Medtronic, a global leader in medical technology, has recently announced that its next-generation Micra leadless pacing systems have been granted the CE Mark. This significant milestone allows Medtronic to market and sell the Micra AV and Micra VR devices in Europe and other countries that recognize the CE Mark.
The Micra leadless pacing systems are revolutionary devices that provide cardiac pacing therapy without the need for traditional leads. Traditional pacemakers require leads to be implanted into the heart, which can be invasive and carry certain risks. However, the Micra leadless pacing systems are small, self-contained devices that are implanted directly into the heart, eliminating the need for leads.
The Micra AV and Micra VR devices are the latest additions to Medtronic’s Micra family of leadless pacing systems. The Micra AV is the world’s smallest pacemaker with atrioventricular (AV) synchrony, meaning it can sense and respond to the electrical signals in both the atrium and ventricle of the heart. This allows for a more natural and synchronized heartbeat, improving patient outcomes.
The Micra VR, on the other hand, is a single-chamber pacemaker that provides ventricular pacing therapy. It is designed for patients who only require pacing in the ventricle of their heart. Both devices are significantly smaller than traditional pacemakers, about the size of a large vitamin capsule, and can be implanted using minimally invasive techniques.
The CE Mark approval for the Micra AV and Micra VR devices is a testament to their safety and efficacy. The CE Mark is a certification that indicates a product meets certain regulatory requirements and can be marketed and sold within the European Economic Area. It is recognized as a gold standard for medical device safety and performance.
The Micra leadless pacing systems have already been proven to be effective in clinical trials. The Micra Transcatheter Pacing System (TPS), the first-generation device, has been implanted in over 100,000 patients worldwide. Clinical studies have shown that the Micra TPS is associated with a significantly lower risk of complications compared to traditional pacemakers, such as infection and lead-related issues.
With the introduction of the Micra AV and Micra VR devices, Medtronic aims to further improve patient outcomes and expand the options available for cardiac pacing therapy. These devices offer a less invasive alternative to traditional pacemakers, reducing the risks associated with lead implantation and providing patients with a more comfortable and convenient solution.
In addition to their small size and leadless design, the Micra AV and Micra VR devices also feature advanced technology that allows for remote monitoring and programming. This enables healthcare providers to monitor patients’ heart rhythms and adjust pacing settings without the need for in-person visits. This remote capability is especially valuable in times of crisis, such as the ongoing COVID-19 pandemic, where minimizing unnecessary hospital visits is crucial.
The CE Mark approval for Medtronic’s next-generation Micra leadless pacing systems is a significant achievement that will benefit patients in Europe and other countries. These devices offer a safer and more convenient alternative to traditional pacemakers, improving patient outcomes and quality of life. With their advanced technology and remote monitoring capabilities, the Micra AV and Micra VR devices represent the future of cardiac pacing therapy.
- SEO Powered Content & PR Distribution. Get Amplified Today.
- PlatoData.Network Vertical Generative Ai. Empower Yourself. Access Here.
- PlatoAiStream. Web3 Intelligence. Knowledge Amplified. Access Here.
- PlatoESG. Carbon, CleanTech, Energy, Environment, Solar, Waste Management. Access Here.
- PlatoHealth. Biotech and Clinical Trials Intelligence. Access Here.
- Source: Plato Data Intelligence.
- Source Link: https://platohealth.ai/medtronic-receives-ce-mark-for-its-next-generation-micra-leadless-pacing-systems-medical-device-news-magazine/
An Overview of the FDA’s Draft Guidance on Translation of GLP Study Reports in the United States
An Overview of the FDA’s Draft Guidance on Translation of GLP Study Reports in the United States The Food and...