NeuWave wins FDA nod for Ablation Confirmation software

NeuWave Medical said today it won FDA premarket approval for its Ablation Confirmation software, which will be integrated into its Intelligent Ablation system.

The new system uses computed tomography which allows physicians to visualize and confirm ablation targets and lesions using images from CT scanners, according to the company.

The computer-contolled ablation system also has greater access to data gained during the process and is able to use it to streamline the procedure, CEO Dan Sullivan told MassDevice.com in an interview.

“Because we have computer control, 1 of the things we have access to is data. So, we record the ablation, how long it lasts, what power they used and what type of lesion and tissue it was in. One of the challenges with ablation is how to confirm that the probe or the needle is actually in the lesion, and how to confirm whether you have the ablation zone covering the lesion completely,” Sullivan said.

During standard ablations, operating physicians are required to take multiple scans during the process to make sure the ablation zone has completely covered the lesion and may require extra scans to position the needle for ablation, Sullivan said. With NeuWave’s new computer controlled model, the software automatically perform parts of this task and can feed a compiled image from a CT scanner to any connected computer he said.

“With ablation confirmation, we’ll tie our system right into the hospitals CT scanner. We have software in it that will overlay those images. So, when they put the probe into the lesion, they’ll be able to spin that around right in the procedure room on a screen on our system in 3 dimensions and look at it from all angles to confirm the needle is in the lesion prior to ablation,” Sullivan said.

Sullivan said that the system would allow the operators to quickly share the images and collaborate on procedures with other faculty and advisors, as well as adding the images during and after the procedure to the patients file automatically.

NeuWave is also developing a flexible catheter for use with the system, aiming for transbronchial applications, with 1.8 million malignant lung lesions diagnosed each year.

“There’s a significant need for tools to do soft-tissue ablation in the lungs,” Sullivan said.

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