Affera, Inc. Announces Successful First-In-Human Use of SpherePVI Circumferential Pulmonary Vein Isolation Device Using Pulsed Field Energy

WATERTOWN, MA – Affera, Inc., a private medical device company focused on innovative cardiac arrhythmia treatment solutions, announced today first-in-human use of its circumferential Pulmonary Vein Isolation (PVI) Pulsed Field Ablation (PFA) catheter, SpherePVI™. The work was conducted as part of a multi-center first-in-human study designed to evaluate the safety and effectiveness of the SpherePVI catheter and Affera system in patients suffering from atrial fibrillation (AFIB). The first patients were successfully treated at Vilnius University Hospital in Lithuania (PI: Gediminas Rackauskas) joined by Vivek Reddy, M.D., Director of Cardiac Arrhythmia Services for Mount Sinai Health System and Elad Anter, M.D., Associate Section Head of Electrophysiology for Cleveland Clinic.

“PVI is the cornerstone of catheter ablation therapy for patients with atrial fibrillation. Circumferential ablation catheters, also known as ‘single-shot’ catheters, have been developed to simplify the approach for PVI, allowing a rapid and effective ablation strategy that is particularly suitable for patients with paroxysmal atrial fibrillation,” commented Dr. Elad Anter. “The SpherePVI enables performance of circumferential PVI with minimal catheter manipulation and lesion applications. I am glad to report that a first group of patients was treated successfully with this new catheter, achieving PVI with ease and an unprecedently short procedure time. I look forward to future work with this device and reporting longterm patient outcomes.”

SpherePVI is a novel 8F over-the-wire multi-segment lattice tip catheter designed to efficiently deliver circumferential pulmonary vein isolation. The catheter is integrated with the Affera system which includes the Prism-1™ mapping and HexaGEN™ ablation system, as well as the Sphere9™ focal ablation and mapping catheter. Designed to optimize procedural efficiency and efficacy across a broad range of cardiac arrhythmias, the Affera system has been used to treat over 275 patients.

"Our team designed the SpherePVI catheter from the ground up to deliver on the promise of PFA therapy in a true ‘single-shot’ form factor,” stated Doron Harlev, CEO and founder of Affera. “With an estimated $1B in annual revenue, the ‘single-shot’ device segment has grown significantly over the last decade. This new catheter complements the company’s Sphere9, providing a complete range of tools for mapping, ‘single-shot’ ablation for patient with paroxysmal atrial fibrillation, and focal ablation for patients with persistent atrial fibrillation, which often require tailored ablation with additional lesion sets. This latest addition to our portfolio highlights our ongoing commitment to delivering innovative solutions for electrophysiologists and cardiac arrhythmia patients.”

AFIB, which is an irregular heartbeat, is a condition that can lead to blood clots, stroke, heart failure and other heart-related complications and is the fastest growing EP market segment expected to reach $10 billion worldwide in 2025. With an estimated 37 million people currently living with this condition, 1 in 4 adults over 40 is at risk of developing AFIB in their lifetime. Affera, focused on developing comprehensive solutions for the electrophysiology market, offers superior focal and ‘single-shot’ ablation options with integrated mapping.

About Affera, Inc.

Affera is a medical technology company dedicated to delivering unrivaled innovative solutions to address the rapidly growing cardiac arrhythmia market. Affera is developing a comprehensive integrated platform to efficiently deliver durable therapy for a broad set of cardiac arrhythmia patients.