The CONFORMAL Early Feasibility Study (EFS) data one-year results demonstrated durable closure for LAAO indicated patients with 97.7% seal without significant (>3 mm) leaks at 12 months, comparing favorably with marketed devices.¹ The EFS data also confirmed an impressive 97% sizing correlation between TEE and angiography, to quickly confirm CLAAS device sizing.² 1. Gray W, Conformal Early Feasibility Study: 12 Months Results. Presented at TCT 2023 2. Gray W, Real-Time Atrial Appendage Assessment for LAAO-CLAAS Device Selection: Angiography vs TEE. Presented at CRT 2023 Visit the Conformal website to learn more about the CLAAS System. https://lnkd.in/d6XdifY2 Visit the Conformal website to learn more. https://lnkd.in/eFTc4h7F #Cardiology #LAAO #data #conformalmedical #claas #Afib #CRT2024 #CardioTech #InnovationInTheHeartOfDC #ConformalMedica #interventionalcardiology #electrophysiology CAUTION: Investigational Device The CLAAS System is limited by Federal (or United States) law to investigational use.
Conformal Medical’s Post
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Join Conformal and Industry leaders at #CRT2024 this weekend for cutting-edge insights and advances in the Cardiovascular industry. On Saturday 9, at 5:00 PM: Explore the future with William Gray, MD., as he presents Conformal Self-Adaptable LAA Closure Device: Initial Clinical Experience." Take this chance to be at the forefront of innovative cardiovascular solutions. Then, on Sunday 10, at 3:24 PM, Dive deep into comparative thrombogenicity with William Gray, MD., as he presents "Comparative Acute Thrombogenicity Of The CLAAS Foam Implant And Watchman FLX In An In Vitro Blood Loop Model." Finally, on Tuesday, 13, at 10:39 AM, Aaron Kaplan, MD, will discuss "Conformal: Design and Clinical Data on a Novel LAA Closure Device." Gain insights into a revolutionary LAA closure device's meticulous design and clinical outcomes. See you there! To learn more about the CONFORM Pivotal Trial and the CLAAS System, visit https://lnkd.in/exyWTx-x #Cardiology #LAAO #data #conformalmedical #claas #Afib #CRT2024 #CardioTech #InnovationInTheHeartOfDC #ConformalMedica #interventionalcardiology CAUTION: Investigational Device The CLAAS System is limited by Federal (or United States) law to investigational use.
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Pulsed Field Afib Ablation Superior to Thermal Methods “Pulsed field ablation (PFA) trials continued to accrue positive data, as reported at the Heart Rhythm Society (HRS) annual meeting. Secondary analysis of the pivotal ADVENT trial showed that PFA with the Farawave device was actually superior in one respect to conventional thermal ablation for paroxysmal atrial fibrillation (Afib) in that first randomized head-to-head trial. While the main trial had shown noninferiority for efficacy at 1 year in freedom from atrial arrhythmias, post hoc analysis of the atrial arrhythmia burden calculated from transtelephonic ECG and Holter monitoring showed more patients achieved less than 0.1% residual burden with PFA than with thermal ablation (82% vs 75%, OR 1.5, P=0.04).” https://lnkd.in/eWvjiFgP
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Great news! The #SIMCor consortium has obtained a 6-month extension by the European Commission to consolidate and expand its work on #virtualcohorts and #insilicotrials in #cardiology, including mapping of engineering metrics with clinical outcomes and regulatory approval of #insilico tested medical devices. #SIMCor is a #H2020 #RIA developing a computational platform for #insilico testing and validation of #cardiovascular implantable devices. Check out our mission👇 https://lnkd.in/dSXpF4Q3 #cardiovascular #modelling #simulation #insilicotrials
SIMCor: in-Silico testing and validation of Cardiovascular IMplantable devices
https://www.youtube.com/
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🌟 Exciting News from SCAI 2024 Scientific Sessions! 🌟 The latest breakthrough in cardiovascular care has arrived at SCAI 2024, unveiling significant insights into transcatheter aortic valve replacement (TAVR) with the DurAVR system. 🫀 Key Highlights: • DurAVR TAVR System: Developed by Anteris Technologies, the DurAVR system is engineered with biomimetic features to closely replicate the function of a healthy aortic valve. • Study Outcomes: A groundbreaking study presented at SCAI 2024 demonstrated exceptional results. After one year, all 28 patients who received the DurAVR valve showed no signs of severe or moderate aortic stenosis—a remarkable achievement in cardiovascular intervention. • Hemodynamic Performance: The DurAVR system exhibited superior hemodynamic performance, reflecting optimized blood flow characteristics critical for cardiovascular health. 👨⚕️ Insights from Dr. Azeem Latib: Dr. Azeem Latib, Director of Interventional Cardiology and Structural Heart Interventions at Montefiore Medical Center in New York, emphasized the transformative potential of the DurAVR system. With improved hemodynamics akin to a natural valve, the DurAVR represents a significant leap forward in TAVR procedures. 🔬What's Next? • FDA Approval: While awaiting FDA approval, the DurAVR TAVR system continues to redefine the landscape of TAVR interventions. • Future Developments: Stay updated for forthcoming data releases later this year as ongoing studies further validate the effectiveness and safety of the DurAVR system. 🖇 For more details on this groundbreaking development, visit https://lnkd.in/gGeN8sqk and stay tuned for updates! At ArchCath, we're committed to informing you about the latest cardiovascular technology advancements. Subscribe to our updates, and join us in advancing cardiovascular innovation! 🏥💙 #TAVR #HeartHealth #SCAI2024 #MedicalInnovation #Cardiology #ArchCath
DurAVR™
anteristech.com
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We are thrilled to share two-year late-breaking clinical results demonstrating a statistically significant benefit with DynamX® Coronary Bioadaptor System over standard-of-care Resolute OnyxTM Drug-Eluting Stent: · 65% reduction in target lesion failure (TLF) rate · 68% reduction in target vessel failure (TVF) rate · 78% reduction in TLF rate in left anterior descending (LAD) artery lesions Learn more about the BIOADAPTOR Randomized Controlled Trial (RCT) results: https://lnkd.in/ecWk4dse CE marked. Not for sale in the U.S. #EuroPCR #Bioadaptor #Medtech #Innovation #Cardiology
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📢Biosense Webster receives CE mark for Varipulse PFA Platform The Varipulse Platform, which comprises the Varipulse Catheter, Trupulse Generator, and Carto 3 System, is intended to treat symptomatic drug refractory recurrent paroxysmal AF. Varipulse Catheter is a variable-loop multielectrode catheter, Trupulse Generator is a multichannel PFA generator and Carto 3 System is a 3D cardiac mapping system. According to the company, the Varipulse Platform is the first and only Carto-integrated PFA system that enables reproducible workflow with real-time visualisation and feedback set-up. Biosense Webster president Jasmina Beslagic Brooks said: “At Biosense Webster, we continually seek to push the boundaries of science and technology innovation in cardiac ablation. “CE mark approval of the VARIPULSE Platform is testament to this, now offering healthcare professionals the potential to improve outcomes for people living with atrial fibrillation while setting a new standard in cardiac electrophysiological mapping. “We believe pulsed field ablation has the potential to offer safer, more consistent and efficient workflows, and the VARIPULSE Platform uniquely offers physicians a simple and reproducible PFA workflow with 3D visualization, in real-time.” Biosense Webster said that the safety and efficacy of the Varipulse Platform were validated in the inspIRE trial, which included 186 patients in Canada and Europe. Read more online: https://lnkd.in/ef4e5Adv 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #biosensewebster #johnsonandjohnson
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Medtronic receives #FDA approval for their Inceptiv™ closed-loop rechargeable spinal cord stimulator (SCS) 🧠 💪 It is the first of its kind to offer a closed-loop feature, automatically adjusting stimulation in real time to keep therapy in sync with daily activities. Traditional SCS devices may cause discomfort during certain movements, leading to suboptimal therapy experiences. Inceptiv is able to sense biological signals and maintain tailored stimulation, ensuring a more consistent and effective treatment. David Carr, VP and General Manager for Pain Intervention at Medronic said: "A new era for spinal cord stimulation technology is beginning, and with Inceptiv SCS, Medtronic is at the forefront," "For patients dealing with chronic pain, every day is a struggle. They deserve personalized and effective relief, without compromising future access to MRI. They deserve the comfort that the smallest and thinnest device on the market can provide. We are proud to offer the most cutting-edge solution available today with Inceptiv SCS." Medtronic will initiate the U.S. market launch of Inceptiv in the coming weeks. #neurotech #spinalcordstimulation #medicaldevice
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Haemonetics to buy Attune Medical for $160M. Attune’s device to help cool the esophagus during radiofrequency ablation procedures is a key piece of the acquisition. #Haemonetics #Ablation #RFAblation.
Haemonetics to buy Attune Medical for $160M
medtechdive.com
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Facet Replacement Fda Study Garners Best Paper Award At Lumbar Spine Research Society Meeting — PRBuzz.co — Premia Spine's #study on the #TOPS #System showcasing its advantages over #traditional lumbar #fusion received the #Best #Paper #award at the LSRS #2024 #Annual #Meeting This #recognition underscores the system's ability to #improve #patient outcomes and #quality of #life by allowing #natural spinal motion. NORWALK, Conn., May #2 2024Premia #Spine a #leader in #innovative spinal #treatment #solutions #today announced that the pioneering study titled "Lumbar Facet Arthroplasty for Degenerative Spondylolisthesis with Stenosis: Interim #Analysis of Three-Year Outcomes from a Prospective Randomized Clinical Trial" has been awarded the prestigious Best Paper at the Lumbar Spine Research Society
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Elixir Medical's Lithotripsy System Shows Promise in Treating Coronary Artery Lesions: Elixir Medical's successful clinical trial of LithiX Hertz Contact Intravascular Lithotripsy (IVL) System achieves 98% clinical success and 100% angiographic success in treating calcified coronary artery lesions. The study results in a 1.7% MACE rate, demonstrating promising outcomes in coronary artery treatment.. https://lnkd.in/gx_swVhx
Elixir Medical's Lithotripsy System Shows Promise in Treating Coronary Artery Lesions
ctol.digital
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