Johnson & Johnson Secures CE Mark for Varipulse PFA System, Completing the Triad with Boston Scientific and Medtronic

Mar 01, 2024 17:35 CST Updated 17:35

Johnson & Johnson

Healthcare Product Manufacturers, Health Service Providers

Johnson & Johnson said on Thursday that its Varipulse Pulse Field Ablation (PFA) device hasObtained European CE Mark, This device is used to treat atrial fibrillation (AFib), a common form of irregular heartbeat that increases the risk of stroke.

This approval enables Johnson & Johnson to engage in a battle for market share with Medtronic and Boston Scientific.Vying for a promising new technology to treat arrhythmia (asynchronous upper and lower ventricular beats). The Varipulse device has also recentlyHas been approved in Japan.

Johnson & Johnson stated that the safety and efficacy of its platform areIn the Inspire clinical trialThe study included 186 patients from Canada and Europe.

The Three Giants Rush into a New Track

PFA uses electrical pulses to ablate cardiac tissue responsible for rhythm disturbances, and has attracted significant interest from physicians due to its potential to avoid complications associated with traditional thermal ablation.

Catheter-based treatments can selectively ablate tissue to reduce the risk of damage to surrounding structures such as the esophagus and pulmonary veins.

According to Medtronic and Boston Scientific, the PFA system has been used in Europe and received positive feedback. Medtronic and Boston Scientific have also recentlyReceived approval from the U.S. Food and Drug Administration (FDA), can launch its PFA device in the United States.

Source of the image: MedTrend

Approval Timeline:

CE：

In January 2021, Boston Scientific's FARAPULSE Pulsed Field Ablation System became the first PFA system to receive CE certification.
In November 2023, Medtronic's PulseSelect Pulse Field Ablation System received the second CE certification as a PFA system;
On February 29, 2024, Johnson & Johnson's Varipulse pulsed electric field ablation system received its third CE certification.

FDA：

In December 2023, Medtronic's PulseSelect received the FDA's first approval for PFA treatment of paroxysmal and persistent atrial fibrillation.
On January 31, 2024, Boston Scientific Corporation announced that it has received FDA approval for the FARAPULSE™ Pulsed Field Ablation (PFA) System;
Johnson & Johnson is expected to receive FDA approval in 2024.

Johnson & Johnson Once Obtained Japanese Certification

Johnson & Johnson's pulsed field ablation device VARIPULSE received approval in Japan in January 2024.

Johnson & Johnson announced the one-year follow-up data of the Inspire trial at the AF Symposium in Boston this month.The data show that 80% of patients treated with optimal PFA achieved freedom from recurrence and had no major adverse events.

The primary efficacy endpoint of the study was acute pulmonary vein isolation and freedom from atrial arrhythmia recurrence at 12 months, which was 75.6%.

"Most importantly, the data recently released on the Varipulse system platform demonstrates the safety of using pulsed field ablation to treat patients with AF," said Tom De Potter, deputy director of the Cardiovascular Center at OLV Hospital in Aalst, Belgium, in a statement by Johnson & Johnson.

Johnson & Johnson stated,PlanThis year, the Varipulse catheter will be submitted to the FDA for review.

Pulse Ablation, Global Landscape

In the international market, apart from Medtronic, Boston Scientific, and Johnson & Johnson, there are two other strong performers in the PFA field.

One isGalvanize Therapeutics, the company's CENTAURI PEF is the second PFA technology to receive CE certification. However, it only includes the main unit, without catheters or mapping systems, making it unable to compete in the market with giants like Medtronic, Boston Scientific, and Johnson & Johnson. In January 2024, the veteran electrophysiology company CardioFocus announced the acquisition of Galvanize Therapeutics' electrophysiology technology division. The most important assets in this acquisition include the PFA product CENTAURI PEF and the QuickShot ablation catheter (under development). CardioFocus did not previously have PFA technology.

The second isAbbottAbbott occupies the second position in the global electrophysiology market, and its products and movements cannot be ignored. However, currently, Abbott seems to be lagging behind considerably in the PFA field, with its PFA product just entering Phase I clinical trials. It may potentially leapfrog competitors through acquisitions.

In the Chinese market, the strong potential of the domestic market has triggered a surge of competitors in the pulsed electric field ablation market both domestically and internationally.Jinjiang Electronics, founded in 2002, took the lead and launched the first domestically produced PFA cardiac electrophysiology product in China.Including the LEAD-PFA Cardiac Pulse Field Ablation System and the Pulsed FA Single-Use Cardiac Pulse Field Ablation Catheter, characterized by magnetic navigation and integrating 3D modeling, mapping, and ablation.The launch time is almost simultaneous with the FDA approval of Medtronic's PFA product.

The PFA products of Medtronic, Johnson & Johnson, and Boston Scientific have all entered the NMPA Innovative Medical Device Special Review Process.Currently competing for the "first Chinese spot" in the PFA products of foreign-funded enterprises.At least 50 companies in China are currently developing PFA cardiac ablation systems. PFA products from local medical device companies like DiNova (formerly Nuomao Medical) and Beixing Medical have entered the NMPA special review process. Other companies such as HT Medical, XuanYu Medical, Aikangmai Medical, Maiwei Medical, Xin Lü Tong, ZhouLing Medical, YuanShan Medical, and HeartNavigator Medicine have also made strategic moves in this field.

▲ Source of the article:Medical Device Innovation Network, MedTrend

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