Four neurovascular events reported; FDA review underway.
Johnson & Johnson (J&J) announced it is coordinating with the U.S. Food and Drug Administration (FDA) following a pause in U.S. cases involving its Varipulse pulsed field ablation (PFA) device. The halt, initiated in early January 2025, stems from reports of four neurovascular events, raising safety concerns.
Key Updates from J&J’s Earnings Call
- Safety Prioritised: Tim Schmid, J&J’s worldwide chairman of medtech, emphasized patient safety as the company works to identify the cause of the reported events.
- Impact Limited to U.S.: The pause affects only U.S. procedures; international Varipulse cases continue uninterrupted.
- Ongoing Investigation: J&J is actively engaging with the FDA to resolve the issue but did not provide a timeline for resuming U.S. operations.
Market Impact and Challenges
J&J’s pause in U.S. Varipulse procedures has significant implications in the competitive PFA space, a growing field for treating atrial fibrillation. Competitors Boston Scientific and Medtronic already offer PFA systems in the U.S., placing J&J further behind in this race.
Cardiovascular Portfolio Performance
Despite the setback, J&J’s cardiovascular business delivered strong results in 2024, achieving $7.71 billion in revenue, a 21.4% year-over-year increase. Highlights include:
- Abiomed: Contributed $1.5 billion in sales, representing 14.5% growth.
- Shockwave Medical: Generated $564 million in revenue, benefitting from J&J’s $13.1 billion acquisition in 2024.
Schmid expressed optimism about the cardiovascular segment, emphasizing J&J’s first-mover advantage in emerging markets like intravascular lithotripsy, secured through Shockwave’s cutting-edge technology.
Follow MEDWIRE.AI for the latest on regulatory updates and innovations shaping the medtech industry.
