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Field Medical's FieldForce™ Ablation System Earns FDA Approval

Field Medical® Inc., a leading innovator in pulsed field cardiac catheter ablation technology, has recently announced a significant milestone for its FieldForce™ Ablation System. This advanced system has been granted acceptance into the FDA's Total Product Life Cycle Advisory Program (TAP) Pilot and has also received the coveted Breakthrough Device Designation. Both recognitions highlight the system's role in addressing sustained monomorphic scar-related ventricular tachycardia (VT), a critical and life-threatening condition affecting countless individuals globally.

Groundbreaking Technology to Combat Ventricular Tachycardia

Ventricular tachycardia is a serious condition that can lead to sudden cardiac death. It accounts for approximately 450,000 deaths each year in the United States alone, often due to its complex nature and current treatment limitations. The FieldForce™ Ablation System stands out as the first and only contact force pulsed field ablation (PFA) system meticulously engineered to treat this arrhythmia effectively.

The FDA's TAP Pilot and Breakthrough Device Designation are given to medical devices that show promise for more effective treatments compared to existing options. This reflects a commitment from the FDA to help speed up patient access to innovative medical solutions.

Dr. Steven Mickelsen, the CEO of Field Medical, emphasized the significance of these recognitions in their pursuit of regulatory approval, noting, _"This recognition advances our vision of equipping electrophysiologists with a next-generation, focal PFA tool for fast, accessible VT care."_

Urgent Need for Innovative Solutions

According to Dr. Vivek Reddy, Director of Electrophysiology at Mount Sinai Health System, the recognition of this breakthrough technology underlines the urgent requirement for novel approaches in the treatment of complex ventricular tachycardia. He stated that _"Field Medical's ablation system has the potential to redefine VT care for physicians and patients alike."_

The FieldForce™ Ablation System utilizes proprietary FieldBending™ technology to deliver targeted, high-intensity electric fields, creating precise lesions necessary for effective ablation. This innovative system aims to provide comprehensive solutions that extend beyond traditional pharmacological therapies, which are often only partially effective for a considerable percentage of patients.

Addressing the Complexities of VT Treatments

Current pharmacological approaches for ventricular tachycardia have a failure rate of about 30-50%, showcasing the pressing need for innovative ablation solutions like the FieldForce™ system. By reorienting treatments that target and address VT directly, Field Medical provides hope for better outcomes and survival rates.

Field Medical, founded in 2022, is leading the charge in next-generation pulsed field ablation technologies. The company is spearheaded by Dr. Mickelsen, whose pioneering work has set the foundation for advancements in medical technologies aimed at transforming cardiac care for millions.

In summary, the FieldForce™ Ablation System encapsulates a transformative leap in treating ventricular tachycardia, offering a glimmer of hope for improved patient outcomes through innovation and advanced technology. As this system prepares to enter clinical settings, it marks a pivotal moment for both the medical community and patients suffering from this dangerous arrhythmia. Field Medical's ongoing commitment to enhancing cardiac care through innovative solutions highlights the importance of reliable therapies that can significantly reduce mortality rates and improve quality of life for those at risk.

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