Field Medical Introduces Groundbreaking Data at AF Symposium
Demonstrating Instantaneous Ablation Through High-Voltage Waveforms and Efficient Point-by-Point Pulsed Field Ablation
Field Medical, Inc., a clinical-stage medical technology company dedicated to advancing pulsed field ablation (PFA) solutions for cardiac arrhythmias, has recently shared remarkable new data stemming from its innovative Field PULSE Clinical Trial. This presentation occurred during a prominent three-day conference focused on atrial fibrillation, marking a significant moment in the world of cardiovascular health.
The Advancement of Pulsed Field Ablation
The Field PULSE trial investigates a novel high-voltage, sub-second pulsed field waveform as administered through the FieldForce™ Ablation System. This unique technology allows for instantaneous ablation using a focal, contact-sensing catheter that provides energy delivery in a point-by-point manner without the extended tissue-catheter contact typically required in other methods.
Immediate Benefits of New Method
Dr. Vivek Y. Reddy, the principal investigator of Field PULSE and an electrophysiologist at Mount Sinai, shared insights on the trial's exciting potential. "Our innovative pulsed field delivery system not only enhances efficiency in the ablation process but also maintains a level of flexibility crucial for physicians, ultimately promoting better patient outcomes," he noted.
Key Findings from the Field PULSE Trial
The data revealed through this trial offer immediate insights into the effectiveness of the FieldForce™ Ablation System:
- Instantaneous Energy Delivery: Lesions achieved in under 200 milliseconds, facilitating rapid point-by-point ablation.
- Procedural Efficiency: Notable median bilateral pulmonary vein isolation time of just 12.5 minutes, with some cases concluding as swiftly as 7.7 minutes.
- PVI Durability: Observed improvements in biphasic pulmonary vein isolation durability, with 94.2% efficacy by vein and 84.6% by patient.
- Safety Outcomes: The trial observed no serious adverse events linked to the device. Evaluations, including brain MRIs, confirmed no emergent cerebral lesions.
These compelling results contribute a significant layer of evidence to Field Medical's advanced high-voltage focal PFA approach, extending its application from ventricular arrhythmias to more complex atrial fibrillation cases. This is the foundation for enhancing treatment efficacy across various heart chambers while prioritizing operational efficiency.
Reinforcing a Platform for Cardiac Solutions
Dr. Steven Mickelsen, the founder and chief technology officer of Field Medical, expressed his perspective on these findings. “The Field PULSE data validates our method of strategically designing focal PFA solutions away from the current methodologies that frequently encounter limitations. By enabling rapid ablation points, we are less susceptible to challenges presented by cardiac motion, establishing a robust framework for managing complex arrhythmias.”
Educational Sessions at the Symposium
The Field PULSE data were spotlighted during the Late Breaking Clinical Trials Session at the AF Symposium. Additionally, Field Medical will feature on Friday, engaging in a significant scientific session focused on the biophysics of PFA.
Key presentations will include one from Dr. Kenneth Ellenbogen titled Maximizing Lesion Depth Using High Voltage PFA Waveform and another during the Case Transmission Session showcasing Dr. Vivek Reddy's findings related to AF ablation using the FieldForce Ablation System.
About Field Medical and Its Technology
The FieldForce™ Ablation System is an investigational device that applies innovative FieldBending™ technology to deliver specifically targeted, high-intensity electric fields for both atrial and ventricular ablation. By focusing on procedural efficiency and tailored patient care, Field Medical strives to empower healthcare professionals with effective tools for combating complex cardiac arrhythmias.
Founded in 2022, Field Medical has quickly positioned itself as a leader in the industry, receiving accolades and recognition for its commitment to enhancing treatment for cardiac conditions. Their achievements reflect the dedication to improving patient outcomes in the field of electrophysiology.
Frequently Asked Questions
What is the FieldForce™ Ablation System?
The FieldForce™ Ablation System is a pioneering contact-sensing system for pulsed field ablation, designed to treat complex cardiac arrhythmias efficiently.
What were the key findings of the Field PULSE trial?
Key findings included instantaneous lesion creation, enhanced procedural efficiency, demonstrated durability of pulmonary vein isolation, and strong safety outcomes.
Who is the principal investigator for the Field PULSE study?
Dr. Vivek Y. Reddy, an electrophysiologist, serves as the principal investigator for this crucial trial.
When and where were the findings presented?
The findings were presented at the Annual International AF Symposium, showcasing significant advancements in cardiac treatment methodologies.
What is the purpose of the Field PULSE trial?
The purpose of the trial is to assess the efficacy and safety of a new high-voltage, pulsed field waveform for treating complex cardiac arrhythmias.
