Field Medical, Founded by 'Father of PFA' Steven Mickelsen, Secures FDA Breakthrough Device Designation for FieldForce™—the First and Only PFA System Dedicated to Ventricular Arrhythmia

Source: Heart Future

The FieldForce™ system utilizes proprietary FieldBending™ technology to deliver targeted, transient, high-intensity electric fields through a single-point contact force PFA catheter. FieldBending™ technology predictably concentrates energy around the catheter, reducing unwanted far-field effects. This technology allows power to be applied more accurately and focused on the target tissue, enhancing treatment precision.

In 2022, Field Medical and CardioNXT announced a strategic partnership aimed at delivering a first-of-its-kind pulsed field ablation (PFA) therapy integrated with 3D mapping and navigation.

The two companies plan to develop a dedicated system that integrates PFA, contact force sensing, electromagnetic navigation, and AI mapping to enhance the safety and efficacy of cardiac catheter ablation procedures while reducing the use of X-rays during surgery.

Field Medical had already initiated its first-in-human study of the FieldForce pulsed field ablation (PFA) system in May 2024. This study is known as the Ventricular Catheter Ablation Study (VCAS).The VCAS study began at Na Homolce Hospital in Prague, Czech Republic.Plan to recruit at up to 5 locations globallyUp to 60 patients。

Field Medical aims to demonstrate the safety and performance of its PFA system through this study, particularly addressing the limitations of existing PFA and radiofrequency (RF) ablation systems, including offering a more time-efficient treatment option for ventricular arrhythmias.

Preliminary data shows that FieldForce has already demonstrated significant promise in the early stages of the trial, with the potential to revolutionize traditional catheter ablation for complex ventricular arrhythmias, possibly surpassing current standards of care.

Arrhythmia is a change in the heart's beating frequency and rhythm caused by abnormal sinus node excitation or conduction pathway disorders. Based on the different sites of origin, arrhythmias are divided into four categories: sinus arrhythmia, atrial arrhythmia, ventricular arrhythmia, and junctional arrhythmia.

Ventricular arrhythmia is a common clinical arrhythmia, mainly including ventricular premature beats, ventricular tachycardia, ventricular flutter, and ventricular fibrillation. Ventricular arrhythmias often occur in patients with well-diagnosed structural heart disease and ion channel disorders, but they are not uncommon in people with normal cardiac structure. The clinical manifestations of ventricular arrhythmias vary greatly; patients may be asymptomatic, experience palpitations or syncope, or even suffer sudden cardiac death (SCD). In many patients with underlying heart diseases, ventricular arrhythmias often coexist, while in some patients with heart abnormalities, ventricular arrhythmias may be the earliest or only clinical manifestation.

According to HQMS data, in 2023, the number of hospitals in China treating hospitalized patients with arrhythmia was 7,583; the number of visits by hospitalized patients with arrhythmia reached 11.13 million. The total number of catheter ablation procedures was 342,000, including 119,000 cases of paroxysmal supraventricular tachycardia, over 63,000 cases of premature ventricular contractions, and nearly 13,000 cases of ventricular tachycardia.

In terms of device therapy, compared with optimal antiarrhythmic drug therapy, implantable cardioverter-defibrillators (ICDs) are more effective in the secondary prevention of survivors of cardiac arrest or patients who have experienced sustained VT/ventricular fibrillation (VF) or syncope induced by VT, particularly in the long-term reduction of mortality in heart failure patients.

Although the benefit of ICD in reducing mortality in heart failure patients is certain, ICD therapy cannot prevent the recurrence of arrhythmia. Repeated VT/VF episodes and ICD shock treatments may further deteriorate cardiac function, leading to hospitalization, cardiac-related death, and all-cause mortality.

The major players in the global ICD market include Medtronic, Boston Scientific, Biotronik, Abbott (after acquiring St. Jude Medical), and other companies. These companies possess strong competitiveness in terms of technological innovation, product quality, and global distribution networks. Currently, there are 13 imported ICD products approved for use in China, while only one domestically produced ICD product, developed by CH pacemaker, has been approved for marketing.

To reduce the burden of symptomatic arrhythmias, in addition to emphasizing optimal medication therapy, catheter ablation has been proven successful in treating ventricular arrhythmias and preventing recurrence in heart failure patients. Some studies have also confirmed benefits such as reduced hospital admissions, prolonged VT/VF-free survival time, and decreased mortality.

However, achieving transmural injury remains a challenge, especially when targeting intramural and subendocardial lesions, accessing critical epicardial sites, and approaching targets near vital structures. Additionally, precisely and dynamically mapping hemodynamically unstable ventricular arrhythmias, polymorphic premature ventricular contractions, and ventricular fibrillation triggers in high spatiotemporal resolution also presents significant difficulties.

In order to target hemodynamic instability and polymorphic ventricular arrhythmias, substrate modification is increasingly being performed, but this approach carries the risk of extensive ablation and lacks sufficient specificity, potentially leading to the unintentional loss of myocardial cells in already damaged ventricles.

HQMS Report: In 2023, catheter ablation accounted for 97.3% of arrhythmia ablation procedures, including 326,000 cases of radiofrequency ablation (93.9%), 12,000 cases of cryoablation (3.4%), and 60 cases of pulse ablation; surgical ablation accounted for 9,256 cases (2.7%).

Although radiofrequency ablation and cryoablation have been clinically applied for a relatively longer time, pulse ablation is considered a clinical "newcomer." However, for thicker ventricular walls, traditional thermal ablation techniques may not achieve the required ablation depth. Innovative PFA technologies (such as Field Medical's FieldForce™ Ablation System) enable energy to penetrate deeper into tissues, achieving a greater range of ablation.

As of now, the National Medical Products Administration (NMPA) has approved innovative product registration applications for cardiac pulse field ablation systems from five companies: Jinjiang Electronics, Denovo Electrophysiology, Medtronic, Boston Scientific, and Shanghai Hongtong. A number of other China-based companies, including Shangyang Medical, Beixing Medical, Jianhu Medical, and Ruidi Biotech, are also developing innovative pulsed-field ablation products. Who will emerge as the winner among market competitors will ultimately depend on the overall effectiveness of the companies' product capabilities, supporting services, and promotional efforts.

Field Medical is an innovative company focused on the field of pulsed electric field catheter ablation. Founded by Dr. Steven Mickelsen in 2022, the company is developing a patented technology called FieldBending, which aims to concentrate therapeutic effects and reduce the harmful far-field effects associated with first-generation PFA technology.

Field Medical Plans to Expand the Indications of Pulsed Field Ablation (PFA) Beyond Atrial Fibrillation Treatment by Addressing More Challenging Ventricular Arrhythmias and Common Procedures Such as Supraventricular Tachycardia (SVT) That Require Minimal Sedation. The Company Completed Its Seed Financing Round in September 2023, Raising $14 Million.