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Specialty: Medical Devices
Procedure: Carotid Endarterectomy
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Total 14 results found since Jan 2013.
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, which examined the use of ...
Source: Mass Device - December 13, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Vascular Silk Road Medical Inc. Source Type: news
InspireMD touts results of next-gen stroke prevention stent study
InspireMD (NYSE:NSPR) has released the results of a meta-analysis of four clinical studies involving dual-layered (DLS) and mesh-covered stents, including the company’s MicroNet-covered stent, the CGuard embolic prevention system.
The analysis concluded that carotid artery disease patients treated with mesh-covered stents experienced a 30-day minor stroke rate of 1.25%, lower than the 30-day minor stroke rates reported in other widely cited studies, such as CREST and ACT 1, for patients treated with both carotid endarterectomy and with those treated with conventional carotid stents. CREST and ACT 1 also involved lower...
Source: Mass Device - December 24, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Cardiovascular Research & Development Stents InspireMD Terumo 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
Silk Road Medical touts TCAR study data
Silk Road Medical today released results from studies of its transcarotid artery revascularization procedure, touting favorable outcomes in treating patients with carotid artery disease.
Data from the studies were presented at the Society for Vascular Surgery 2018 Vascular Annual Meeting in Boston.
The transcarotid artery revascularization procedure uses the Sunnyvale, Calif.-based company’s Enroute transcarotid stent and neuroprotection system, and is intended to treat blockages in the carotid artery that are at risk of causing a stroke.
Results from a two-year study which compared outcomes from 1,182 patients who r...
Source: Mass Device - June 29, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular Silk Road Medical Inc. Source Type: news
UPDATE: Silk Road Medical prices $120m IPO
Updated to include comment from CEO Erica Rogers
Silk Road Medical late yesterday priced its initial public offering, looking to raise approximately $120 million.
The Sunnyvale, Calif.-based company said it plans to float 6 million shares of its common stock at a price of $20 per share. The offering also includes a 30-day underwriters option to purchase an additional 900,000 shares of common stock.
Silk Road Medical produces the Enroute transcarotid neuroprotection and stent system, which is intended for use during the transcarotid artery revascularization procedure, or TCAR.
“The Enroute system is part of the devic...
Source: Mass Device - April 4, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Vascular Wall Street Beat Silk Road Medical Inc. 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
Procedural embolic protection strategies for carotid artery stenting: current status and future prospects
Expert Rev Med Devices. 2023 Mar 31. doi: 10.1080/17434440.2023.2198124. Online ahead of print.ABSTRACTINTRODUCTION: Carotid artery angioplasty and stenting (CAS) is an established procedure to treat carotid artery stenosis for either primary or secondary prevention of stroke. Randomized clinical trials have shown an increased risk of periprocedural cerebrovascular events with CAS compared with carotid endarterectomy (CEA). Several strategies have been proposed to mitigate this risk, including alternative vascular access site, proximal/distal embolic protection devices, and dual layer stents among others.AREAS COVERED: Thi...
Source: Expert Review of Medical Devices - March 31, 2023 Category: Medical Devices Authors: Eligio Miccich è Francesco Condello Davide Cao Alessia Azzano Anna Maria Ioppolo Andrea Mangiameli Alberto Cremonesi Source Type: research
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...
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 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
Russian study pits InspireMD ’ s CGuard device against Abbott ’ s Rx Acculink carotid stent
InspireMD (NYSE:NSPR) this week touted an independent clinical trial in Russia pitting its CGuard embolic protection device against the Rx Acculink carotid stent made by Abbott (NYSE:ABT).
The 100-patient trial is designed to compare the two devices in terms of neuroprotection and clinical superiority in subjects undergoing carotid endarterectomy, the Tel Aviv-based company said. Conducted at the Scientific Research Institute of Circulation Pathology in Novosibirsk, the study is led by Dr. Andrei Karpenko.
The primary endpoint is new ischemic areas in the brain 24 to 48 hours post-procedure and new lesion permanence at...
Source: Mass Device - October 12, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Stents InspireMD Stroke Source Type: news
InspireMD inks distro deal for CGuard in South Africa
InspireMD (NYSE:NSPR) said today that it inked a deal with Torque Medical to distribute its CGuard Embolic Prevention System in South Africa.
The Israel-based company reported that it will begin the commercial launch for CGuard in South Africa immediately.
“We are extremely pleased with the opportunity to offer CGuard EPS in the South African market. We were approached by some of our key customers in the Vascular Surgery, Interventional Neurology and Interventional Cardiology field who had learned about CGuard EPS through conferences and publications and wanted us to make it available in South Africa,” Craig G...
Source: Mass Device - January 14, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Distribution Featured Vascular Wall Street Beat InspireMD Source Type: news
