Field Medical Innovates with New FDA Breakthrough Device Designation

Field Medical Achieves FDA Milestones for Innovative Therapy

Field Medical® Inc. has recently gained significant recognition with its FieldForce™ Ablation System receiving FDA's Total Product Life Cycle Advisory Program (TAP) Pilot acceptance along with the Breakthrough Device Designation. This dual recognition signifies an important step in enhancing treatment options for patients suffering from ventricular tachycardia (VT).

About the FieldForce™ Ablation System

The FieldForce™ Ablation System is a pioneering advancement in the treatment of ventricular arrhythmias. As the first and only contact force pulsed field ablation (PFA) system, it is engineered specifically to address the life-threatening risk posed by VT. This innovative system aims to provide better outcomes for individuals at risk of sudden cardiac death due to ventricular tachycardia.

FDA Recognition and Its Importance

The FDA's TAP Pilot and Breakthrough Device Designation are reserved for devices believed to deliver more effective treatments in comparison to existing therapies. By expediting the approval process for innovative treatments, the FDA aims to ensure that patients can access groundbreaking solutions sooner. The FieldForce™ Ablation System exemplifies this commitment to innovation in clinical care.

The Future of VT Care

Dr. Steven Mickelsen, CEO of Field Medical, expressed that these FDA milestones mark a pivotal moment for the company, enhancing the vision of delivering accessible VT care. This new technology embodies a next-generation tool designed specifically for electrophysiologists, allowing for more effective and timely intervention in treating ventricular tachycardia.

Understanding Ventricular Tachycardia and Its Risks

Ventricular tachycardia (VT) represents a dangerous heart condition that can lead to sudden cardiac death (SCD). SCD, accounting for approximately 450,000 deaths annually in the United States, is frequently associated with VT. Research indicates that standard pharmacological treatments have limitations, with a significant number of patients showing inadequate responses. The scientific community recognizes the necessity for innovative options like the FieldForce™ Ablation System to fill this urgent gap.

About Field Medical® Inc.

Established in 2022, Field Medical is committed to revolutionizing cardiac ablation through state-of-the-art pulsed field technologies. The company, driven by the visionary leadership of Dr. Steven Mickelsen, continues to expand its portfolio to address the complexities surrounding ventricular arrhythmias. Field Medical's advancements include the FieldForce™ Catheter and FieldFlex™ Sheath, which aim to transform cardiac care for patients worldwide.

Insights from Leading Experts

Dr. Vivek Reddy, Director of Electrophysiology at a prominent health system, remarked on the breakthrough nature of this technology. He noted that the FDA's recognition underscores the urgent need for improvements in managing life-threatening VT. Such innovations could redefine treatment protocols and enhance outcomes for both healthcare professionals and patients alike.

FieldForce™ Ablation System Features

The FieldForce Ablation System employs a single-point contact force PFA catheter that utilizes unique FieldBending™ technology. This advanced design facilitates the delivery of precise high-intensity electric fields, catering to the creation of targeted lesions alongside large volume transmural lesions in the heart's ventricles.

Looking Ahead

Ongoing research and development will continue to play a critical role in the evolution of the FieldForce™ technology. As the company strives towards regulatory approval, it remains focused on innovation that can alter the landscape of cardiac care, ultimately saving lives.

Frequently Asked Questions

What is the significance of the FDA Breakthrough Device Designation?

The Breakthrough Device Designation signifies that the product offers a more effective treatment option than existing therapies and expedites patient access to the innovation.

How does the FieldForce™ Ablation System work?

The system utilizes a pulsed field ablation technique to precisely target and treat ventricular tachycardia, helping to create effective lesions within the heart.

Who leads Field Medical, and what are its goals?

Field Medical is led by Dr. Steven Mickelsen, with the goal of advancing pulsed field ablation technologies to improve cardiac care and patient outcomes.

Why is there a need for innovative solutions in VT treatment?

Current medications are often ineffective for many patients, with a significant percentage failing to respond adequately, highlighting the need for alternative approaches like the FieldForce™ system.

When was Field Medical founded?

Field Medical was founded in 2022 and has quickly become a leader in the development of next-generation cardiac ablation technologies.

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