Medical Device Developments的动态

?? Field Medical starts FIH study for FieldForce Ablation System The FieldForce Ablation System is said to be the first and only contact force pulsed field ablation (PFA) system for the time-efficient treatment of people with ventricular arrhythmias. The Ventricular Catheter Ablation Study (VCAS) will assess the FieldForce system at Na Homolce Hospital in Prague, Czech Republic. VCAS will recruit up to 60 patients at up to five sites worldwide. The system’s potential will be assessed to address the limitations of existing PFA and radiofrequency (RF) ablation systems. It will be conducted in two parts where the VCAS-1 group concentrates on patients afflicted with?ventricular tachycardia?(VT). On the other hand, the VCAS-2 group is aimed at those encountering frequent premature ventricular complexes (PVCs). The trial seeks to establish that PFA can safely manage and enhance overall outcomes for patients with complex ventricular arrhythmias. Field Medical CEO Steven Mickelsen said: “Our vision at Field Medical is to transform VT ablation into a widely available, one-hour outpatient procedure with improved safety outcomes. “With the promising early data for our VCAS study, in much the same way that PFA transformed AF, the FieldForce Ablation System is optimised to transform how ventricular arrhythmias are treated, offering hope to millions of patients worldwide. “With the strong investor support, renown physician engagement and the groundbreaking potential of our technology, we are set to redefine the standards of cardiac ablation once again.” Read more online: https://lnkd.in/gKCk7rgK ?? Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #medicaldevices #medicalmanufacturing

Is Boston Scientific Leading the Future of AFib Treatment? The company recently secured FDA approval for its groundbreaking Farawave Nav ablation catheter, designed to treat paroxysmal atrial fibrillation (AFib). This innovation combines cardiac mapping and pulsed-field ablation (PFA) therapy into one integrated catheter, offering a significant step forward in AFib treatment. Alongside the Farawave Nav, the company gained 510(k) clearance for its Faraview software, which provides real-time visualisation of catheter placement during procedures. The Farawave Nav probe uses magnetic navigation to enhance precision and reduce the need for device exchanges, while the Faraview software tracks cumulative ablation, helping physicians visualise their progress. These systems are fully compatible with Boston Scientific’s Opal HDx mapping platform. Since its launch earlier this year, Boston Scientific’s Farapulse system has treated over 125,000 AFib patients worldwide, leveraging PFA technology, which offers a safer alternative to traditional ablation methods. By integrating mapping and ablation, Boston Scientific is taking a clear lead in the race to provide safer, more efficient AFib solutions. For the latest updates in the medical device industry, follow TRESP Recruitment - Medtech and Healthtech Experts Recruitment. https://lnkd.in/gCaxgwj9 https://lnkd.in/gnM4ekeJ #MedTechNews #MedicalDevices #HealthcareInnovation #MedTechIndustry #HealthTech #HealthcareTechnology #MedDeviceNews #HealthcareNews #MedTechTrends

? Medtronic gets FDA nod to study Affera System with Sphere-9 Catheter Affera is a dual-energy pulsed field (PF), radiofrequency (RF) ablation system, and Sphere-9 is a high-density mapping catheter. The system is designed to be used in cardiac electrophysiology ablation. Medtronic will assess the Affera System with Sphere-9 Catheter in treating patients with ventricular tachycardia (VT), due to scarring from a prior myocardial infarction (heart attack). The primary endpoints of the study include the rate of serious adverse events (SAEs) after the ablation procedure and acute effectiveness at ablating the targeted VT. Read more online: https://lnkd.in/eP2AX98x ?? Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #medicaldevices #medicalmanufacturing

??Provisio Medical secures FDA clearance for Provisio SLT IVUS System Provisio SLT IVUS System is designed to facilitate simultaneous visualisation and measurement of vessel lumens while providing guidewire support and delivering radiopaque contrast agents. Provisio Medical’s catheter is said to be the first integrated?intravascular imaging?and support crossing catheter globally. The US-based medical device company said that SLT technology offers automatic, real-time, and precise numeric measurements of blood vessel lumens. This removes the challenges of image interpretation and optimises treatment strategies. Provisio Medical CEO S. Eric Ryan, M.D. said: “Clinical outcomes in peripheral vascular disease have consistently been shown to benefit from accurate intravascular measurements, yet adoption has been limited by the additional procedure time and training required to interpret images. “Thanks to the ease-of-use of SLT IVUS, which can be incorporated more efficiently in the peripheral vascular workflow, we believe there is the possibility of increased adoption and therefore improved outcomes for many more patients with potentially devastating peripheral vascular disease.” Read more online: https://lnkd.in/exVJvDRZ Video Courtesy of Provisio Medical ?? Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #provisiomedical #catheter

???Myval TAVR Valve Shows Promising 30-Day Results!??? We at ArchCath love keeping our community updated with the latest cardiovascular innovations. This week, we're spotlighting some amazing findings from the EuroPCR 2024 conference in Paris. Let's dive into the details! ???? The Myval TAVR valve, developed by Meril Life Sciences, is gaining attention for its promising short-term outcomes. Meril Life Sciences, an India-based medical device company founded in 2006, has been making strides with its balloon-expandable transcatheter heart valve. Recent data shows that Myval's performance is non-inferior to that of leading devices from Medtronic and Edwards Lifesciences. ???Key Highlights: ??The LANDMARK Trial: Involved 768 low-risk patients with severe aortic stenosis, randomized to receive either the Myval valve or a contemporary TAVR valve. ??Primary Composite Endpoint: At 30 days, both groups had similar results regarding mortality, stroke, severe bleeding, kidney injury, vascular complications, paravalvular leak, and the need for a permanent pacemaker. Myval group had a 24.7% endpoint occurrence vs. 27.6% in the comparison group. ?? ??Why This Matters: The Myval valves are proving to be just as reliable as the Evolut and Sapien 3 devices, the current gold standards in TAVR care. Available in multiple sizes (from 20 mm to 29 mm), they ensure a better fit and potentially better long-term outcomes. Approved in both India and Europe, Myval is still awaiting FDA approval in the US. ???Expert Insights: Dr. Andreas Baumbach highlighted the valve's safety, efficacy, and unique intermediate sizes, which could lead to improved long-term outcomes. Sanjeev Bhatt emphasized the valve's adaptability to challenging anatomical structures and its overall benefit to the medical community and patients. ???Looking Forward: These findings are based on 30-day data, but follow-up research will continue for 10 years! Keep an eye out for the upcoming publication in The Lancet in 2024 for more detailed results. ?? Stay tuned for more updates from the heart-tech world! ?? ?? To read more about it, please visit https://lnkd.in/dxVgGr2A #TAVR #HeartHealth #CardiovascularInnovation #MedicalResearch #EuroPCR2024 #MyvalValve #MedTech #ArchCath

If you’re passionate about cutting-edge cardiovascular tech, this is a must-read! The Myval TAVR valve by Meril Life Sciences has shown outstanding 30-day outcomes at the EuroPCR 2024 conference in Paris. ???? ?? The LANDMARK trial involving 768 low-risk patients with severe aortic stenosis revealed that the Myval valve is on par with top Medtronic and Edwards Lifesciences devices. With remarkable results in key areas like mortality, stroke, and severe bleeding, Myval is proving to be a reliable and adaptable solution for patients with challenging anatomical structures. ?? For heart health enthusiasts and med-tech followers, this breakthrough promises better long-term outcomes and exciting future research. Dive into the details in the post below, and stay tuned for more updates! #HeartHealth #MedTechInnovation #EuroPCR2024 #MyvalTAVR #ArchCath

Positive results for medical device designed to improve symptoms of pulmonary embolism AngioDynamics, a US based medical device company, have announced that their AlphaVac F1885 System has proven itself to be safe in patients with acute intermediate-risk pulmonary embolism (PE). The device is designed to improve right ventricular function and also reduce the risks of clot burden. The device has received FDA clearance following the positive conclusion of the trial which far surpassed expectations. Serious adverse effects only occurred in 4.1% of cases, much lower than the expected average of 45%, and the improvement in right ventricular function was measured at over 3x that which was expected from the research before the study took place. PE occurs when a blood clot forms in a blood vessel in the lung, usually following deep vein thrombosis in patients. The blockage can cause strokes or cardiac arrest and is considered a serious life threatening condition. By improving heart health and reducing clot burden, AngioDynamics’ device really transforms outcomes for patients suffering with PE. The trial proving to be so much more successful than even the researchers’ predictions is a really encouraging sign for the device. It’s hoped that the device will be able to support more patients with PE soon. For opportunities in the medical device industry, please call us on 01707 246 299. SJ Sourcing Or please visit our website for more information: https://bit.ly/44BDBip

?? Intravascular Lithotripsy (IVL): Innovative Solution for Vascular Calcification Treatment?? Arterial calcification presents a major challenge in cardiovascular treatment. Not only can it obstruct blood flow, but it also increases the risk of myocardial infarction and other severe cardiovascular events. Traditional treatment methods often struggle to effectively address these calcified plaques. However, Intravascular Lithotripsy (IVL) is offering a breakthrough solution. By delivering precise ultrasonic shock waves, IVL effectively breaks down calcified tissue, restoring vessel patency. ?? ? According to the American College of Cardiology (ACC) report, ?ACC, Ten Points on IVL, June 2021, IVL achieves approximately 90% success in treating severe calcified lesions. Compared to traditional angioplasty, IVL carries a lower risk of damage to vessel walls, potentially reducing postoperative complications. ?? ? Nextron's medical connectors comply with IEC 60664-4 certification, ensuring stable performance within a voltage range of 2000 to 5000VDC. These connectors are widely used in IVL catheters and high-frequency energy connectors, trusted by leading global medical device manufacturers and implemented in clinical settings, showcasing Nextron's reliability and stability in medical applications. ?? Read the full article here : https://lnkd.in/ggqFgRUT #CardiovascularTherapy #IVL #Nextron #VascularCalcification #MedicalDevices

Positive results for medical device treating atrial fibrillation Kardium Inc. has reported positive results for their Globe field mapping and ablation system, specifically designed for the treatment of atrial fibrillation (AF). AF is a relatively common heart condition characterised by rapid heart rhythm, which can actually lead to more serious complications such as strokes and clots in the heart. Kardium’s Globe field mapping and ablation system consists of a catheter with 122 electrodes that deliver rapid, single shot pulmonary vein isolation (PVI) during ablation. The device is designed to be a single-use device, capable of destroying the area responsible for the irregular heart rhythm, meaning the condition can be cured using this system, with only a potential pacemaker necessary afterwards. The trial proved that the system was capable of acute PV isolation in 100% of cases on a short term basis. One year on from the system’s first use, 84.2% of patients previously suffering from paroxysmal AF, and 80% of persistent AF patients, were completely AF free, showing strong long term outcomes, too. No major adverse events were reported during the PULSE-EU trial either, and the average time for PV isolation across all patients was just 23 minutes, showing the device is quick to act, too. It’s hoped that the device’s strong performance can continue in the future should it become more widely available. For opportunities in the medical device industry, please call us on 01707 246 299. SJ Sourcing Or please visit our website for more information: https://bit.ly/3yMIhX2