Medtronic's PulseSelect PFA System Becomes First FDA-Approved Pulsed Field Ablation Platform for Atrial Fibrillation

Dec 14, 2023 16:40 CST Updated 16:40

Medtronic

Medical Device Manufacturer

Source of the article:Heart NotCome;Editor:Liu Xinyi

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Heart Future

On December 13, 2023, Medtronic (NYSE: MDT) officially announced on its website that its subsidiaryPulseSelect Pulsed Field Ablation (PFA) SystemReceived FDA approval for treatmentParoxysmal and Persistent Atrial Fibrillation, becoming the first PFA system to receive FDA approval.

PulseSelect™ Pulsed Field Ablation System

# Medtronic VS Boston Scientific

Medtronic's approval announcement even preceded the FDA's official database; it seems they were really in a hurry. Medtronic's biggest competitor in the PFA field isBoston Scientific, the FARAPULSE Pulsed Field Ablation System under the company isThe First PFA System to Receive CE Certification(January 2021), while Medtronic's PulseSelect pulsed field ablation system received CE certification only in November this year.

FARAPULSE™ Pulsed Field Ablation System

But this time, in this FDA approval battle, Medtronic won.The system will begin commercialization in early 2024.Rebecca Seidel, Senior Vice President of Medtronic's Cardiovascular Portfolio and President of the Cardiac Ablation Solutions business, said: "We have both the PulseSelect Pulsed Field Ablation System and obtained CE certification.Affera™ Mapping and Ablation System(Review:Approved CE! Medtronic Mapping and Ablation System）, and powerfulCryogenic Ablation Platform", providing a variety of solutions for clinicians and their patients."

Affera™ Mapping and Ablation System

Medtronic's PulseSelect Pulsed Field Ablation System received approval in 2018.FDA's "Breakthrough Medical Device" Designation, obtained in January 2020FDA's Investigational Device Exemption (IDE) for clinical trials, currently isThe First Completed IDE Study on PFAThe FDA's rapid approval is also due to the system's excellent clinical trial results.

In March this year, Medtronic reported the IDE experimental results of this system at the American College of Cardiology's Annual Scientific Session and World Congress of Cardiology, announcing that the system exceeded safety performance goals in clinical trials, with recorded...The incidence of adverse events is0.7%, this is one of the systems with the lowest adverse event rates in FDA IDE trials/multicenter PFA studies for atrial fibrillation ablation.

In addition,Clinical Success Rate(No recurrence of any symptomatic atrial arrhythmia) was achieved in each patient group.80%(80% in the paroxysmal group and 81% in the persistent group). Within 12 months, the atrial arrhythmia-free survival rate in the paroxysmal group was70%, The recurrence-free rate of the persistent group was62%。

Boston Scientific's FARAPULSE Pulsed Field Ablation System received approval in 2019.FDA's "Breakthrough Medical Device" Designation. Began in 2021IDE Clinical Trial ADVENT, the experiment was completed in 2022. The 12-month study results were announced this August. The company previously estimatedThe FARAPULSE Pulsed Field Ablation System will receive FDA approval in 2024.How Boston Scientific will counterattack remains to be seen.

However, some analysts have stated that compared to the studies evaluating Boston Scientific's Farapulse and Biosense Webster's VariPulse systems (from Johnson & Johnson),Medtronic's study has stricter atrial fibrillation monitoring and endpoints.。

# About PulseSelect™ Pulsed Field Ablation System

PulseSelect™ Pulsed Field Ablation SystemPrioritize the ablation of pulmonary veins., because it relies on pulsed electric fields rather than thermal effects, which avoids damaging the tissue surrounding the ablation site. The system's ablation catheter uses proprietaryBiphasic WaveformAndUnique Inner Conductor Design. The catheter head has multiple electrodes and can be transformed by stretching and contracting."Disc-shaped"(Diameter 25 mm), designed for operational convenienceTilt forward 20°Medtronic stated that, according to clinical trial data, the ablation catheter can deliver pulsed energy.Isolate all pulmonary veins in about 30 seconds.。

This pulsed electric field ablation system consists of a steerableMulti-electrode circular ablation catheter, custom FPA generator, electrocardiogram, bedside control,FlexCath Contour™ Bidirectional Sheath with a Diameter of 10Fr(Not yet received any official approval)Composed of five parts.

The system has the following characteristics:

Plug and Play:PulseSelect™ is a plug-and-play system that can be used with any mapping system and even directly with X-ray fluoroscopy.

Built-in Safety Features:Equipped with phrenic nerve test pulses, the voltage of these test pulses is very low. Before starting the formal ablation, this test voltage can be used to evaluate whether the ablation catheter is close to the phrenic nerve.

Nine electrodes with fixed spacing:Since the nine electrodes at the catheter head form a disk shape with fixed spacing between each other, the generated electric field is consistent, facilitating continuous ablation. Additionally, these nine electrodes can also be used for pacing and sensing.

Small catheter diameter:The ablation catheter has a small diameter of only 9Fr (housed within a 10Fr outer sheath), allowing the catheter to easily navigate various anatomical structures.

FlexCath Contour™ Steerable Sheath - 10 Fr

The demonstration video of the system is as follows:

# Medtronic's PFA Journey

Since 2006, Medtronic has been conducting large-scale preclinical and clinical trials to study the safety and efficacy of applying "Irreversible Electroporation (IRE)" technology to cardiac ablation.

2006

Initiate preclinical experiments to evaluate the feasibility and effectiveness of using electromagnetic pulses in epicardial ablation procedures.

22008

First application for a patent in the field of cardiac ablation using electroporation technology.

2009

Initiate preclinical experiments to gain a more detailed understanding and optimize the IRE technology for cardiac tissue ablation.

2014

Continue with preclinical experiments, focusing on the effects of IRE technology for endocardial radiofrequency ablation.

2015

Established a long-term cooperative relationship with Professor Damijan Miklavčič (a world-leading expert in IRE technology with over 25 years of experience).

2018

Coined the term "pulsed field ablation (PFA)"Used to refer to the IRE technology for cardiac ablation.

2019

The first procedure of the "PULSED AF" atrial fibrillation pilot trial was performed by Bradley Wilsmore in December.

2020

Principal investigator of the study, Dr. Atul Verma, presented the acute results of the "PULSED AF" atrial fibrillation pilot trial at HRS (Heart Rhythm Society).

2021

"PULSED AF" Key Trial Completed Enrollment in November.

2022

Acquisition of Affera™ Mapping and Ablation System

2023

"Key 12-month results of the 'PULSED AF' atrial fibrillation trial were published by principal investigator Dr. Atul Verma."CirculationIn the magazine.

# About Medtronic

Medtronic is a global leading medical technology company, established in 1949, with its headquarters in Minneapolis, Minnesota, USA. The company mainly focuses on providing lifelong treatment, diagnosis, and monitoring solutions for patients with chronic conditions such as cardiovascular diseases, neurological disorders, diabetes, and spinal conditions.

On August 22, 2023, Medtronic announced its first-quarter financial report for the fiscal year 2024 (FY24) ended July 28, 2023. The financial report showed that MedtronicGlobal revenue in the first quarter of fiscal year 2024 was $7.7 billion (approximately 56.19 billion RMB), a year-on-year increase of 4.5%., GAAP net income in the first quarter was $791 million (approximately RMB 5.76 billion), a year-over-year decrease of 15%. Non-GAAP net income was $1.596 billion (approximately RMB 11.63 billion), a year-over-year increase of 6%. The cardiovascular portfolio, neuroscience portfolio, medical surgical portfolio, and diabetes division allAchieved strong positive growth。

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