pulsed-field ablation Archives - Medical Design Sourcing

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…

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…

Applications of electrical energy in medicine: RF ablation, pulsed-field ablation and electroporation

Learn about new and promising applications of energy-based medical systems and the challenges of developing them.

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

Daniel Friedrichs, Minnetronix Medical

While modern medicine is awash in high-tech electronics from large surgical robots to tiny implanted sensors, there are several applications where electrical energy is directly applied to a patient to ablate tissue, convey drugs, or achieve other clinical effects.

Given the obvious concerns with applying electricity to humans, developing these tools safely and effectively is crucial.

This article briefly reviews these applications of electrical energy in medicine and new opportunities to refine existing technology such as radiofrequency (RF) ablation or realize radical improvements using new energy modalities such as pulsed-field ablation (PFA…

Why Affera’s cardiac ablation technology is worth $1B to Medtronic

Affera’s Sphere-9 mapping and ablation catheter [Photo courtesy of Affera]

Affera started in 2014 with a simple goal that paid off when Medtronic (NYSE:MDT) bought the company for up to $1 billion this year.

Achieving that goal, however, took some unconventional and sometimes difficult design choices, Affera founder and CEO Doron Harlev said.

Newton, Massachusetts–based Affera’s system diagnoses, maps and treats heart arrhythmias with ablation. It’s a process that scars heart tissue to interrupt errant signals. Affera’s system uses both radiofrequency (RF) ablation — as well as the non-thermal pulsed-field ablation tech that has been generating buzz in medtech.

Complex arrhythmias like atrial fibrillation and ventricular tachycardia can require an electrophysiologist to perform more extensive ablation. But Harlev and his team at Affera thought a larger ablation tip could ma…

What is pulsed-field ablation? Here’s what you need to know

Top experts at Boston Scientific, Medtronic and Acutus Medical shared insights about pulsed-field ablation’s potential at DeviceTalks Boston.

Part of the Farapulse pulsed-field ablation system, the Farawave single-shot catheter is designed to create durable and circumferential lesions. [Image courtesy of Boston Scientific]

Pulsed-field ablation is a non-thermal method for cardiac ablation that has the potential to positively disrupt the way atrial fibrillation is treated.

PFA’s roots go back to the dc ablation tech of the 1980s. These days, PFA generally involves high-voltage electric pulses from a catheter-delivered electrode or electrodes, delivered each at a tiny fraction of a second. Its potential advantages versus radiofrequency ablation or cryoablation include the characteristic that heart muscle tissue can be especially susceptible to it, while other types of surrounding tissue are injury resistant.

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