Source: Heart Future; Editor: Sophia
Reprint Requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.Recently,Medtronic(New York Stock Exchange: MDT)Announced itsPulseSelect Pulsed Field Ablation (PFA) SystemObtained Regulatory Approval in Japan。Japan's Ministry of Health, Labour and Welfare approved following the pivotal PULSED AF trial, a global multicenter IDE study in which research centers in Japan also participated.The product wasApproved by the U.S. FDA in December 2023For treatmentParoxysmal and Persistent Atrial Fibrillation, becomingThe First FDA-Approved PFA System。
According to Medtronic, more than 250 doctors worldwide have used PulseSelect.Successfully treated more than 3,000 patients, used together with the company's bidirectional 10F FlexCath Contour sheath.
# PulseSelect Pulsed Field Ablation SystemPulseSelect Pulsed Electric Field Ablation SystemBy steerableMulti-electrode circular ablation catheter, Custom FPA Generator, ECG, Bedside Controls,FlexCath Contour Bidirectional Sheath with a Diameter of 10Frand so on.
- Prioritize the ablation of pulmonary veins., relying on pulsed electric fields rather than thermal effects,Avoid damaging the tissue surrounding the ablation site。
- Ablation catheter adoptsProprietary biphasic waveformAndUnique Inner Wire DesignThe catheter head has multiple electrodes, which can be transformed into a "disc shape" (25 mm in diameter) through expansion and contraction for ease of operation.Tilt forward 20°。
Plug and Play:Can be used with any mapping system and can be directly paired with X-ray fluoroscopy imaging.Built-in Safety Features:Equipped withPhrenic Nerve Test Pulse, the phrenic nerve test pulse voltage is very low, and this test voltage can be used before the formal ablation begins.Evaluate whether the ablation catheter is close to the phrenic nerve。Nine electrodes with fixed spacing:Since the nine electrodes at the catheter head are fixed in a disk shape with fixed spacing between each other, the resultingUniform electric field，Convenient for continuous ablation.
In addition, 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.
# Software Upgrade
Medtronic also stated that PulseSelect has newSoftware Upgrade, includingAutomatic Drug Administration Mode,Further simplify the workflow, providing doctors with more options to control PFA during surgery.Medtronic has completed the upgrade of existing systems in Europe and Canada, the system upgrade in the United States has been initiated, and it will be rolled out to more countries, including Japan, after approval is obtained.
# Real-World Data
At the 2023 American ACC Annual Meeting, the PulseSelect system announced the data from its PULSED AF Pivotal clinical study.All exceeded the expected safety performance goals.。
Data shows that the application of PulseSelect for atrial fibrillation ablation,Incidence of adverse events only 0.7%，Is currently submitted to the FDA's PFA clinical trial and other PFA clinical studiesThe Lowest。
Within 12 months, paroxysmal group atrial arrhythmiaThe non-recurrence rate is70%, Persistent GroupThe Non-Recurrence Rate is62%。In addition,Clinical Success RateAt least 80% was achieved in each patient group.(80% in the paroxysmal group and 81% in the persistent group).
Pulsed AF Study Results ShowSafety and Effectiveness of the PulseSelect System。
In addition, the PulseSelect system exceeded the efficacy threshold at 12 months in both groups.The total efficacy demonstrated in patients with paroxysmal atrial fibrillation was 66%.，55% in patients with persistent atrial fibrillation。President of Medtronic's Cardiac Ablation Solutions BusinessRebecca SeidelSaid in a press release:"We have seen tremendous enthusiasm and adoption for PulseSelect across markets in the United States, Europe, and Canada.Many users of PulseSelect have unanimously praised its safety, ease of operation, and flexibility."Now, the expansion of PulseSelect into the Japanese market is good news for both doctors and the patients they serve, who deserve the most advanced, safe, and efficient treatment for atrial fibrillation."# The Battle of the PFA Giants
Pulsed Field Ablation (PFA) is also known as irreversible electroporation., which refers to the application of high-voltage electrical pulses to the phospholipid bilayer of the cell membrane in a short period of time, leading to the formation of transmembrane potential and generating unstable electric potential,Causing irreversible permeability damage to the cell membrane, generating nanoscale pores, which in turn causes changes in cell membrane permeability and disrupts the homeostasis of the intracellular environment,Ultimately leading to apoptosis, achieving the purpose of non-thermal ablation.。
According to FMI data, from 2021 to 2022, the global pulsed field ablation market experienced a compound annual growth rate of 48.6%.By 2023, the market size will reach$1.3 million。From 2023 to 2033,Global Pulsed Field Ablation Industry Expected to Grow at a CAGR of 24.2%。
Precisely because of the high growth potential of pulsed field ablation, it is also considered to be the next generation of disruptive ablation technology.Medtronic, Johnson & Johnson, Boston ScientificMultinational medical device companies have all started to lay out related product pipelines.December 2023,MedtronicPulseSelect Pulsed Field Ablation System Receives FDA ApprovalBecoming the First to Receive FDA Approval for Pulsed Field Ablation Technology. Previously in November, PulseSelect PFAObtaining the CE Mark。In the same month, PFA made in China also achieved a breakthrough,Jinjiang Electronics"Single-Use Cardiac Pulsed Field Ablation Catheter PulsedFA" and "Cardiac Pulsed Field Ablation System LEAD PFA" innovative products have officially received NMPA approval.The First Approved Cardiac PFA Product in China。Subsequently,Boston ScientificPulse Electric Field Ablation DeviceFarapulse Receives FDA Approval in January 2024; At the beginning of 2021, the Farapulse PFA SystemReceived CE Approval for Market Launch。Johnson & JohnsonThe pulsed electric field ablation device Varipulse in January 2024Approved for marketing by Japan's Ministry of Health, Labour and Welfare (MHLW), applicable for the treatment of symptomatic drug-refractory recurrent paroxysmal atrial fibrillation. This is the first PFA product approved in Japan.The company plans to submit an FDA application in 2024.。▲Reference Medtrend Medical TrendsIt is worth mentioning that,PFA products from Medtronic, Johnson & Johnson, and Boston Scientific have all entered the NMPA Innovative Medical Device Special Review Process.。Nearly 50 enterprises in China are currently developing PFA cardiac ablation systems.Denovo EP and Beixing Medical's PFA products have also entered the NMPA special review process. HT Medical, XuanYu Medical, Aikangmai Medical, Maiwei Medical, XinLvTong, ZhouLing Medical, YuanShan Medical, and HeartNavigator Medical, among other companies, have also successively laid out plans for PFA.However, for a blue ocean track that is starting commercial landing, with the approval of PFA products from many manufacturers at home and abroad,How to break through in the shift from a blue ocean to a red ocean is a question worth careful consideration for all players.。Medtronic (Medtronic, NYSE: MDT) was founded in 1949, with its headquarters in Minneapolis, Minnesota, USA. It is a global leading medical technology company with over 95,000 employees.
Medtronic's innovative solutions have expanded to more than 70 key disease areas, committed to providing lifelong treatment options for patients with chronic conditions. Every second, two patients worldwide benefit from Medtronic's medical technologies or therapies.Medtronic's main businesses includeCardiovascular, Medical Surgery, Neuroscience, and DiabetesFour business blocks, includingThe highest proportion is cardiovascular.。What Does Medtronic Sell? A Comprehensive Overview of the Cardiovascular Product Line
Taking the 2023 financial report as an example, the company's total revenue was $31.227 billion, ranking first in revenue among global medical device companies. Revenue from the cardiovascular business was $11.573 billion, accounting for 37.06%, includingCardiac Rhythm and Heart Failure (CRHF), Structural Heart and Aorta (SHA), and Coronary and Peripheral Vascular (CPV)Three departments.
▲2023 Annual Report (Source: Company Official Website)
