Surgical Tool FDA Cleared

 

CertuSurgGT Receives FDA Clearance

CertuSurg GT

NeuWave Medical® has received 510K marketing clearance from the United States Food and Drug Administration (FDA) for the CertuSurgGT Surgical Tool. The device is designed to produce focal, rapid coagulation of soft tissue in open surgical applications, including planar coagulation performed prior to tissue resection. The CertuSurgGT boasts an ergonomic design to offer the surgeon control. It is a convenient to use hand-held surgical tool with a 6cm, 17 gauge cannula that offers a generous cable length of more than 9 feet. The handle of the device contains a finger-activated power delivery mechanism that can conveniently control power delivery without requiring the user to also interact with the Certus® 140 ablation system's touch screen interface.

Optimized Energy Transfer for Different Tissue Types.

The CertuSurgGTsurgical tool is one of a variety of sterile, single-patient use energy delivery accessories (ablation probes and surgical tools) available for use with the Certus 140 Microwave Ablation System from NeuWave Medical. Each energy delivery accessory contains temperature measurement sensors that help monitor performance during a procedure and ensure patient and operator safety.  Additionally, the various percutaneous ablation probes offered for use with the Certus 140 system have been designed to optimize the energy transfer efficiency from the probe into different types of tissue based on known electrical properties of each tissue.

Pairs With the Premier Soft Tissue Ablation System.

The Certus 140 is engineered to be the premier soft tissue ablation system available worldwide, maximizing power delivery to create large, predictable ablation zones when needed, while also offering PrecisionTM probe technology for creating smaller, tip-weighted ablations to address small lesions even in challenging locations.  A revolutionary CO2-based cooling system enables Tissue-LocTM technology to secure probes to tissue upon placement, and allows Certus 140 probes to be the least invasive, smallest diameter (17-gauge) microwave ablation probes available.

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