Grove Technical Resources, INC’s Post

The MDCG released guidances to harmonize vigilance reporting for serious incidents, Periodic Summary Reports, and trend reporting for specific types of devices. "Specific Device" guidances are now available for the following high-risk products: Cardiac Ablation devices, Coronary Stents, Cardiac Implantable electronic devices (CIEDs) and Breast Implants. The guidances provide examples of what can be submitted under each type of reporting mechanism. For example, a serious incident that should be reported individually vs. serious incidents compiled under a Periodic Summary Report vs. a trend report. Click below for more details and links to the guidances. https://lnkd.in/eMP3U_Wp

Reviewing Endovascular and Conventional Angioplasty: Challenges in Modern Patient-Centered Care https://lnkd.in/et3ezgRK

Evasc Neurovascular Expands European Presence: Milestone Achievement with Eclips Device and Launch of German Subsidiary Evasc Neurovascular, a leading medical technology company specializing in endovascular repair solutions for cerebral aneurysms, proudly announces its strategic growth initiatives. The company has achieved a milestone of 120 successful cases with its innovative Eclips device and is expanding its European operations with the establishment of a new subsidiary, Evasc Neurovascular GmbH, headquartered in Germany. This expansion signifies a significant leap forward in Evasc's commitment to providing enhanced neurovascular care solutions in Europe. By establishing a direct presence in Germany, Evasc aims to facilitate more efficient services and direct sales, solidifying its position as a key player in the European market. In parallel with this expansion, Evasc reports noteworthy progress in the France EESIS trial, a crucial component of the company's ongoing efforts to validate the efficacy and safety of its groundbreaking neurovascular treatments. The strategic move into Germany positions Evasc to contribute even more significantly to the advancement of neurovascular care throughout Europe. Evasc's success extends beyond geographical boundaries, with increasing recognition and adoption within the NeuroInterventional Radiology (NIR) community. Its cutting-edge solutions have demonstrated remarkable promise, particularly in the treatment of wide neck bifurcation aneurysms—an area that has historically presented challenges within neurovascular care. In the current year alone, Evasc has successfully treated 80 patients, achieving a commendable milestone in the company's history. This accomplishment underscores Evasc's unwavering dedication to improving patient outcomes and advancing neurovascular care. As part of Evasc Neurovascular's commitment to advancing patient care, the establishment of Evasc Neurovascular GmbH in Germany underscores the company's dedication to localizing support and resources for its European clientele. The move aims to foster stronger relationships with healthcare professionals and institutions, ensuring timely access to Evasc's innovative neurovascular solutions. This strategic expansion aligns with the company's vision of making a meaningful impact on the global landscape of cerebral aneurysm treatment, reinforcing Evasc Neurovascular's position as a trusted partner in the pursuit of better care and improved outcomes. "Our expansion into Germany and our ongoing success in clinical trials and patient treatments are demonstrations of the Evasc dedication to excellence and paving new ground in the world of neurovascular health,” commented a spokesperson from Evasc Neurovascular. “This positive momentum will only continue. We are confident our company will continue to be instrumental in shaping the landscape of neurovascular care worldwide."

Anteris Technologies has achieved a significant breakthrough in heart valve treatment with the completion of three complex valve-in-valve (ViV) procedures using its innovative DurAVR™ transcatheter #heart valve. These procedures were under Health Canada’s special access program (SAP) which allows healthcare professionals to access unlicensed #medical devices, such as DurAVR, for emergency use when conventional therapies have failed, are unavailable or are unsuitable to treat a patient. The transcatheter ViV replacement is performed by implanting a #transcatheter heart valve within a failing bioprosthetic aortic valve, a less invasive procedure compared with reoperative surgical aortic valve replacement. More at http://ow.ly/QEII105ahFN #ASX #OTC #AVR #AMEUF #Proactive #ProactiveInvestors

The MDCG issued new vigilance guidance yesterday. It's intended to harmonize reporting requirements, in particular for some specific high-risk devices, like coronary stents. And provides examples of what might be individually reported as serious incidents vs. combined under a Periodic Summary Report vs. incidents submitted in a trend report. Click below for the links and a fuller overview!

Understanding Endovascular Procedures - A common man’s Guide

Last week ICU Medical Technologies obtained the patent for KronoSafe® in the USA. With this milestone, the expansion of protection internationally by choosing strategic commercialization countries continues. This recognition is added to the patents already granted (Spain and Russia) and also, the extension process continues favorable in other countries such as India, China, Canada, Australia and the rest of Europe. USA is an interesting market for a medical device like KronoSafe®, designed to increase the safety and effectiveness of temporary cardiac pacing. In 2022, the turnover of cardiovascular devices in the USA was USD 28.6 billion and with expectations of future growth (CAGR; 7.9%). KronoSafe® not only provides benefits in the field of Temporary Cardiac Stimulation directly, which in the United States represents an annual turnover of €202M (CPT Code 33210-1 / $8,103); but also in patients undergoing Transcatheter Aortic Valve Replacement (#TAVR), where favorable clinical results have been confirmed with this device. This market, with an annual turnover in the USA of $3.2B (CPT code 33361-66 / $45,000) will be an interesting Early Adopter. Reducing complications with a high economic impact, reducing costs in hospital stays and avoiding overuse of permanent pacemakers will be an interesting solution for both hospitals and insurers. #cardiology #pacemaker #cardiacstimulation #icu, #medicaldevice

📢 EndoSound secures FDA 510(k) approval for EndoSound Vision System The EVS is a novel endoscopic ultrasound (EUS) device that attaches to upper gastrointestinal endoscopes, easily integrates into any endoscopy centre’s existing ecosystem, and provides a more economical offering and enhanced access to critical procedures EUS is a minimally invasive procedure that involves high-frequency sound waves to produce detailed images to help assess the diseases of the pancreas, liver, and gallbladder. The EVS is said to advance the EUS procedures with a more economical offering and provide greater access to critical imaging and therapeutic procedures. Read more online: https://lnkd.in/edptHBFu 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments

Further evidence to support our position at True You Weight Loss that a simple, single-day liquid fast is sufficient to allow for complete gastric emptying in patients on GLP-1 meds undergoing endoscopic or surgical procedures, as we showed in our own recent study. Forcing patients to interrupt or discontinue their GLP treatment solely for a procedure is unfounded and unnecessary. 24 hours of liquids is more than sufficient and should be adopted as the standard approach. https://lnkd.in/eBTDHhCp Read our study here: https://lnkd.in/eqJwiDSe

#optometrists, you have a patient in your chair with narrow angles. Gonioscopy revealed < 2 quadrants of visible TM. Refer for LPI or LE? LPI is the standard of care. Several studies have indicated lens extraction being superior to LPI in IOP control. This meta-analysis (combining all the data from all the good and applicable RCTs) found no difference between LPI and LE in terms of IOP control, number of residual medications, and VF progression. Although LE remains a good option for our patients with narrow angles, LPI remains the standard of care for most. #evidencebasedmedicine #optometry #eyecare #eye #2020habits https://lnkd.in/gt68Htj3