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# Breakthrough Status for Ventricular Tachycardia Ablator
- URL: https://www.fdaweb.com/breakthrough-status-for-ventricular-tachycardia-ablator/
- Published: 2024-12-05T12:00:00.000Z
- Updated: 2026-09-14T14:48:38.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158315

FDA has granted Field Medical a breakthrough device designation its FieldForce Ablation System for treating sustained monomorphic scar-related ventricular tachycardia (VT). The device was also accepted into the agency’s Total Product Life Cycle Advisory Program (TAP), according to the company.

Field Medical says the device is the first pulsed field ablation system specifically designed for ventricular arrhythmia ablation. Catheter ablation has been shown to be superior to medical therapy in patients at risk of sudden cardiac death from ventricular tachycardia, it says, which is responsible for about 450,000 deaths annually in the U.S., according to the company. “Current pharmacological therapies are limited in efficacy, with 30-50% of patients with VT not responding well to traditional drug treatments,” it notes.

The TAP pilot was launched in 2023 under the MDUFA 5 reauthorization to help spur faster development of high-quality, safe, effective, and innovative medical devices. An FDA [notice](https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-expansion-total-product-life-cycle-advisory-program?ref=fdaweb.com) says TAP encourages early, frequent, and strategic communications between breakthrough device developers, CDRH, and others such as patient advocates, physician professional societies, and payers to make the path for innovative devices of public health importance to market and patient access faster, more predictable, and more transparent.