Acutus Medical today announced it submitted pivotal clinical data of its AcQBlate force-sensing ablation catheter to the FDA for premarket approval.
The Carlsbad, California-based company submitted data from the AcQForce Flutter trial, a prospective, multicenter, non-randomized study approved under an FDA investigational device exemption (IDE).
“Submission of the AcQBlate Force PMA application represents a major milestone in our evolution as we expand our portfolio in the United States to include an integrated mapping and therapy system,” President and CEO David Roman said in a news release. “The demonstrated performance of the AcQBlate Force in the US IDE study, along with strong commercial adoption in Europe through our direct sales force and distribution partner, Biotronik, underscores our confidence in our growth strategy for 2023 and beyond.”
The AcQForce Flutter trial was conducted in right atrial typical flutter patients presenting for a de novo percutaneous cardiac ablation of the Cavo-tricuspid isthmus (CTI). It enrolled 110 patients at 21 sites globally and was designed to evaluate the safety and efficacy of the AcQBlate Force sensing ablation catheter and system in treating right atrial typical flutter.
Catheter ablation procedures to treat right atrial flutter consists of 30% of ablation procedures in the U.S. and are expected to reach 200,000 by 2025, according the company. Primary endpoints were acute procedural success defined as bidirectional CTI block and freedom from serious adverse events seven days after the procedure.
AcQBlate uses a unique gold tip electrode, low flow irrigation and contact force sensing capability. The irrigated gold tip has 4x thermal conductivity compared to platinum catheters. Contact force also allows physicians to see in real-time how much force is being applied to the heart from the catheter tip during ablations.