Biofreedom trial

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August undefined, 2024

WebNov 15, 2024 · The One-Month DAPT trial showed that 1 month of DAPT was noninferior to 6-12 months of DAPT at preventing adverse ischemic/bleeding events. Description: The … WebOct 12, 2015 · Patients were randomized to either Biofreedom DCS (n = 1,221) or Gazelle BMS (n = 1,211). Total number of enrollees: 2,432; Duration of follow-up: 2 years; Mean patient age: 75.7 years ... The results of this trial indicate that clinical outcomes following biolimus A9 DCS implantation are superior to BMS in patients with high bleeding risk and ...

Biosensors Receives CE Mark Approval for BioFreedom™

WebBioFreedom™ is a polymer- and carrier-free Drug Coated Stent with BA9™ (DCS). The combination of a selectively micro-structured abluminal surface (SMS) and Biolimus A9™ make BioFreedom™ a unique stent. WebJun 19, 2012 · Treatment. Official Title: A Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug Coated Stent Versus the Gazelle Bare Metal Stent in Patients With High Risk of Bleeding. Study Start Date : December 2012. Actual Primary Completion Date : May 2015. Estimated Study Completion Date : June 2016. flip and sew quilt as you go

Leaders Free III: BioFreedom™ Clinical Trial - TrialBulletin.com

Web开馆时间：周一至周日7:00-22:30 周五 7:00-12:00; 我的图书馆 WebMethods: The BioFreedom US IDE feasibility trial was a single-arm, open-label, prospective study of patients requiring stenting of de novo lesions. Patients received 3 months of DAPT, repeat angiography at 9 months, and clinical follow-up at multiple intervals. A subgroup also underwent intravascular ultrasound (IVUS) interrogation. WebMay 5, 2014 · The BioFreedom U.S. IDE Feasibility Trial is designed to collect additional safety and effectiveness data for the BioFreedom system and to support a future pivotal … flip and sip

Clinical Evidence Biosensors International Ltd

A Randomized Clinical Evaluation of the BioFreedom™ Stent

WebOct 27, 2016 · The BioFreedom polymer-free drug-coated stent (DCS) remained significantly safer and more effective than the bare metal stent (BMS), according to the two-year results of the LEADERS FREE Trial presented Oct. 30 at TCT 2016 and simultaneously published in the Journal of the American College of Cardiology.. In the … WebApr 9, 2024 · Detailed Description. Prospective, multi-center, open-label single-arm study designed to enroll 370 HBR patients (for at least 340 evaluable) at up to 20 centers in up to 2 European countries. 370 patients will receive a BioFreedomTM CoCr stent. All patients will be followed up for 2 years. greater than textWebApr 18, 2024 · Detailed Description: Prospective, multi-center, open-label single-arm study designed to enroll 370 HBR patients (for at least 340 evaluable) at up to 20 centers in up … greater than the mountain

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Biofreedom trial

Biosensors Announces IDE Approval for BioFreedom™ U.S. Trial

WebBioFreedom™ DCS LEADERS FREE 1 was the first clinical trial to evaluate a one-month ultra-short course of DAPT in High Bleeding Risk (HBR) patients with mixed comorbidities. Superior safety and efficacy over the previous gold standard treatment was demonstrated. WebMay 6, 2014 · Biosensors hopes to use data from the study to support a future pivotal trial in the U.S. in pursuit of FDA approval for the BioFreedom stent, a polymer-free device that won CE Mark approval from ...

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WebFirst prospective, randomised, 1-month DAPT trial comparing a DES to a DES in ~2,000 HBR patients. Primary Endpoint Met with Resolute Onyx DES (17.1%) noninferior to … WebMay 21, 2024 · The results of this trial indicate that BioFreedom DCS did not meet criteria for noninferiority for MACE at 1 year compared with the Orsiro DES in an all-comers population with CAD. This was primarily driven by a higher risk of TLR, likely due the difference in stent thickness (120 micrometers for Biofreedom vs. 60-80 micrometers for …

WebSep 22, 2024 · LEADERS FREE II is the company’s new BioFreedom ™ Pivotal Trial, conducted under an FDA Investigational Device Exemption (IDE). It is a prospective single-arm study of the BioFreedom ™ Biolimus A9 ™ drug-coated stent (DCS) with the therapeutic focus on patients at high risk for bleeding (HBR), who receive an ultra-short … WebMay 21, 2024 · In the SORT OUT IX trial, the biolimus A9-coated BioFreedom stent did not meet criteria for noninferiority compared with the ultrathin strut biodegradable polymer sirolimus-eluting Orsiro stent for …

WebJun 25, 2024 · Aims: The aim of this study was to evaluate the efficacy of the new BioFreedom Ultra drug-coated stent with a thin-strut cobalt-chromium platform (BF-CoCr) compared to the BF-SS in an all-comers population undergoing percutaneous coronary intervention (PCI). Methods: This was a prospective, multicentre, non-inferiority trial. WebJun 23, 2024 · The trial was powered to assess noninferiority for major adverse cardiovascular events of the BioFreedom stent compared with the Orsiro stent with a predetermined noninferiority margin of 0.021. Results: Between December 14, 2015 and April 21, 2024, 3151 patients were assigned to treatment with the BioFreedom stent …

WebThe LEADERS FREE trial proved superior safety and efficacy of the BioFreedom™ DCS vs a BMS in the previously understudied and underserved HBR patient population. 2 BioFreedom™ is now listed as …

WebOct 14, 2015 · stent, the BioFreedom stent (Biosensors Europe), has been developed that transfers umirolimus (also known as biolimus A9), a highly lipophilic ... the trial protocol by Centre Européen de Recher - greater than the sumWebMar 22, 2024 · The BioFreedom drug-coated stent ... USA, the Principle Investigator of the trial stated "We are very excited to finally explore the unmet needs of these high … greater than the sum of its parts borderlandsWebBioFreedom Ultra is a thin strut (84μm), cobalt-chromium, carrier-free drug-coated stent with Biolimus A9 drug. The BioFreedom Ultra stent is intended for percutaneous … greater than the sum of our parts audioWebJan 28, 2013 · This trial will provide additional data to support the launch of BioFreedom in select markets during 2013. The full commercial launch is currently anticipated during 2014. About Biosensors ... greater than the sum of its parts meaningWebOct 7, 2015 · The BioFreedom drug-coated stent demonstrated superiority to bare metal stents in patients undergoing percutaneous coronary intervention (PCI) with a high risk of bleeding, according to the results of the LEADERS FREE trial, presented Oct. 14 at TCT 2015 and simultaneously published in the New England Journal of Medicine.. In a … greater than the sum of our parts pdfWebNov 17, 2024 · Subjects will be randomized at a 1:1 ratio to treatment with Resolute Onyx stent or the BioFreedom stent (control). Primary Purpose: Treatment: Official Title: Onyx ONE Study; A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients: Actual Study Start Date : … greater than the sum of our parts schwartzWebMar 22, 2024 · The BioFreedom drug-coated stent ... USA, the Principle Investigator of the trial stated "We are very excited to finally explore the unmet needs of these high bleeding risk patients, who ... greater than the sum of its parts synonym