First look: Medtronic’s Sphere-360 pulsed field ablation catheter design has some new tricks

The investigational Medtronic Sphere-360 pulsed field ablation and mapping catheter uses nitinol for a feature that’s unique within Medtronic’s PFA device portfolio.

The Medtronic Sphere-360 pulsed field ablation catheter is adjustable, allowing it to take different shapes inside a patient. [Illustration courtesy of Medtronic]

Medtronic recently offered a first look at its Sphere-360 pulsed field ablation (PFA) and mapping catheter, an investigational device with some design features that are new for the world’s largest device manufacturer.

In an interview with Medical Design & Outsourcing, Tim Laske, VP of research and business development for Medtronic Cardiac Ablation Solutions, discussed the Sphere-360’s design and features.

The large-lattice, over-the-wire PFA Sphere-360 catheter — which Medtronic purchased through its acquisition of Affera — is investigational in the EU …

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Power tips for designing pulsed field ablation systems

An engineer develops the pulsed waveform output for a PFA system. [Photo courtesy of Minnetronix Medical]

An engineer experienced with radiofrequency (RF) ablation systems might wonder what all the fuss is about when looking at the design of a pulsed field ablation (PFA) system.

Compared to an RF ablation generator, a PFA generator is going to look much less complicated, perhaps with only a tenth as many parts. But the seemingly simpler schematics can be deceiving.

“The difference is that in a PFA power supply, the way that those components are being used is just so different, and they’re being stressed to the limits of what their ratings are in a way that just isn’t obvious to most engineers,” said Dan Friedrichs, an engineer at Minnetronix Medical. “… There’s more complexity than meets the eye.”

Friedrichs leads development engineering efforts at M…

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Abbott bets on balloons in pulse field ablation battle

The Abbott Volt aims to beat first-generation pulse field ablation (PFA) systems with its balloon-in-basket design and other features.

The Abbott Volt pulse field ablation (PFA) catheter features a balloon-in-basket design and eight electrode splines. [Image courtesy of Abbott]

One component stands out as unique when you compare the Abbott Volt against competing pulse field ablation (PFA) systems from Medtronic and Boston Scientific.

The Volt cardiac ablation catheter has a balloon, something you won’t see on Medtronic’s PulseSelect PFA catheter — the first of its kind approved by the FDA — or the Farawave catheter in the Farapulse PFA system that Boston Scientific expects will soon win approval.

The Abbott Volt’s balloon-in-basket is designed to support the efficient deployment of energy into the tissue during cardiac ablation to treat atrial fibrillation (AFib). That energy creates le…

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What’s so special about pulsed field ablation? Medtronic EVP Sean Salmon explains

The Medtronic PulseSelect Pulsed Field Ablation (PFA) System is designed to treat paroxysmal and persistent atrial fibrillation (AFIb). [Image courtesy of Medtronic]

Medtronic’s PulseSelect Pulsed Field Ablation (PFA) System — which won the first FDA approval for PFA to treat atrial fibrillation (AFib) — is just the start of a wave of new PFA devices expected to hit the market.

Medtronic is lining up another PFA cardiac ablation system for approval, while competitor Boston Scientific anticipates approval of its Farapulse PFA system sometime in 2024. Meanwhile, Johnson & Johnson’s Biosense Webster is testing its ThermoCool SmartTouch SF system for both PFA and radiofrequency ablation.

Medtronic EVP and Cardiovascular President Sean Salmon recently discussed PFA technology in an interview with Medical Design & Outsourcing before the world’s largest medical device manufacturer anno…

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Boston Scientific’s Farapulse PFA system is poised for FDA approval, analysts say

The Farapulse system’s Farawave single-shot ablation catheter expands inside the patient to deliver energy for treating AFib. [Image courtesy of Boston Scientific]

Boston Scientific’s Farapulse pulsed-field ablation (PFA) system likely hit its primary endpoints, according to Needham analysts who say that means the technology is poised for FDA approval.

Boston Scientific has already said it expects FDA approval of Farapulse next year, but has not yet shared results from its ADVENT pivotal trial.

That data is set for release on Aug. 27 at the 2023 European Society of Cardiology (ESC) Congress. The device developer started that trial in March 2021 and stopped enrolling patients in June 2022.

Based on the trial’s adaptive design with a varying number of possible patients — 350, 450, 550, 650 or 750 — and the timing of enrollment, the Needham analysts say they suspect Boston Scientifi…

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