NeuWave Medical Inc., Receives FDA Clearance for Ablation Confirmation Software
- First and Only, Integrated In-Procedure Confirmation for Ablation of Soft Tissue Lesions -
MADISON, Wis. & MINNEAPOLIS--(BUSINESS WIRE)--
NeuWave Medical® Inc., a privately held medical device company focused on developing disruptive technology for use in the ablation of soft-tissue lesions has received FDA clearance for its new Ablation Confirmation™ (AC) software integrated into the NeuWave Intelligent Ablation System. The totality of the NeuWave System now with AC gives physicians the first, and only, in-procedure confirmation of ablation.
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Ablation Confirmation™ (AC), is a Computed Tomography (CT) image processing software package that assists physicians in identifying ablation targets, assessing proper ablation probe placement and confirming ablation zones post-procedure. AC imports images from CT scanners and facility PACS systems for display and processing during ablation procedures and is accessible to physicians via a dedicated monitor with its own user interface on the NeuWave Intelligent Ablation System. The clearance of AC marks the first and only, integrated in-procedure ablation confirmation software available on an ablation system.
“This is a significant step forward, as today physicians performing an ablation have to view patient CT scans with the naked eye on side by side monitors outside the procedure room. Comparing pre- and post-ablation CT scans is cumbersome and requires the user to ‘imagine’ what the scans would look like if they were overlaid to determine whether or not the lesion has been ablated,” said Dan Sullivan, CEO NeuWave Medical. “Now, with Ablation Confirmation™, only available from NeuWave, there is no need to imagine what the ablation scans look like. The system will overlay pre- and post-ablation scans to show the physician whether or not the ablation is complete, all while never leaving the procedure room. This is game changing for physicians and expected to set a new standard of care for the ablation of soft tissue lesions.”
Clearance of Ablation Confirmation™ marks the completion of NeuWave Medical’s first core percutaneous ablation platform technology and is the only system to offer:
- Computer-controlled synchronous energy delivery for multi-probe ablations
- Versatile percutaneous probe portfolio: for tailored treatments with 1, 2 or 3 probes
- Ablation Confirmation™ for in-procedure review of probe placement and confirmation of the ablation zone
- Big data access for use in case reporting, referral follow up, data publication and to establish potential treatment protocols.
NeuWave Medical is also leveraging its core microwave ablation platform for use with a flexible ablation catheter that is in final stages of development. The initial focus will be on transbronchial, which reflects the approximate 1.8 million new lung lesions diagnosed annually worldwide. Other disease states are expected to follow.
“The vision to integrate Ablation Confirmation™ software into the ablation system goes back to the company’s inception as we set out to create a system that would set a standard of care. The software is just the first step by NeuWave in developing technology that gives users greater confidence to know if they got it all,” said Dr. Fred Lee, Company Co-founder and Professor of Radiology at the University of Wisconsin.
Ablation Confirmation™ offers several new and unique benefits including:
- In-Procedure Confirmation: Ablation Confirmation™ sits resident on the NeuWave Intelligent Ablation System accessing the Hospitals PACS network and the CT scanner in use. AC pulls CT images directly into the software for in-procedure review allowing the physician to review probe placement and ablation confirmation and never break scrub.
- Semi-Automated Lesion Identification: Onscreen system drawing tools that can be used to segment the target lesions, add the desired margin and segment the ablation zone.
- 2D & 3D Visualization: Construction of a two-dimensional and three-dimensional target lesion, probe placement and ablation zone overlay on target.
- Remote Collaboration: Remote viewing and collaboration from an external computer without interruption to workflow in the ablation setting.
- Storage of Images & Procedure Data: The system gives the user the option to create snapshots of the entire work flow for transfer back to PACS to use in case reporting, referral follow up, data publication and to establish potential treatment protocols.
The NeuWave Medical Intelligent Ablation System is currently being used by physicians in more than half of the top cancer institutions in the U.S. to ablate a variety of benign and malignant soft-tissue lesions. NeuWave’s microwave ablation platform works by delivering focused heat to eliminate or “ablate” lesions in the body. One or more antennas, often called “probes,” are placed directly into the lesion and then emit microwave energy from the tip, rapidly oscillating water molecules within the lesion. This oscillation causes friction and enough heat to destroy the lesion. NeuWave Medical’s versatile probe portfolio allows the treating physician to tailor their approach to each patient, maximizing energy delivery and ablating the lesion, while helping to protect non-targeted tissue in the body.
Microwave ablation is most commonly performed as an outpatient procedure done under general anesthesia or moderate/conscious sedation and is covered under a category 1 CPT code. A widely adopted and accepted treatment modality, the National Comprehensive Cancer Network (NCCN) which authors the most practiced guidelines in the world supports the use of percutaneous thermal ablation for lung, kidney and liver lesions. For a copy of the NCCN guidelines please visit, www.nccn.org.
About NeuWave Medical®
NeuWave Medical is a privately held medical device company based in Madison, Wisconsin with a satellite office in Minneapolis, Minnesota. The science and technology behind the NeuWave Intelligent Ablation System is derived from several practicing physicians and PhD’s specializing in ablation from the University of Wisconsin who were looking for a better ablation solution as a way to treat soft-tissue lesions. NeuWave is focused on meaningful clinical innovation and product differentiation to drive better patient outcomes and lower costs. For more information, please visit www.neuwave.com
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