GERMANY —Biotronik, a leading medical technology company, has announced that the U.S. Food and Drug Administration (FDA) has granted approval for its portfolio of pacemakers and cardiac resynchronization therapy pacemakers.
These advanced devices are equipped with automatic MRI detection capabilities, streamlining the MRI workflow for healthcare providers and patients alike.
The pacemakers, known as Amvia Edge, incorporate proprietary sensors that enable them to automatically recognize when a patient enters an MRI field.
This innovative feature allows the device to seamlessly switch to MRI mode, ensuring patient safety during the scan.
After the completion of the MRI, the pacemaker seamlessly returns to its permanent programming, eliminating the need for pre- or post-scan programming adjustments.
Biotronik’s Amvia Edge is proudly touted as the smallest single-chamber MR conditional pacemaker available on the market.
Amvia Edge pacemakers offer additional features, such as Atrial ATP, which provides automatic therapies to address stable atrial arrhythmia.
This capability aims to reduce atrial tachycardia burden and prevent atrial remodeling. Furthermore, the devices introduce tools for automating major tasks, including pre-discharge checks, simplifying the workflow for healthcare professionals.
Ryan Walters, President of Biotronik, expressed the company’s commitment to healthcare professionals in delivering innovative solutions. He stated, “Amvia Edge represents Biotronik’s continued commitment to healthcare professionals to help them serve their patients.
“The clinical treatment options and built-in efficiencies of Amvia are designed to solve everyday challenges for patients, physicians, and caregivers.”
In a separate development, Biotronik has formed a partnership with Philips, an Amsterdam-based medtech company, to expand outpatient cardiology lab care.
Together, they aim to enhance patient access, personalization, and cost-effectiveness in treating cardiovascular and endovascular conditions.
Philips has developed SymphonySuite specifically for cardiovascular Outpatient Labs (OBLs) and Ambulatory Surgery Centers (ASCs).
This comprehensive suite offers specialized equipment, tailored services, financial solutions, and operational support.
The collaboration with Biotronik brings additional benefits to SymphonySuite, including the integration of Biotronik’s cardiac rhythm management portfolio.
By expanding the selection of devices, the partnership aims to further customize patient care in OBLs and ASCs.
Additionally, the two companies are dedicated to developing low-risk cardiac procedures that can be performed in outpatient settings, leveraging the advantages of out-of-hospital treatment options to improve patient access, personalization, and reduce the risk of hospital-acquired infections.
By combining Philips SymphonySuite with Biotronik’s expertise and product portfolio, patients can benefit from a more personalized approach to care, reduced costs, and improved access to high-quality treatment.
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