Johnson & Johnson Halts U.S. Use of Varipulse PFA System Amid Stroke Reports

Jan 09, 2025 13:30 CST Updated 13:30

Johnson & Johnson

Medical Device R&D and Manufacturer

On January 8, according to the latest news from Reuters, Johnson & Johnson Medical Technologies (New York Stock Exchange code: JNJ) announced that starting from January 5,It "temporarily suspended" all U.S. cases using its Varipulse pulsed field ablation (PFA) system.This pulsed field ablation system received FDA approval just two months ago.

"Out of an abundance of caution, Johnson & Johnson Medical Technologies has temporarily paused U.S. external evaluations and all U.S. Varipulse cases while we investigate the root cause of four reported neurovascular events in U.S. external evaluations," the company said in a press release.

"Since the U.S. external assessment utilized a unique platform configuration, it will not impact commercial activities outside the U.S. or the Varipulse case."

The Varipulse platform treats atrial fibrillation (AFib) through a single device that combines PFA with the Carto 3 mapping system. Its variable loop, multi-electrode Varipulse catheter uses laser-cut nitinol tubing for the loop shape and is adjustable between 25mm and 35mm. The platform also includes the TruPulse generator and the Carto 3 3D cardiac mapping system.

Approved Only 2 Months Ago, Sales Suspended

Johnson & Johnson's (J&J) Varipulse received FDA approval in November 2024, joining Medtronic and Boston Scientific as the three major companies with PFA technology approved for treating AFib.

Since the start of external evaluations, the company has reported over 130 Varipulse cases in the United States. These activities were conducted across 14 sites and involved 40 operators. Globally, it has reported more than 3,000 Varipulse commercial cases.

"We are working hard to complete the investigation according to our medical safety procedures and resume external evaluations in the United States. We expect to have more information to communicate in the coming days," the company said.

| Analyst Opinion

Needham analysts Michael Matson, David Saxon, and Joseph Conway reported that an unnamed electrophysiologist confirmed Johnson & Johnson "has suspended sales of its Varipulse PFA system due to reports of the device causing strokes."

He added that,Johnson & Johnson also suspended the international promotion of the device last year, with mixed feedback from doctors.。

They also cited a stroke report from the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. This indicates that a patient experienced a stroke after Varipulse treatment. Analysts stated,At least two patients in Europe have suffered strokes following Varipulse surgery.。

"It is currently unclear how long the sales of Varipulse will be suspended, but even if Johnson & Johnson allows sales to resume, we believe the product may now be considered contaminated, and electrophysiologists may be cautious about using it," the analyst wrote. He also noted that ifBoston Scientific and Medtronic's systems do not have similar issues, and they are expected to benefit from this.

Triangular Standoff: Is Boston Scientific the Biggest Winner?

Medtronic's PulseSelect PFA System became the first to receive FDA approval for treating AFib in 2023. Boston Scientific followed closely, launching the Farapulse System in January. Medtronic expanded its portfolio in October, gaining FDA clearance for its Affera Mapping and Ablation System equipped with the Sphere-9 catheter.

Analysts said they believe Boston Scientific's Farapulse "has been largely validated given the large number of real-world procedures and no signs to date of an elevated stroke rate."

"This news makes usMore Optimistic About Boston Scientific Related Products, because our recent downgrade has mainly focused onThe competitive risks brought by the release of Medtronic and Johnson & Johnson's PFA products.”

Boston Scientific:In January 2024, the Farapulse Pulsed Field Ablation (PFA) System received approval from the U.S. FDA for the treatment of drug-refractory, recurrent, symptomatic, paroxysmal atrial fibrillation by isolating the pulmonary veins; On July 8, 2024, the FARAPULSE™ series of pulsed field ablation products, including the FARAWAVE Single-Use Cardiac Pulsed Field Ablation Catheter and the FARASTAR Cardiac Pulsed Field Ablation System, received approval from China's National Medical Products Administration (NMPA).

Medtronic:In November 2023, the PulseSelect pulsed field ablation system received CE approval; in December 2023, it received U.S. FDA approval for the treatment of paroxysmal and persistent atrial fibrillation; in May 2024, it received regulatory approval in Japan; in September 2024, its PulseSelect system received NMPA approval in China.

Johnson & Johnson:In February 2024, the Varipulse pulsed electric field ablation system received CE approval, and in November 2024, the Varipulse pulsed electric field ablation system received FDA approval.

Johnson & Johnson further explained,Commercial activities and cases outside the United States will not be affected by the suspension.。

Boston Scientific said last month that it expects PFA to account for 40% to 60% of atrial fibrillation ablation procedures worldwide by around 2026.

Notably, in its latest quarterly earnings report, Johnson & Johnson projected that the integration of its industry-leading sales network mapping system would help garner support for Varipulse in the U.S. market. The company stated that Varipulse is the only U.S. PFA system fully integrated with the Carto 3 mapping system.

Johnson & Johnson Medical Technology Chairman Tim Schmidt told analysts on the earnings call in October 2024,The company's $5 billion electrophysiology business grew 11% year-over-year in the last quarter, with its mapping system being utilized in over 50% of competitive cases.。

Atrial fibrillation is one of the most common types of arrhythmia, affecting the health of tens of millions of people worldwide, includingMore than 11 million people in Europe, at least 8 million in the United States, and approximately 1.3 million in JapanIt is estimated that about one-quarter of people over the age of 40 face the risk of developing this disease. Such a large patient population provides a broad potential market for pulsed field ablation products.

According to Frost & Sullivan analysis, the size of China's PFA market is expected to reach 1.3 billion RMB by 2025 and will grow at an astonishing rate to reach 16.3 billion RMB by 2032, with a compound annual growth rate (CAGR) as high as 43.73% during this period.

In the current tripartite situation of the PFA U.S. market, Johnson & Johnson has suspended sales in the U.S. How will the future landscape unfold? What is your take?

▲ Source of the article:Medical Device Innovation Network

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