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Better clinical care may contribute to fewer carotid artery surgeries
A nationwide study that reviewed 16 years of Medicare beneficiary data showed a steady reduction in carotid endarterectomy. (Source: Yale Science and Health News)
Source: Yale Science and Health News - September 20, 2017 Category: Universities & Medical Training Source Type: news

Gecko Biomedical wins CE Mark for Setalum vascular sealant
Gecko Biomedical said today it won CE Mark approval in the European Union for its Setalum Sealant designed for use during vascular surgery. The Paris-based company said Setalum is a biocompatible, bioresorbable sealant designed as an add-on to sutures, and is usable in wet and dynamic environments and activated using a light activation pen. The CE Mark approval marks the 1st regulatory win for Gecko Biomedical’s Setalum, the company said. “We are delighted to receive the CE Mark for our 1st product, Setalum sealant, as this will allow us to bring new and innovative solutions to the market to improve patient car...
Source: Mass Device - September 11, 2017 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance Surgical Vascular Gecko Biomedical Source Type: news

FDA updates on Baxter Vascu-Guard patch recall
The FDA today released an update on Baxter‘s (NYSE:BAX) voluntary recall of its Vascu-Guard peripheral vascular patch, saying that it is working with the company but that neither group has discovered a root cause for the issues, which led to a number of adverse events and 3 potential patient deaths. The Vascu-Guard patch is designed for use in vascular reconstruction surgeries including carotid, renal, iliac, femoral, profund and tibial blood vessels and arteriovenous access revisions, the FDA said. While the federal watchdog said it has yet to discover the cause of the issue, it did offer that so far, there have bee...
Source: Mass Device - July 6, 2017 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Recalls Vascular Baxter Source Type: news

Silk Road touts low stroke rate in 2 studies of Enroute TCAR system
Silk Road Medical yesterday released data from 2 studies of its Enroute transcarotid neuroprotection and stent system, including 1-year data from a pivotal trial of the device and an interim analysis of a post-approval study of the Enroute. Data from the studies was presented last month at the 44th annual Veith Symposium in New York. The Sunnyvale, Calif.-based company touts the Enroute system and stent as the 1st and only devices currently approved for transcarotid artery revascularization procedures by the FDA. Silk Road presented data from the Roadster 1 pivotal trial of the TCAR system, wh...
Source: Mass Device - December 13, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Vascular Silk Road Medical Inc. Source Type: news

Baxter recalls select IV fluid filters
Baxter (NYSE:BAX) is recalling its 50mm 0.2 micron filter used to filter water-based intravenous solutions due to the presence of particulate mater and the potential absence of filter layers. The FDA has labeled the recall as Class 1, indicating “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency. The recalled devices are designed for use in hospital pharmacies to filter bacteria and other microscopic matter during the preparation of water-based solutions used for IV administration sets. The filter is designed to a...
Source: Mass Device - October 6, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Recalls Regulatory/Compliance Baxter International Source Type: news

Silk Road Medical touts Medicare coverage decision for carotid procedures
Silk Road Medical said yesterday the Centers for Medicare and Medicaid Services granted coverage for transcarotid artery revascularization procedures, including those performed with the company’s Enroute transcarotid neuroprotection and stent system. The TCAR procedures are now eligible for coverage for patients who are treated with FDA-approved proximal embolic protection devices and approved carotid artery stent systems indicated for transcarotid procedures. The devices are also required to be entered into the national TCAR Surveillance Project, Sunnyvale, Calif.-based Silk Road Medical said. The company said it&rs...
Source: Mass Device - September 16, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Stents Vascular Centers for Medicare and Medicaid Services (CMS) Silk Road Medical Inc. Source Type: news

FDA Warns of Adverse Events With Vascu-Guard in CEA FDA Warns of Adverse Events With Vascu-Guard in CEA
The agency has received several reports of severe postoperative bleeding and hematomas possibly linked to the peripheral vascular patch during carotid endarterectomy.News Alerts (Source: Medscape Neurology and Neurosurgery Headlines)
Source: Medscape Neurology and Neurosurgery Headlines - September 1, 2016 Category: Neurology Tags: Neurology & Neurosurgery News Alert Source Type: news

Deaths prompt FDA warning on Baxter ’ s Vascu-Guard patch
The FDA today released a notice warning of issues with Baxter‘s (NYSE:BAX) Vascu-Guard peripheral vascular patch after receiving multiple adverse event reports including 3 patient deaths potentially related to the issue. The Vascu-Guard patch is designed for use in vascular reconstruction surgeries including carotid, renal, iliac, femoral, profund and tibial blood vessels and arteriovenous access revisions, the FDA said. The federal watchdog said it has received reports of issues with intraoperative or postoperative bleeding and hematomas, some of which required clinical interventions and 3 patient deaths which occur...
Source: Mass Device - September 1, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Recalls Vascular Baxter International Source Type: news

Potential Risk of Severe Bleeding and Hematomas Associated with VASCU-GUARD Peripheral Vascular Patch – Letter to Health Care Providers
The FDA has recently received multiple adverse event reports associated with Baxter International Inc. ’s Vascu-Guard Peripheral Vascular Patch (also referred to as the Vascu-Guard patch) during carotid endarterectomy (CEA). (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 1, 2016 Category: Medical Equipment Source Type: news

Carotid Endarterectomy May Be Risky in Hemodialysis PatientsCarotid Endarterectomy May Be Risky in Hemodialysis Patients
The risks of carotid endarterectomy (CEA) in hemodialysis patients are high and may outweigh the benefits in some, according to a large observational study by Baltimore-based researchers. Reuters Health Information (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - July 7, 2016 Category: Surgery Tags: Nephrology News Source Type: news

Silk Road touts TCAR study data
Silk Road Medical disclosed encouraging new clinical data for its Enroute device, which is cleared to help protect the brain from stroke while implanting a transcarotid artery stent. The company said that additional data showed its Enroute transcarotid neuroprotection and stent system, indicated for transcarotid artery revascularization (TCAR), helped improve stroke and death rates in the wake of its FDA sign-off last October. Investigators from Massachusetts General Hospital and elsewhere presented their findings during the 2016 Vascular Annual Meeting of the Society for Vascular Surgery, which was held June 8-11 in Natio...
Source: Mass Device - June 15, 2016 Category: Medical Equipment Authors: Mark Hollmer Tags: Catheters Clinical Trials Stents Vascular Silk Road Medical Inc. Source Type: news

Controversies in Psychiatry: Psychiatric Times & Neurology Times
(MedPage Today) -- Also, carotid endarterectomy or stenting? (Source: MedPage Today Psychiatry)
Source: MedPage Today Psychiatry - June 1, 2016 Category: Psychiatry Source Type: news

Carotid stenting noninferior to surgery for asymptomatic patients
The findings of the ACT 1 trial suggest that carotid artery stenting is just as effective as carotid endarterectomy in patients with asymptomatic stenosis. (Source: MedWire News)
Source: MedWire News - February 19, 2016 Category: Consumer Health News Tags: Stroke Source Type: news

CREST: Stenting and Endarterectomy Similarly Effective After 10 Years' Follow-Up (FREE)
By Amy Orciari Herman Edited by Jaye Elizabeth Hefner, MD, and William E. Chavey, MD, MS Carotid endarterectomy and stenting yield similar long-term results, according to 10-year follow-up data from CREST, an industry-funded trial published in the New England Journal … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - February 19, 2016 Category: Primary Care Source Type: news

Stroke Rounds: Heparin Reversal Following CEA Safe (CME/CE)
(MedPage Today) -- Meta-analysis: stroke risk was not increased in carotid endarterectomy (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - October 22, 2015 Category: Cardiology Source Type: news

Asymptomatic Carotid Disease and the Fallacy of Preventive SurgeryAsymptomatic Carotid Disease and the Fallacy of Preventive Surgery
The "see lesion, stent lesion" approach to cardiology has been discredited. Dr Mandrola sees a parallel in the overuse of carotid endarterectomy and stenting in asymptomatic patients. theheart.org on Medscape (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - September 30, 2015 Category: Cardiology Tags: Cardiology Expert Column Source Type: news

Stroke Reduction Key for Dual Antiplatelet Therapy in CEA
CHICAGO — Researchers advised against automatically discontinuing dual antiplatelet therapy for carotid endarterectomy (CEA) because the neuroprotective effects may outweigh the bleeding risks, in a review of more than 28,000 patients who underwent the procedure during 2003–2014. (Source: Caring for the Ages)
Source: Caring for the Ages - September 29, 2015 Category: Health Management Authors: M. Alexander Otto Source Type: news

Medtech approvals: FDA releases May 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in May 2015: Summary of PMA Originals & Supplements Approved Originals: 5 Supplements: 51 Summary of PMA Originals Under Review Total Under Review: 55 Total Active: 26 Total On Hold: 29 Summary of PMA Supplements Under Review Total Under Review: 547 Total Active: 379 Total On Hold: 168 Summary of All PMA Submissions Originals: 1 Supplements: 62 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 51 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 109.5 FDA Time: 86...
Source: Mass Device - August 6, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

Stroke Rounds: Early Surgery Looks Safe After tPA
(MedPage Today) -- Performing carotid endarterectomy or stenting in patients who were recently treated with thrombolytic therapy for an acute stroke appeared to be safe, an observational study showed. (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - March 11, 2014 Category: Cardiology Source Type: news

Staged CABG After Endarterectomy Minimizes Risk of MI, StrokeStaged CABG After Endarterectomy Minimizes Risk of MI, Stroke
Coronary artery bypass grafting (CABG) within 24 hours after carotid endarterectomy (CEA) reduces the risk of myocardial infarction and stroke. Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - March 6, 2014 Category: Consumer Health News Tags: Neurology & Neurosurgery News Source Type: news

Carotid Stenting Associated with Stroke in Elderly, Meta-Analysis Finds (FREE)
By Joe Elia The elderly seem to fare better with carotid endarterectomy than with stenting, according to a JAMA Surgery meta-analysis.Researchers examined outcomes from over 40 … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - October 24, 2013 Category: Primary Care Source Type: news

Surgery Preferable To Stents In Elderly People With Carotid Disease
Age should play an important role in choosing a revascularization procedure for people with blocked carotid arteries, according to a new paper published in JAMA Surgery.  Carotid endarterectomy surgery (CEA) is preferable to carotid artery stenting (CAS) in elderly people; for younger patients the two revascularization procedures are broadly similar. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - October 23, 2013 Category: Pharmaceuticals Authors: Larry Husten Source Type: news

Stenting Carotid Arteries Risky for Seniors (CME/CE)
(MedPage Today) -- Carotid endarterectomy and carotid stenting to treat carotid disease worked equally well in younger patients, but in elderly patients endarterectomy was associated with a lower risk of stroke, a meta-analysis showed. (Source: MedPage Today State Required CME)
Source: MedPage Today State Required CME - October 23, 2013 Category: Consumer Health News Source Type: news

Carotid artery stenting appears associated with increased stroke in elderly
Carotid artery stenting (CAS) was associated with an increased risk of stroke in elderly patients but the mortality risk appeared to be the same as for nonelderly patients, according to a review of the medical literature published Online First by JAMA Surgery, a JAMA Network publication. There is debate about the most appropriate treatment for carotid artery atherosclerosis and about the safety of CAS (using a stent to expand the carotid artery) and CEA (carotid endarterectomy, a procedure to remove plaque from the artery) in elderly patients, according to the study background... (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - October 23, 2013 Category: Consumer Health News Tags: Medical Devices / Diagnostics Source Type: news

Revised Article-Carotid Endarterectomy
Carotid endarterectomy, or CEA, is a type of surgery that is used to prevent strokes in people who have carotid artery disease. (Source: National Heart, Lung, and Blood Institute Health Topics)
Source: National Heart, Lung, and Blood Institute Health Topics - January 7, 2011 Category: Consumer Health News Source Type: news