Varipulse

Maybe I get the gist of this but is it a significant step forward in ablation technology and effectiveness.

[www.jnj.com]

There are two competing companies that the FDA has approved for pulsed field ablation in the US—this product and Farapulse by Boston Scientific. They both use the same basic technology but proprietary waveforms, energy, and catheter design differentiate them. Since both products are fairly new in the USA there will be competition to become the most prominent product. Since both offer Pulsed Field Ablation which is a safety improvement over previous technology it remains to be seen which product wins the market share. Expect to see more press releases and “news” as various institutions adapt a particular device as both companies are active on the Public Relations side. This is how technology and care move forward however—companies invest in research and development and then when they develop new technology that is effective and approved they market it aggressively to recoup investment and turn a profit. Pulsed field is a real improvement I think and I hope to be getting my Pulsed Field ablation soon.

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cjkdm
This is how technology and care move forward however—companies invest in research and development and then when they develop new technology that is effective and approved they market it aggressively to recoup investment and turn a profit.

It's also, quite often, the first time we really hear about the (industry-known but not generally well publicized to the consumer) downsides of the former/other/competition's device or technology as the company touting The Latest And Greatest seeks to explain why their gizmo is significantly better ;-)

This is a win-win for the patient. We should expect, and support, competition as it tends to keep prices low and advancements coming in order for the purveyors to stay competitive in an advancing and burgeoning market (the latter because all the literature guesstimates I have seen suggest that there will be close to 25M AF patients in N. America by 2030).

Varipulse just paused their U. S. rollout due to concerns about stroke.
[www.reuters.com]

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Nancy9
Varipulse just paused their U. S. rollout due to concerns about stroke.
[www.reuters.com]

I was feeling kinda encouraged until…….. but guess that’s what research is all about.

I doubt this will halt them for long. All it will do is give a little boost to the competition, and unless you're a stockholder who cares who wins? We just want the best devices.

I didn’t realize it, but it looks like there are several companies with PFA systems (Farapulse, Varipulse, Pulse Select, etc) in the works.
[www.medicaldesignandoutsourcing.com]

I agree—it’s really encouraging to see all the innovation and it’ll be interesting to see how it all develops.

Do systems like these make it easier for EPs, even less experienced ones, more successful at performing ablations?

I don't think there's data on that yet but I expect it does. One of the things that makes RF ablations difficult is judging how much heat, how much contact force, and for how long when making burns. And to make it even more complicated, all those variables change depending on where you are in the atrium. For example, if you're ablating the posterior wall of the left atrium, you're right up against the esophagus, so you have to be very careful. One of the worst complications possible in an ablation is burning the esophagus. But PFA simplifies all that and makes those injuries unlikely, so an inexperienced EP can focus more on what needs ablating and worry less about doing harm. I think that has to make the procedure easier.

Thanks for the great explanation.