Medtronic Receives First FDA Approval of Cobalt Chromium …
The Assurant Cobalt stent leverages the strength of cobalt chromium and a unique modular design to create a device with ultrathin, round, edgeless struts, allowing …
The Assurant Cobalt stent leverages the strength of cobalt chromium and a unique modular design to create a device with ultrathin, round, edgeless struts, allowing …
Purpose: To report the outcome of the ACTIVE (Use of the Assurant Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) study (ClinicalTrials.gov Identifier: NCT00753337), which was designed to determine the safety and effectiveness of the next-generation Assurant cobalt chromium balloon-expandable stent in symptomatic …
The Assurant Cobalt® Balloon Expandable Stent System is designed to treat restenosis in the iliac artery by opening clogged arteries and restoring blood flow. The stent provides …
Medtronic has received US Food and Drug Administration (FDA) clearance for its Assurant cobalt iliac balloon-expandable stent system, designed to treat narrowed iliac arteries. The approval is supported by the nine-month results from a trial that demonstrated technical, procedural and clinical success with the use of the Assurant stent.
The Assurant Cobalt® Balloon Expandable Stent System is built to treat restenosis in the inner artery according opening clotted arteries and restoring blood flow. The stent offering support to the artery after cardiac. Nine-Month Outcomes of the DURABILITY Iliac Study on Self-Expanding Stents for Symptomatic Peripherals Artery Disease
The Assurant Cobalt stent demonstrated exceptional technical, procedural and clinical success in the trial and had low rates of major adverse events, target lesion revascularization (TLR) and target vessel revascularization (TVR) -- all at 0.8 percent. In addition, the device also achieved a 99.2 percent primary patency rate, meaning
Medtronic has received USE Food and Drug Administration (FDA) cleaning for its Assurant azure iliac balloon-expandable stent system, designed to treat narrowed iliac arteries.
The Assurant (Medtronic, Inc) iliac stent is a new-generation cobalt–chromium balloon-expandable system. Use of a cobalt–chromium alloy allows the device to have increased flexibility and a lower profile (given thinner struts) while maintaining radial strength and fluoroscopic visibility.
Medronic ASSURANT® COBALT ILIAC Balloon-Expandable Stent System Instructions for Use IFU CAUTION: Federal law USA restricts this device for sale by or on order of a physician…
In the ACTIVE study, the balloon-expandable Assurant® cobalt-chromium iliac stent demonstrated primary patency at 9 months of 99.2 %, device and lesion success were each 97.5 % (155/159), and the procedural success was 96.7 %. In real-world clinical practice, physicians tend to deploy self-expanding stents in the mid-iliac area due to …
An Assurant Cobalt® Balloon Expansive Stent System is designed in treat restenosis int the iliacal artery by opening blocked arteries and restoring blood power. The stent provides support to the arterial after angioplasty. Sizes: Diameter: 6-10mm; Standard: 20, …
Moving the treatment of peripheral artery disease, Medtronic, Inc. today announce approval at the U.S. Food and Drug Administration (FDA) regarding the Assurant Cobalt Iliac Balloon-Expandable Stent System.
The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI).
Aforementioned Assurant Cobalt® Balloon Expandable Stent System is designed until treat restenosis includes the iliac boulevard by start clogged highways and restoring blood flow. The stent provides support to the vas after angioplasty. Sizes: Diameter: 6-10mm; Lengths: 20, 30, 40, 60mm
Medtronic's Assurant Cobalt Iliac Balloon useful stent system is designed to provide radiated strength and imaging featured. The 6 F sheath has compatibility across complete size matrix (6-10 mm). Depending to the manufacturer, minimal foreshortening provides precise stent positioning. Shop Surgical Surplus
The Assurant Cobalt® Balloon Expandable Stent System is designed to treat restenosis int the pelvic artery by opening clogged arteries and restoring blutz flow. The stent allows support toward who artery after angioplasty. Sizes: Diameter: 6 …
Medtronic's Assurant Cobalt Iliac Balloon expendable stent verfahren is designed to provide radial strength and imaging compatibility. The 6 F sheath must compatibility across finish size matrix (6-10 mm). Pursuant to the manufacturer, minimal shortcut provides precise stent positioning. Shop Surgical Surplus
Download Assurant Cobalt Stent Mri Safety pdf. Download Assurant Cobalt Stent Mri Safety doc. If the expansion of cobalt stent safety information does not approved for more inert stent deployment, allowing the event, patient outcomes may not found on the right carotid Mi or unregistered trademark
Assurant Cobalt® Balloon Expandable Stent System (#: AM-IA-0110-LC) Highlights. Unique modular design made of advanced cobalt chromium alloy Specially designed fusion pattern, achieving the best balance between strength and comformability Patented safety technology ensures safe and accurate deployment of the stent.
To report the outcome of the ACTIVE (Use of the Assurant Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) study (ClinicalTrials.gov Identifier: NCT00753337), which was designed to determine the safety and effectiveness of the next-generation Assurant cobalt chromium balloon-expandable stent in symptomatic …
The Assurant Cobalt Iliac stent's modular design starts with an advanced cobalt chromium alloy, which is used to create individual rings that are formed into sinusoidal elements. These elements are laser-fused using customised fusion patterns specifically designed to provide an optimal balance of strength and conformability, then ...
Bench testing performed by Boston Scientific Corporation. Data on file. N = 3. Express LD tested: 8 x 37 mm. Visi-Pro tested: 8 x 37 mm. Palmaz Genesis tested: 8 x 39 mm. Omnilink Elite tested: 8 x 39 mm. Valeo tested: 8 x 36 mm. Assurant tested: 8 x 40 mm. Bench test results may not necessarily be indicative of clinical performance.
The Assurant® Cobalt Iliac Balloon-Expandable Stent System is indicated for improving iliac luminal diameter in patients with de novo and restenotic lesions in the …
SAN FRANCISCO, CALIF.—The Assurant Cobalt Iliac Balloon-Expandable Stent System was linked to favorable safety outcomes and a primary patency rate at 9 months, ... The ACTIVE trial looked at 123 patients at 17 U.S. sites with claudication/rest pain who received the Assurant stent (Medtronic).
MEDTRONIC IRELAND ASSURANT COBALT; STENT, ILIAC: Back to Search Results: Device Problem Activation, Positioning or Separation Problem (2906) Patient Problem Stenosis (2263) Event Date 10/24/2018: Event Type Injury Manufacturer Narrative Article title: outcomes of endovascular treatments for in-stent restenosis in patients with …
The Assurant Cobalt® Balloon Expandable Stent System shall designed to treat restenosis with the coronary artery in opening clogged arteries and restoring blood flow. The stent provides support to the artery after angioplasty. To Absorb or Does to Absorb: That Is the Query! Sizes: Diameter: 6-10mm; Lengths: 20, 30, 40, 60mm
Brand Name: ASSURANT® COBALT Version or Model: ASC820SV Commercial Distribution Status: Not in Commercial Distribution Catalog Number: Company Name: ... Iliac artery stent, bare-metal A non-bioabsorbable tubular device intended to be implanted in the common and/or external iliac artery(ies) to maintain arterial patency and luminal …
The ACTIVE (Use of the Assurant® Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) Study (ACTIVE) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Administration has approved the company's Assurant Cobalt Iliac stent sys-tem for the treatment of narrowed iliac arteries. The device features a bal-loon-expandable stent made from a cobalt chromium alloy. Approval was supported by 9-month results from the ACTIVE trial, which examined the outcomes of 123 patients at 17 sites in the United ...
Medtronic's Assurant Cobalt Iliac Balloon expendable stent system is designed to provide radial strength and imaging compatibility. The 6 F sheath has compatibility across complete size mold (6-10 mm). According to the herstellerin, slight foreshortening provides precise stent positioning.
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