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BioWorld - Friday, April 17, 2026
Home » Keywords » Sphere-9

Items Tagged with 'Sphere-9'

ARTICLES

Medtronic - Symplicty Spyral HTN

Pulsed field ablation lifts Medtronic Q2 results

Nov. 18, 2025
By Annette Boyle
Medtronic plc posted solid fiscal year second-quarter results led by the cardiovascular business with 9.3% growth. The Affera Sphere-9 pulsed field ablation system tripled the company’s sales in the hot PFA segment and pushed the cardiac ablation solutions unit to 71% growth, a nice uptick from the nearly 50% seen in its Q1.
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Single Shot PVI

Kardium’s Globe PFA system gains FDA approval

Sep. 3, 2025
By Annette Boyle
Kardium Inc.’s Globe pulsed field system received U.S. FDA premarket approval, making it the fourth PFA system in the rapidly expanding market for cardiac ablation for atrial fibrillation. The system’s introducer sheath and mapping software also received clearance.
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Boston Scientific Farapulse PFS system

UK’s NICE recommends pulsed field ablation to treat atrial fibrillation

July 10, 2025
By Shani Alexander
The U.K.’s National Institute for Health and Care Excellence (NICE) recommends the use of pulsed field ablation as an option to treat NHS patients with atrial fibrillation. NICE said evidence shows the procedure reduces atrial fibrillation and its symptoms, increases quality of life in the short term and raises no major safety concerns.
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Farawave system

Boston Sci charges ahead with AVANT GUARD PFA trial

Nov. 12, 2024
By Annette Boyle
Boston Scientific Corp. resumed enrollment in the AVANT GUARD trial of the Farapulse pulse field ablation (PFA) system after a pause reported in October “to assess a few unanticipated observations.” The trial aims to expand the indications for the market-leading PFA system to include a new population, drug-naïve patients with persistent atrial fibrillation.
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VAripulse

​FDA approval of J&J’s Varipulse ramps up PFA competition

Nov. 7, 2024
By Annette Boyle
Almost a year after U.S. FDA approval of the first pulsed field ablation device for treatment of atrial fibrillation, Johnson & Johnson secured FDA approval for its Varipulse system, intensifying competition in the rapidly growing market.
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