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BioWorld - Sunday, May 24, 2026
Home » Affera

Articles Tagged with ''Affera''

Medtronic Hugo platform

Medtronic sees first cases with Hugo robotic platform

Feb. 19, 2026
By Shani Alexander
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Medtronic plc this week reported that the first commercial surgical cases using its Hugo robotic-assisted surgery system have been completed in the U.S. Hugo is expected to be a key growth driver for the company, especially with opportunities in the underpenetrated U.S. soft tissue surgical robotics market. The company also posted third-quarter fiscal year 2026 organic revenues of $9.02 billion, up 6% year‑on‑year.
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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

FDA greenlights Boston Sci’s Farapulse for persistent AF

July 7, 2025
By Annette Boyle
Boston Scientific Corp. gained a second U.S. FDA approval for its Farapulse pulsed field ablation catheter, expanding its use into drug-refractory, symptomatic persistent atrial fibrillation (AF) in addition to its existing approval for paroxysmal AF. The expanded indication marks the first of several regulatory approvals the company expects in the coming months.
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Single Shot PVI

Kardium beats expectations with $250M haul

July 2, 2025
By Annette Boyle
Kardium Inc. raised C$340 million (US$250 million) in an oversubscribed financing round to support commercialization of its Globe pulsed field ablation system for atrial fibrillation. Notably, the financing included an equity investment by an unnamed leading strategic investor. Kardium could receive U.S. FDA approval as early as this quarter and plans to launch Globe in the U.S. this year.
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Hands holding torn contract

Medtronic aims to sweeten appeal by unloading diabetes unit

May 21, 2025
By Annette Boyle
Medtronic plc revealed plans to spin off its underperforming diabetes unit as a separate public company during its fourth quarter 2025 earnings call May 21. The company expects to complete the separation within 18 months.
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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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Medtronic - Affera Mapping and Ablation System

Medtronic’s Affera PFA snags FDA approval

Oct. 25, 2024
By Annette Boyle
Medtronic plc added a second U.S. FDA pulsed field ablation (PFA) device approval to its scorecard with the agency’s greenlight for its Affera mapping and ablation system with the Sphere-9 catheter. Affera brings the first radiofrequency/PFA device to the cardiac ablation market and ups the ante in the PFA competition.
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Medtronic - Affera Mapping and Ablation System

FDA OKs study of Medtronic’s Affera in ventricular tachycardia

Oct. 17, 2024
By Annette Boyle
Medtronic plc received U.S. FDA approval to undertake an early feasibility study of its dual-energy Affera cardiac ablation system in sustained ventricular tachycardia. Affera combines both radiofrequency and pulsed field ablation technologies in the Sphere-9 catheter along with high-density mapping.
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