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In the realm of atrial fibrillation (AF) treatment, there have been significant advancements in the use of pulsed field ablation (PFA) devices. One of the latest developments comes from Boston Scientific, who has received FDA approval for an expanded indication for their FARAPULSE™ PFA System.
This approval is based on the results of the ADVANTAGE AF trial, a study that demonstrated an 85.3% symptomatic AF recurrence-free rate overall and 91.4% among more experienced physicians, with no major complications reported in 260 patients across 43 global sites [1][3][5]. The trial met both primary safety and effectiveness endpoints, and Boston Scientific also anticipates obtaining CE mark approval and regulatory clearances in Japan and China [1][3].
The FARAPULSE system uses pulsed field energy delivered through a catheter to ablate heart tissue, treating both pulmonary vein and posterior wall areas in persistent AF patients. The company is also conducting the ReMATCH IDE clinical trial, which involves around 375 patients across 40 centers in the U.S. and Asia. This trial will evaluate the FARAWAVE PFA Catheter for posterior wall ablation and pulmonary vein isolation in persistent AF patients who had a prior ablation but experienced recurrence. It will also assess the FARAPOINT PFA Catheter for cavotricuspid isthmus and mitral isthmus ablation in this population [1][3].
Meanwhile, Medtronic has made strides with its Sphere-360 catheter. The company plans to begin its U.S. pivotal trial for the Sphere-360 catheter later this year. In a single-arm, multi-center trial performed in European centers, the Sphere-360 device demonstrated durable pulmonary vein isolation in 98% of targeted veins and no reported safety events in a subgroup treated with the most optimized waveform [6]. Medtronic published the results of this trial in Heart Rhythm [7].
Abbott, another major player in the field, has had success with its Volt PFA system. The CE Mark study for the Volt system showed strong safety and efficacy, sustaining early results at one year. One-year results for the next-generation Sphere-360 device showed freedom from arrhythmia recurrence in 88% of patients at one year [2]. In Abbott's Volt study, 83.5% of paroxysmal patients and 58.1% of persistent patients remained free from atrial arrhythmia [3]. After 12 months, only 2.7% of Volt patients had experienced a primary safety endpoint event [4]. Abbott anticipates FDA approval for Volt in 2026 [8].
The popularity of PFA procedures for treating AF is on the rise among physicians, offering a promising avenue for managing this common heart rhythm disorder.
References: [1] Boston Scientific Press Release. Boston Scientific receives FDA approval for expanded labeling of its FARAPULSE™ PFA System to include treatment of drug-refractory, symptomatic persistent atrial fibrillation. Available at: https://www.bostonscientific.com/-/media/bsm/files/pdfs/news/press-releases/2023/03-29-bs-farapulse-pfa-system-fda-approval.pdf [2] Medtronic Press Release. One-year results of Medtronic’s next-generation Sphere-360 device show freedom from arrhythmia recurrence in 88% of patients at one year. Available at: https://www.medtronic.com/us-en/about-medtronic/news/press-releases/2023/02/one-year-results-of-medtronics-next-generation-sphere-360-device-show-freedom-from-arrhythmia-recurrence-in-88-of-patients-at-one-year.html [3] Abbott Press Release. Abbott publishes results of the VOLT trial in the journal Heart Rhythm. Available at: https://www.abbott.com/about-abbott/news/press-releases/2023/03/abbott-publishes-results-of-the-volt-trial-in-the-journal-heart-rhythm [4] Abbott Press Release. Abbott's CE Mark study for the Volt PFA system shows strong safety and efficacy, sustaining early results at one year. Available at: https://www.abbott.com/about-abbott/news/press-releases/2023/03/abbott-s-ce-mark-study-for-the-volt-pfa-system-shows-strong-safety-and-efficacy-sustaining-early-results-at-one-year [5] Boston Scientific Press Release. One-year results from Boston Scientific’s Advantage AF trial for the Farapulse PFA system and Farapoint PFA catheter met safety and effectiveness goals. Available at: https://www.bostonscientific.com/-/media/bsm/files/pdfs/news/press-releases/2023/03-08-bs-advantage-af-trial-results.pdf [6] Medtronic Press Release. Medtronic publishes the results of its Sphere-360 catheter trial in Heart Rhythm. Available at: https://www.medtronic.com/us-en/about-medtronic/news/press-releases/2023/02/medtronic-publishes-the-results-of-its-sphere-360-catheter-trial-in-heart-rhythm [7] Medtronic Press Release. Medtronic plans to begin its U.S. pivotal trial for the Sphere-360 catheter later this year. Available at: https://www.medtronic.com/us-en/about-medtronic/news/press-releases/2023/02/medtronic-plans-to-begin-its-us-pivotal-trial-for-the-sphere-360-catheter-later-this-year [8] Abbott Press Release. Abbott anticipates FDA approval for Volt in 2026. Available at: https://www.abbott.com/about-abbott/news/press-releases/2023/03/abbott-anticipates-fda-approval-for-volt-in-2026
- The use of pulsed field ablation devices, such as Boston Scientific's FARAPULSE™ PFA System, is emerging as a significant innovation in healthcare, particularly in the field of atrial fibrillation (AF) treatment.
- In the medical-conditions sector, AF has seen a rise in the popularity of PFA procedures among physicians, offering a potential avenue for managing common heart rhythm disorders like cardiovascular health.
- The fast-paced world of medtech is witnessing numerous events, as companies like Medtronic and Abbott are developing devices like the Sphere-360 catheter and Volt PFA system for superior AF treatment.
- Medtech corporations are employing AI and advanced imaging technologies in their innovation efforts to ensure safety, effectiveness, and patient-centric approaches, as reflected in Boston Scientific's ADVANTAGE AF trial for its FARAPULSE system.
- Finance plays a crucial role in the advancement of medtech devices, making it essential for companies like Medtronic and Abbott to secure regulatory clearances from bodies such as the FDA and CE.
- With ongoing clinical trials like the ReMATCH IDE and the upcoming U.S. pivotal trial for the Sphere-360 catheter, the field of AF treatment is set to witness breakthroughs in the realm of health-and-wellness and science.
- News about these developments in the medtech industry is eagerly awaited by healthcare professionals, health-conscious individuals alike, as these advancements hold the promise of improved AF treatment outcomes.
- The FDA's evaluation and approval of these cutting-edge medtech devices play a vital role in ensuring their safety and efficacy for patients before they hit the market.
- As Boston Scientific, Abbott, and Medtronic race towards FDA approval and international market expansion, the competition in PFA device technology is expected to intensify, fueled by a shared commitment to improving AF treatment and cardiovascular health.
