Casus Consulting’s Post

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!

🔔 MDR and Post Market Surveillance and Vigilance (PMSV) - Since the publication in 2022 of the guidance on the PSUR (MDCG 2022-21) and the publication in Feb 2023 of clarification on the MDR regarding vigilance ( MDCG 2023-3) there has been no publications on the topic. A few weeks ago, were finally released relevant templates for Device Specific Vigilance Guidance as well as templated for specific generic group of devices: 📢 MDCG 2024-1: Device Specific Vigilance Guidance [DSVG] - TEMPLATE https://lnkd.in/ew_FGT7d 📢 MDCG 2024-1-1: DSVG on Cardiac Ablationablation https://lnkd.in/gMPjeeNA 📢 MDCG 2024-1-2 :DSVG on Coronary stents https://lnkd.in/g3r4SNFP 📢 MDCG 2024-1-3:DSVG on Breast Implants https://lnkd.in/g7fnmKNA #mdr #mdrcompliance #mdcg #cemarking #cemark

🔔 MDR and Post Market Surveillance and Vigilance (PMSV) - Since the publication in 2022 of the guidance on the PSUR (MDCG 2022-21) and the publication in Feb 2023 of clarification on the MDR regarding vigilance ( MDCG 2023-3) there has been no publications on the topic. A few weeks ago, were finally released relevant templates for Device Specific Vigilance Guidance as well as templated for specific generic group of devices

Great News丨Lepu Medical's RECATCHOR Exchange Device Successfully Obtained Certification Recently, Lepu Medical (Beijing) Technology Co., Ltd. successfully obtained the medical device registration certificate (Certificate No.: 国械注准20243031479) issued by the National Medical Products Administration (NMPA) for its “RECATCHOR Exchange Device.” This product, designed for anchoring guidewires and assisting microcatheter exchanges, is now ready to enter the market, benefiting numerous patients. Intended Use: The product is designed for percutaneous coronary intervention (PCI), where it stabilizes the guidewire within the guiding catheter by balloon inflation, allowing for smooth catheter exchanges. Product Advantages: ● Ultra-thin Diameter: The anchoring balloon has a diameter of only 0.65mm (significantly smaller than the approximate 0.85mm diameter of a standard PTCA balloon), ensuring easy compatibility with various single-lumen and dual-lumen microcatheters within a 6F guiding catheter. ● Precision Positioning: The metal marker at the distal end of the anchoring balloon provides clear visibility, ensuring precise positioning within the guiding catheter. ● Safety and Reliability: Even when the entire anchoring balloon catheter is inserted into the guiding catheter, the balloon’s distal end does not extend beyond the guiding catheter, reducing the risk of vascular injury. ● Convenient Operation: The catheter can be delivered without relying on a guidewire, avoiding the complexity associated with PTCA balloon systems that depend on guidewires, thus significantly reducing procedure time and enhancing operational convenience. The launch of the RECATCHOR Exchange Device marks another milestone in Lepu Medical’s cardiovascular interventional product portfolio. It provides a safe and convenient solution for stabilizing guidewires within guiding catheters, preventing unintended guidewire movement during microcatheter exchanges, and offering clinicians an innovative and reliable tool for their procedures. #MedicalInnovation #CardiovascularCare #InterventionalCardiology #LepuMedical #MedicalDevices #HealthcareSolutions Contact us 📧>>marketing@lepu-medical.com Visit #lepumedical website for more >>en.lepumedical.com

https://lnkd.in/g3r4SNFP Device Specific Vigilance Guidance - MDCG 2024-1 Important information for Cardiac ablation, Coronary stents Cardiac implantable electronic devices (CIEDs), Breast implants. The documents outline the way to report incidents and serious incidents, defined in Article 2(64) and (65) MDR, in accordance with Articles 87 and 88.

Medtronic DBS best in class MRI labeling for 1.5T full systems with directional leads¹ is now even stronger! The U.S. FDA has approved expanded MRI labeling† for Medtronic Percept™ PC and RC as well as Medtronic Activa™ PC, RC and SC to remove the 30-minute active scan restriction. This means, under certain conditions, the active scan time is unlimited for both 1.5T and 3T scans below specified B1+rms limits, increasing the options available for diagnostic and functional assessments. The updated labeling to remove the 30-minute active scan restriction, along with our exclusive 3T MRI and “always on” capability, provides patients with truly uncomplicated MRI access! https://lnkd.in/g5tTj2zq #MedtronicDBS #Medtronicemployee † Medtronic DBS Systems are MR Conditional. Refer to product labeling for full list of conditions: https://lnkd.in/grn4i9E3

🔹🔸 𝐌𝐃𝐂𝐆 2024-1-4: 𝐆𝐮𝐢𝐝𝐚𝐧𝐜𝐞 𝐨𝐧 𝐭𝐡𝐞 𝐯𝐢𝐠𝐢𝐥𝐚𝐧𝐜𝐞 𝐬𝐲𝐬𝐭𝐞𝐦 𝐟𝐨𝐫 𝐂𝐄-𝐦𝐚𝐫𝐤𝐞𝐝 𝐝𝐞𝐯𝐢𝐜𝐞𝐬 - 𝐃𝐒𝐕𝐆 04 𝐨𝐧 𝐁𝐫𝐞𝐚𝐬𝐭 𝐢𝐦𝐩𝐥𝐚𝐧𝐭𝐬 🔹🔸 💬The aim of this Device Specific Vigilance Guidance (DSVG) is to harmonise vigilance reporting and provide guidance for manufacturers of Breast Implants. It provides further clarification for vigilance reporting of Breast Implants to the relevant Competent Authority and should be read in conjunction with the requirements of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). https://lnkd.in/gT_XNiYE #medicaldevices  #easymedicaldevice #regulatoryaffairs  #regulatoryupdates

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

New document from MDCG

💉 Elixir Medical Corporation’s DynamX BTK system granted FDA Breakthrough Device Designation DynamX is a novel, adaptive implant intended for use in the treatment of narrowed or blocked vessels below the knee (BTK) in patients with chronic limb-threatening ischemia (CLTI). The system leverages the DynamX Bioadaptor platform, a medical technology designed to uncage the vessel and restore normal vessel motion and function after PCI or BTK intervention. With a unique mechanism of action (MOA), the technology maintains dynamic support of the diseased vessel after uncaging, establishing a new standard of care for vascular interventions. Elixir Medical Corporation CEO Motasim Sirhan said: “The Bioadaptor platform was developed to transform treatment of coronary and peripheral artery disease. “We appreciate the FDA recognition of our innovation for treating the CLTI population with BTK disease and its potential impact on the patients suffering from vascular disease.” Peripheral arterial disease (PAD) is a condition characterised by narrowing or blockage of the blood vessels in the leg, primarily caused by the buildup of fatty plaque in the arteries. CLTI is an advanced stage of PAD and is associated with risk to both life and limb, with one-year estimates of mortality over 20% across a range of observational studies. According to Elixir Medical Corporation, DynamX is the only metallic device designed to support the vessel during the healing phase, after which it unlocks the vessel. Read more online: https://lnkd.in/emENpYDY 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #elixirmedical