Deans' stroke musings: J&J pauses Varipulse pulsed field ablation system's US debut following 4 reports of strokes

Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Wednesday, January 8, 2025

J&J pauses Varipulse pulsed field ablation system's US debut following 4 reports of strokes

FYI. You'll have to ask your competent? doctor if this was because debris from the intervention traveled to the brain.

J&J pauses Varipulse pulsed field ablation system's US debut following 4 reports of strokes

Johnson & Johnson MedTech announced that it has halted U.S. procedures and sales of its recently approved Varipulse pulsed field ablation system following reports of four patient strokes.

“On January 5, out of an abundance of caution, Johnson & Johnson MedTech temporarily paused the U.S. External Evaluation and all U.S. Varipulse cases while we investigate the root cause of four reported neurovascular events in the U.S. External Evaluation,” the company said in its notice.

J&J added that, because the system’s use in the U.S. employed a unique configuration, there is no impact to Varipulse outside of the country.

J&J MedTech secures FDA approval for Varipulse pulsed field ablation system

According to the company, the U.S. external evaluation has included more than 130 procedures among 14 sites and 40 operators as of the top of this year. Varipulse was approved by the FDA last November for treating atrial fibrillation.

The ablation system—which comes integrated with J&J’s Carto 3 heart-mapping catheter—previously received a CE mark approval in Europe in February 2024. The company said Varipulse has been tapped for more than 3,000 commercial cases globally so far.

“We are working diligently to complete the investigation according to our medical safety processes and resume the U.S. External Evaluation,” the company said in its statement. “We expect to have more information to communicate within the coming days.”