Tamir Peleg’s Post

Atrial Fibrillation Treatment Advances as AtriCure, Inc. Secures European Approval for EnCompass® Clamp AtriCure, Inc. has secured regulatory approval for its EnCompass® Clamp in CE-marked countries across Europe, marking a significant advancement in the treatment of atrial fibrillation and related cardiac conditions. Following FDA clearance in 2022, this approval extends the EnCompass Clamp’s reach, allowing European healthcare providers to benefit from its innovative design, which includes parallel closure, uniform pressure, and a magnetic guide that enhances surgical precision and reduces tissue dissection. Michael Carrel, President and CEO of AtriCure, Inc., expressed optimism about the device’s impact on cardiac surgery, noting its potential to improve patient outcomes across Europe, where 400,000 cardiac surgeries are performed annually. For more details please click the link! https://lnkd.in/gKWD_eKN #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

📃Scientific paper: Tubeless PCNL versus standard PCNL for the treatment of upper urinary tract stones: a propensity score matching analysis Abstract: Purpose In this study, the feasibility of tubeless percutaneous nephrolithotomy (PCNL) for the treatment of upper urinary tract stones was investigated. Methods From January 2021 to December 2022, the clinical data of 273 patients who received tubeless PCNL (Group A) were studied. The control group includes clinical data from 302 patients (from January 2019 to October 2022) who received standard PCNL (Group B). The baseline characteristics were consistent between the two groups after using the propensity score matching (PSM) method. Compare the preoperative clinical characteristics, postoperative complications, residual stones, catheterization time, and hospital stay between the two groups. Results 146 pairs of patients were successfully paired through PSM. There was no statistically significant difference in operative time, blood leukocyte counts, haemoglobin decrease, fever, urinary extravasation, sepsis, bleeding, blood transfusion rates, embolism, and residual stones after surgery between the two groups; Postoperative day 1 and discharge day, the VAS pain score in Group A was significantly lower than that in Group B. The catheterization time and hospitalization time of patients in Group A were significantly lower than those in Group B. Conclusion According to the inclusion and exclusion criteria, selecting suitable patients for tubeless PCNL is safe and effective, while significantly alleviating pain and reducing catheterization time and hospital stay. Continued on ES/IODE ➡️ https://etcse.fr/reNa ------- If you find this interesting, feel free to follow, comment and share. We need your help to enhance our visibility, so that our platform continues to serve you.

Exciting Milestone Alert! InspireMD Congratulates CREST-2 Investigators on the Completion of Trial Enrollment. CGuard was the only investigational carotid stent approved by FDA for inclusion in the trials and the CREST-2 trial sites included 23 cases implanted with #CGuard. Brajesh Kumar Lal, MD, Professor of Vascular Surgery at the University of Maryland School of Medicine, and co-principal investigator of the CREST-2 trial, stated, “... This trial, when complete, will ensure that we remain current with state-of-the-art innovation to achieve the best possible short- and long-term patient outcomes. Along with my fellow investigators, we eagerly await topline results from this important study.” Click below for the full details #CREST2 #CarotidStenting #StrokePrevention #MedicalResearch #HealthcareInnovation #ClinicalTrials #FDA #MedicalAdvancement

This single-center retrospective study evaluated the impact of different arterial cannulation strategies on surgical outcomes for patients with acute type A aortic dissection (AD) and intramural hematoma (IMH). #AorticDissection #ArterialCannulation #Cardiopulmonarybypass #SurgicalOutcomes

This single-center retrospective study evaluated the impact of different arterial cannulation strategies on surgical outcomes for patients with acute type A aortic dissection (AD) and intramural hematoma (IMH). #AorticDissection #ArterialCannulation #Cardiopulmonarybypass #SurgicalOutcomes

This single-center retrospective study evaluated the impact of different arterial cannulation strategies on surgical outcomes for patients with acute type A aortic dissection (AD) and intramural hematoma (IMH). #AorticDissection #ArterialCannulation #Cardiopulmonarybypass #SurgicalOutcomes

What are the latest breakthroughs in the medical device industry that are transforming treatment options for patients? Read through this week's #MedtechNews roundup to see the latest updates.   Medtronic released new results from the SMART (SMall Annuli Randomized To Evolut™) trial that compare their Evolut TAVR system to Edwards Lifesciences' Sapien for people who have aortic stenosis and small aortic annuli. The trial, presented at EuroPCR 2024, showed Evolut had significantly less bioprosthetic valve dysfunction and better overall valve performance. The SMART trial is the largest comparative TAVR study to date and includes a majority of female participants (87%). These results highlight the effectiveness of Evolut TAVR in improving outcomes and quality of life for women with aortic stenosis.   https://lnkd.in/ef96MEmt   Arecor Therapeutics plc and Medtronic have partnered to develop a novel, high-concentration, thermostable insulin for next-generation implantable insulin pumps. These pumps will sit under the skin, aiming to reduce maintenance and improve utility for physicians while saving costs. The new insulin is in early development and will require clinical trials to confirm its efficacy. This collaboration seeks to advance treatment options for individuals with type 1 diabetes who cannot tolerate conventional subcutaneous insulin therapy.   https://lnkd.in/e4b7bS7M   GE HealthCare announced a partnership with Medis Medical Imaging to improve coronary artery disease (CAD) care by developing and commercialising the Medis Quantitative Flow Ratio (QFR). This non-invasive diagnostic tool will enhance GE HealthCare’s interventional cardiology portfolio on the Allia Platform, aiming to simplify cath lab procedures and improve clinician workflows. The collaboration seeks to provide emerging technologies like Medis QFR to offer better clinical outcomes, including reduced myocardial infarctions and revascularisations. This partnership marks a significant step in bringing innovative, image-based CAD assessment and treatment solutions to more clinicians and patients.   https://lnkd.in/epqdZdRP #MedTechNews #MedicalDevices #HealthcareInnovation #MedTechIndustry #HealthTech #HealthcareTechnology #MedDeviceNews #HealthcareNews #MedTechTrends

Suprachoroidal Delivery is an exciting new form of treating ocular conditions for blindness. The first disease was uveitic macular edema with the delivery of steroids that led to the FDA approval of Xipere (Bausch + Lomb). We were involved with this Phase 1 Trial for Neovascular AMD which is delivering a tyrosine kinase inhibitor with a suprachoroidal delivery to address the high treatment burden with intravitreal injections. Many companies (Ocular Therapeutix, Inc.; EyePoint Pharmaceuticals; Clearside Biomedical, Inc.; Alcon) are targeting tyrosine kinase inhibitors; and there is an exciting approach with a suprachoroidal injection. https://lnkd.in/gM8pm36Q

InVera Medical (#LSIEurope24 Innovator) is developing a catheter-based therapy for chronic venous disease. Chronic Venous disease occurs when blood is not circulated effectively around the body. It is caused by the failure of one-way valves responsible for preventing blood from flowing backward in veins and results in blood pooling in the legs. Chronic Venous Disease is a progressive spectrum of symptoms where 5% of sufferers experience more advanced symptoms every year. Symptoms begin with varicose veins, which are dilated, tortuous veins. This can progress to pain, heaviness and leg swelling, eczema, and subsequent skin changes leading to the breakdown of the skin, and malodorous leaking venous ulceration, in addition to cosmetic dissatisfaction. InVera™ is the world’s first effective non-thermal medical device to treat varicose veins and venous ulcers, collectively known as chronic venous disease, without harmful side effects. The device uses the body’s natural healing response to treat symptoms allowing all chronic venous disease sufferers to receive treatment for the first time. 🌟 InVera Medical has achieved several major milestones including: • Successfully enrolled the first 10 patients in its pilot EMVA2 clinical trial in Budapest, Hungary with 90% of patients experiencing 81% improvement in Quality of Life baseline scores representing class-leading performance compared to existing non-thermal endovenous ablation technologies. • Successfully completed a usability study with 15 vascular surgeons at the Charing Cross Symposium in London. The study confirmed that the InVera device can be used by the intended users without serious errors or problems, for the intended uses, and under the expected use conditions. • Granted US and EU patents protecting the InVera device technology in key markets. We’re excited to announce that Co-Founder & CEO, Stephen Cox has been selected to present InVera Medical at LSI Europe ‘24 this September 16-20th in Sintra, Portugal. Join us in Portugal to meet with Stephen and learn more about InVera Medical.

At InVera Medical, we're passionate about transforming chronic venous disease treatment. Our non-thermal InVera™ device, leverages the body's natural healing response, offering a groundbreaking solution without the harmful side effects of current treatments. We're committed to improving the lives of millions of patients globally. We’re eager to hear your thoughts on this exciting development: - How do you think non-thermal treatments like InVera™ can reshape the future of chronic venous disease management? - What are your experiences with current #varicosevein and #venouslegulcer treatments? Join us in this conversation! Comment below or reach out if you’re attending LSI Europe – let’s connect and discuss how we can together advance venous health. #MedTech #Innovation #Healthcare #VascularHealth #LSIEurope24