Field Medical's FieldForce™ System Gains FDA Breakthrough Designation

Field Medical Revolutionizes Cardiac Care with New Designation

Field Medical® Inc. has marked a significant milestone in cardiac treatment innovation with its FieldForce™ Ablation System. This cutting-edge system has attained the esteemed FDA's Total Product Life Cycle Advisory Program (TAP) Pilot acceptance, along with the designation as a Breakthrough Device for the treatment of ventricular tachycardia (VT). This recognition highlights the urgent need for advanced solutions to combat the life-threatening effects of VT, which affects countless patients globally.

Pioneering the Future of Ventricular Tachycardia Treatment

As the first and only contact force pulsed field ablation (PFA) system engineered explicitly for VT, Field Medical's FieldForce™ has positioned itself at the forefront of cardiac device technology. With an innovative design focused on enhancing patient care, this system aims to mitigate the significant risks associated with ventricular tachycardia that can lead to severe health consequences. It is expected to revolutionize how health professionals treat this condition, offering patients a more effective alternative to traditional therapies.

Significance of FDA Recognition

The FDA's TAP Pilot and Breakthrough Device Designation are awarded to devices that promise more effective treatments compared to existing options, reflecting the agency's commitment to accelerating patient access to pioneering medical solutions. By receiving this designation, the FieldForce™ Ablation System affirms its potential to transform the approach to VT treatment.

A Closer Look at the FieldForce System

The FieldForce™ Ablation System embodies state-of-the-art technology aimed at delivering optimal outcomes for patients at risk of sudden cardiac death (SCD) from ventricular tachycardia. One of the most distressing statistics reveals that SCD accounts for nearly 450,000 deaths each year, with numerous cases linked to VT. The system empowers electrophysiologists with advanced tools designed for quick and accessible intervention, emphasizing safety and efficacy in patient treatment.

Expert Insights on the Device

Dr. Steven Mickelsen, CEO of Field Medical, expressed enthusiasm regarding the FDA's recognition, stating, "This is a pivotal moment in our journey toward gaining regulatory approval. It aligns with our vision of empowering healthcare professionals with transformative technology for VT care." His sentiments are echoed by Dr. Vivek Reddy, Director of Electrophysiology at Mount Sinai Health System, who noted the importance of this breakthrough technology in addressing complex, life-threatening arrhythmias.

About Field Medical Inc.

Founded in 2022, Field Medical Inc. is dedicated to advancing next-generation pulsed field ablation technologies tailored to meet the intricate demands of modern cardiac care. Under the leadership of Dr. Mickelsen, the company innovates continuously, refining its groundbreaking solutions. With products like the FieldForce™ Catheter and FieldFlex™ Sheath, Field Medical aims to expand PFA applications, focusing on treating complex conditions such as ventricular arrhythmias. Their commitment is clear: enhancing patient outcomes through innovative techniques that challenge traditional methodologies.

The Technology Behind FieldForce™ Ablation System

The FieldForce™ Ablation System employs a pioneering single-point contact force PFA catheter, which integrates proprietary FieldBending™ technology to administer precise and high-intensity electric fields. Designed to create targeted lesions efficiently, the technology aims to deliver both localized and expansive ablation treatments effectively, which could significantly improve patient care for those facing the dangers of VT.

Frequently Asked Questions

What is the FieldForce™ Ablation System?

The FieldForce™ Ablation System is a pioneering medical device engineered for the treatment of ventricular tachycardia, utilizing advanced pulsed field ablation technology.

What are the implications of FDA's Breakthrough Device Designation?

This designation indicates that the device could provide more effective treatment options compared to currently approved therapies, facilitating quicker access to innovative solutions for patients.

How does the FieldForce™ System enhance patient outcomes?

By employing advanced ablation techniques, the FieldForce™ System aims to deliver more targeted and effective treatments, potentially reducing the risk of sudden cardiac death associated with ventricular tachycardia.

Who leads Field Medical Inc.?

Field Medical Inc. is led by Dr. Steven Mickelsen, a notable pioneer in pulsed field technology and an advocate for innovative cardiac solutions.

What are the future plans for the FieldForce™ Ablation System?

The company aims for regulatory approval to further develop and expand treatment options for patients suffering from ventricular tachycardia, enhancing the overall technology.

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