Varipulse (pulse ablation system)

History

2025: Suspension of the process of bringing to market due to emerging cases of strokes

On January 8, 2025, Johnson & Johnson announced the suspension of the process of bringing Varipulse cardiac devices to the market. It turned out that this medical device can provoke strokes.

Varipulse is a pulse ablation system that is designed to treat some heart rhythm disorders. When Varipulse is applied, accurate catheter imaging in the patient's anatomy is claimed to allow the physician to perform ablations strictly at specific locations to isolate pulmonary veins. The platform uses a patented pulse sequence, which, according to the developers, provides selective properties and allows you to preserve the architecture of fabrics. The whole procedure lasts about 30 minutes.

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Фото: Johnson & Johnson

The integrated Varipulse platform is designed to carry out high-precision ablation, which potentially maximizes safety and efficiency, the manufacturer's website says.

It is reported that as of the beginning of January 2025, four cases of stroke were recorded after the use of the Varipulse pulse ablation system. In particular, the database of reports on medical devices submitted by manufacturers to the US Food and Drug Administration (FDA) contains information that a patient enrolled in the Varipulse study had a stroke shortly after treatment. Similar complications have been recorded in at least two more patients in Europe. In this regard, Johnson & Johnson initiated a special audit.

We are working diligently to complete the investigation in accordance with our procedures. Patient health and safety are our top priorities, the company said in an official statement.[1]

Notes