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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Medtronic execs: renal denervation for AFib could be on the horizon

The Medtronic Symplicty Spyral renal denervation (RDN) catheter delivers radiofrequency energy from four electrodes to ablate nerves in the renal arteries and treat high blood pressure. The nitinol-based device expands in a spiral pattern inside the blood vessel. [Image courtesy of Medtronic]

Medtronic renal denervation leaders Jason Weidman and Sean Salmon discuss RDN’s potential to help patients with atrial fibrillation (AFib).

As if treating an epidemic-level condition like hypertension wasn’t enough, renal denervation (RDN) also shows potential for atrial fibrillation (AFib) and other conditions related to high blood pressure.

In interviews with Medical Design & Outsourcing, Medtronic EVP Sean Salmon and SVP Jason Wediman discussed whether their Spyral Symplicity radiofrequency (RF) catheter ablation technology could help AFib patients when paired with cryoablation.

Weidman — pres…

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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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Boston Scientific ramps up Farapulse manufacturing with new site

The Farapulse pulsed-field ablation system’s Farawave catheter (pictured) uses an energy field generated by the Farastar to treat atrial fibrillation. [Image courtesy of Boston Scientific]

Boston Scientific plans to increase production of its Farapulse pulsed-field ablation (PFA) system with a second pulse generator manufacturing site.

“Demand for the platform far exceeds our ability to supply thus far,” Boston Scientific Chair and CEO Mike Mahoney said on yesterday’s earnings call.

He soon after shared that the device developer “just recently received GMED approval for a manufacturing approval to actually manufacture this in Minnesota.”

Paris-based GMED is a notified body designated by France for conformity assessment under the EU Medical Devices Regulation (MDR).

Farapulse Inc.  secured CE mark approval for the system before being acquired by Boston Sci…

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Volta Medical raises $28M for Afib treatment tech

Volta Medical announced this week that it raised $28 million in a financing round for its AI algorithms for treating cardiac arrhythmias.

Marseille, France-based Volta Medical said in a news release that the $28 million, raised in a round led by Gilde Healthcare with participation from existing shareholder Pasteur Mutualité, will help the company establish its VX1 AI software solution as a new standard of care.

VX1 is a machine- and deep-learning algorithm designed to assist operators in the real-time manual annotation of 3D anatomical and electrical maps of the human atria during Afib or atrial tachycardia. The company received FDA clearance for the platform in December 2020.

The company also expects to utilize the funds raised to pursue further R&D activities and begin the rollout of commercial activities across the U.S. and Europe, as the device has CE Mark approval, too.Volta is currently recruiting for an international multicenter trial called T…

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