Boston Scientific Secures FDA Approval for FARAPULSE PFA System's Expanded Indication in Persistent Atrial Fibrillation, Challenging Medtronic's Market Dominance

Boston Scientific Announces FDA Approval of Its PFA Product---FARAPULSENew Indications, namelyFARAPULSECanTreatment of drug-refractory, symptomatic persistentAtrial fibrillation. Prior to this, only Medtronic's PFA product (Sphere-9 andPulseSelect) is approved for treatmentPersistent Atrial Fibrillation, Breaking Medtronic's Monopoly.

Executive Evaluation

"With clinical evidence and global commercialization experience, this update will drive us to reshape the future of atrial fibrillation treatment through safe and effective ablation technology. We look forward to validating the system's efficacy in new clinical trials for patients requiring repeat ablations and those with complex arrhythmias — currently, such procedures still predominantly rely on thermal ablation technology."

---Brad Sutton  Chief Medical Officer of Boston Scientific Atrial Fibrillation Solutions

FDA ApprovalFARAPULSEThe new indication is based on the ADVANTAGE AF clinical study conducted by Boston Scientific. The study showed no reports of stroke, pulmonary vein stenosis, atrial-esophageal fistula, or major access complications, with a symptomatic atrial fibrillation recurrence-free rate of 85.3%. It was also found in the study that once doctors had performed three or more procedures,FARAPULSEThe rate of persistent atrial fibrillation symptom non-recurrence after treatment increased to 91.4%. It can be said thatFARAPULSEIt is an extremely easy-to-use ablation technology, and this ease of use also makesFARAPULSEBecoming the PFA product with the highest market sales.

In addition, Boston Scientific also indicated applicability for persistent atrial fibrillation.FARAPULSECE, NMPA, and other approvals will also be obtained in the coming months.Approved by PMDA. Meanwhile, Boston Scientific launched a new clinical study.ReMATCH IDE: This study will recruit approximately 375 patients across 40 centers in the Asia-Pacific region, primarily evaluating the safety and efficacy of the FARAWAVE PFA catheter for posterior left atrial ablation and pulmonary vein isolation in patients with persistent atrial fibrillation (who have experienced recurrence after previous treatment with PFA/radiofrequency/cryoablation catheters). It will also assess the adjuvant therapeutic effects of the FARAPOINT PFA catheter for cavotricuspid isthmus ablation and left atrial mitral isthmus ablation within the same patient population.

Biosense Webster will make a full-scale push in the persistent atrial fibrillation field, further solidifying its leadership position in the atrial fibrillation sector.

• FARASTAR：Using bipolar and biphasic waveforms as well as proprietary pulses. The interface is simple to operate, allowing for isolation of the pulmonary vein vestibule with just three buttons.

• FARADRIVE: is a 13Fr distal deflectable sheath, which can betterFARAWAVE navigates to the vestibules of each pulmonary vein.

• FARAWAVE: It is an ablation catheter with a diameter of 12Fr. Its distal end features a unique flower-shaped design, with a total of 5 "petals," eachUp"Petal"Configured with 4 electrodes. The slider button on the handle can control whether the distal end is in the "bud" or "full bloom" state. When5 "Petals"Fully opened, it presents as a flat petal shape; if partially expanded, it appears as a three-dimensional basket shape, with the basket diameter adjustable via catheter expansion and contraction.