: 5.90 Mb
ePub File Size: 18.37 Mb
ISBN: 169-9-19119-419-5
Downloads: 80700
Price: Free* [*Free Regsitration Required]
Uploader: Mukasa

Enrollment began in Septemberand preliminary results are expected to be presented in early We use cookies to offer a better user experience and to analyze site traffic. Until this is available, your continued use of this site will be deemed as consent to use of cookies. 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.

Limb salvage with freedom from major amputation was achieved in 19 filtefwire 95 percent and only 1 patient 5 percent proceeded to below-the-knee amputation.

Boston Scientific Launches Expanded Size Range Of Embolic Protection System

Previously, CMS only covered carotid artery stenting in clinical trials of investigational products not yet approved by the FDA. During a CryoPlasty procedure, a catheter advances a balloon to the site of the occlusion and nitrous oxide, rather filterwirs saline, is used to inflate the balloon. Is There a Role for Endovascular Reconstruction….

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.

Sign up for our free newsletter. Boston Scientific Corporation has received k clearance from the U.

FILTERWIRE EZ™ Embolic Protection System for SVGs – Boston Scientific

The system is also 6F guide catheter compatible, and has enhanced deliverability with a 3. For advertising rates and opportunities, contact: The investigators reported that 1, of the 1, enrolled patients were evaluable for day MAE rate. The FilterWire EZ System is a low-profile embolic protection device that has been clinically proven to capture and remove cilterwire material, leading to reduced complications during balloon angioplasty and stenting procedures in SVGs 2.


Without an effective means to open these small, delicate vessels, many patients ultimately require bypass. Study centers were grouped into three tiers based on previous CAS experience, and individual operators were grouped by filteerwire CAS training. Five patients 25 percent underwent toe or transmetatarsal amputation of pre-existing gangrene and 1 patient who was treated for bilateral disease underwent ffilterwire bypass surgery in one limb.

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. The primary endpoint was the day composite of major adverse events MAEincluding stroke, death, and myocardial infarction MI.

Boston Scientific Launches Expanded Size Range Of Embolic Protection System

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. It may be possible to delay progression of the disease to the limb threatening stage. The tendency to treat patients at es stages of disease progression almost always means filteerwire long lesions and little, if any, flow below the knee.

Get the latest articles from Med Device Online delivered to your inbox.

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

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.

The Company said the product would be available immediately. The Company plans to launch the product in the United Filterwirf 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. CAS with the carotid Wallstent and FilterWire EZ system filterwir a low day MAE rate that did not differ significantly across operator experience and training levels, concluded the investigators in Catheterization and Cardiovascular Interventions.

Get the latest vascular news sent to your inbox. Endovascular Today is a publication dedicated to bringing you comprehensive coverage of all the latest technology, techniques, and developments in the endovascular field. Use of Liquid Embolic Agents. The nitrous oxide changes into gas upon entering the balloon, cooling it to ? Our Editorial Advisory Filtewire is composed of the top endovascular specialists, including filterdire 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.


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, filtdrwire vessel elasticity to minimize reclosing of the vessel, and minimizing inflammation and scar tissue formation.

The stroke rate filterwrie 3. Blood is redirected through the surgically attached SVG, bypassing the blocked artery and increasing blood flow to the heart.

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

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. The dominant contributing factors affecting the filterwige 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.

Boston Scientific launched the product in Europe and other international markets in September The FilterWire EZ system is designed to enhance the effectiveness and ease of use of the product. SVG filtterwire occurs in filetrwire 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.

Contact Info For advertising rates and opportunities, contact: Research presented at the Annual Transcatheter Cardiovascular Therapeutics Scientific Symposium TCTshowed outcomes of the first patients to receive the therapy.