TÜV SÜD - Healthcare & Medical Devices’ Post

This model includes the inferior and anterior vena cava as well as the left and right atrium. It also includes the iliac and renal veins. Its dimensions are 600 x 250 mm. It is based on CT scans from an actual patient. It is designed for medical device testing and demonstration. 🔗 Learn more: https://lnkd.in/gd3Drfwp 🤙 Talk with our experts: https://lnkd.in/ewuZHD_N #MedicalSimulation #Medical3DPrinting

Penumbra, Inc. Revolutionizes Clot Removal with Lightning Flash 2.0 Exciting news in the world of cardiovascular care! Penumbra, a leading medical device company, has announced the FDA approval and commercialization of its latest innovation, the Lightning Flash 2.0 system. Lightning Flash 2.0 is the next-generation computer-assisted vacuum thrombectomy (CAVT) system designed to rapidly remove venous thrombus and treat pulmonary emboli (PE). Featuring advanced algorithms for increased speed and sensitivity, this system, combined with Penumbra's novel catheter technology, empowers physicians to navigate complex anatomy and deliver superior clot removal with minimal blood loss. According to Penumbra's FSIR chief medical officer, James F. Benenati, M.D., FSIR, "Lightning Flash 2.0 has significantly improved procedure time by shortening the aspiration time and shown reductions in blood removed during aspiration. These advantages can improve patient safety, provide better outcomes, and streamline efficiency for physicians."As the only computer-assisted mechanical thrombectomy systems currently available in the US, Penumbra's Lightning family of products continues to push the boundaries of cardiovascular care. With the launch of Lightning Flash 2.0, the company reaffirms its commitment to advancing patient care and ensuring more individuals can benefit from this transformative technology. https://lnkd.in/eAKaenfB Be sure to follow Practical Patient Care on LinkedIn for more industry news and insights. #PracticalPatientCare #MedicalDevices #CardiovascularCare #ThrombectomyInnovation

📢 Supira Medical receives FDA breakthrough device designation for ventricular assist device The Supira system is a next-generation percutaneous ventricular assist device (pVAD) designed with a novel low-profile, high continuous flow design. The system is intended to provide full hemodynamic support initially for high-risk percutaneous coronary interventions (HRPCI) and subsequently for cardiogenic shock (CS) patients. It features a 10F profile, designed to reduce vascular complications, and multiple sensors to provide real-time pressure measurements, all in a single device platform. Supira Medical president and CEO Nitin Salunke said: “We are thrilled to have received breakthrough device designation and pleased to have the strong, continued support from our investors, both significant milestones for the company. “Early clinical experience with the Supira System has demonstrated that physicians see tremendous clinical value in Supira’s low profile, high continuous flow design, including the system’s sensors intended to collect real-time aortic and ventricular pressures.” Read more online: bit.ly/3Rabhi3 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #supiramedical

#medicaldevices #caediovascuarimplans #endovasculardevices #iso25539 #biocompatibilitytests 🫀List of Biocompatibility tests as per ISO 25539 for implantable devices and it's importance 👉ISO 25539 is a standard for cardiovascular implants, including endovascular devices. Biocompatibility tests required by ISO 25539 include: 🌱Cytotoxicity testing 🌱Sensitization testing 🌱Irritation or intracutaneous reactivity testing 🌱Systemic toxicity testing 🌱Subchronic toxicity testing 🌱Genotoxicity testing Carcinogenicity testing 🌱Implantation testing 🎯The importance of these tests lies in ensuring that implantable devices are safe for use within the human body. They assess the potential risks associated with the materials used in the devices, ensuring they do not cause adverse reactions such as inflammation, toxicity, or immune responses when implanted. These tests are critical for regulatory approval and ultimately for ensuring patient safety and wellbeing.

💉Penumbra, Inc. launches latest CAVT technology to rapidly remove blood clots Lightning Flash 2.0 is the next-generation computer-assisted vacuum thrombectomy (CAVT) system to remove venous thrombus and treat pulmonary emboli (PE). The next-gen CAVT system features advanced Lightning Flash algorithms designed for increased speed and sensitivity to thrombus and blood flow. Together with Penumbra, Inc.’s novel catheter technology, the system will help physicians better navigate through complex anatomy and deliver superior clot removal with minimal blood loss. Penumbra, Inc. FSIR chief medical officer James F. Benenati, M.D., FSIR said: “Based on what we’ve seen in the initial launch, Lightning Flash 2.0 has significantly improved procedure time by shortening the aspiration time. It has also shown reductions in blood removed during aspiration. “These advantages can improve patient safety, provide better outcomes for the patients and streamline efficiency for physicians treating the patients. “As adoption of thrombectomy becomes more widespread, Lightning Flash 2.0 will provide physicians with the confidence that CAVT is a valuable frontline option.” Read more online: https://lnkd.in/eAKaenfB 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #penumbra #bloodclots

📢 Biosense Webster introduces OPTRELL catheter for cardiac mapping Biosense Webster designed the Optrell catheter as a high-density diagnostic catheter. The device is said to have small electrodes arranged in a fixed array formation to generate a high-definition electrophysiological mapping of complex cardiac arrhythmia cases. OPTRELL with TRUEref technology, which received FDA 510(k) clearance in 2022, can map cases like redo AFib ablation, persistent atrial fibrillation (AFib), atrial tachycardia, and ventricular tachycardia. The OPTRELL catheter also contains compact electrodes and tight electrode spacing, which results in increased signal resolution and improved maps of the heart. Read more online: bit.ly/47fqwwi 📰 Follow Medical Device Developments to receive the latest medical device news daily #MedicalDeviceDevelopments #biosensewebster #cardiachealth #catheter #electrophysiology #arrhythmias #atrialfibrillation #diagnostics

Need a DHT to measure blood pressure in your clinical trial? Take a look at this recently approved Nanowear! #DHTs #clinicaltrials #bloodpressuremonitoring

💓 Reflow Medical recruits first patient in Spur Elute trial for in-stent restenosis The study, known as DEEPER CORONARY, will recruit 10 patients at up to three centres in New Zealand. New Zealand’s Wellington Hospital interventional cardiologist and trial principal investigator Scott Harding said: “It’s exciting to take part in the study of this novel platform, which has the potential to successfully treat patients suffering from in-stent restenosis.” Spur Elute addresses coronary ISR in patients by delivering a proprietary sirolimus drug formulation directly to the affected lesion without the use of a permanent metallic implant. Read more online: https://lnkd.in/ebBpZ3y4 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #medicaldevices #medicalmanufacturing

The device specific vigilance guidance have been an important tool under the directives for manufacturers to report vigilance cases in specific groups of devices. Multiple device specific vigilance guidance (DVGS) have reworked to fulfil the medical device regulation and have now been published on the European Commission website. Manufacturers can now find more detailed information on how to report vigilance cases of: Devices for cardiac ablation (MDCG 2024-1-1) Coronary stents (MDCG 2024-1-2) Cardiac implantable electronic devices (CIEDs) (MDCG 2024-1-3) Breast implants (MDCG 2024-1-4) Go check them out: https://lnkd.in/eMDHy_24

Saluda Medical's Evoke SCS system now has #MRI Labelling FDA Approval! This approval applies to commercially implanted Evoke SCS patients in the US and patients formerly enrolled in the ECAP Study. Full article below: #saludamedical #chronicpain #neuromodulation