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CSA Medical gets FDA clearance for truFreeze system

Published 18 July 2017

CSA Medical has announced an advancement of its catheter technology with the expansion of its truFreeze catheter offerings to include a third Spray Kit for the truFreeze System, referred to as the Rapid AV Spray Kit.

 The Rapid AV catheter has a material property change such that it provides the ability to shorten the time to liquid nitrogen spray by 50%.  The shortened time to liquid nitrogen spray decreases treatment time overall as well.

The truFreeze System is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign (e.g. Barrett's Esophagus with high grade dysplasia) and malignant lesions.

truFreeze is the only ablation technology that ablates Barrett's Esophagus with high grade dysplasia, or cancers such as in the esophagus, utilizing a non-contact liquid nitrogen spray cryotherapy system.  The truFreeze system makes it possible to deliver liquid nitrogen inside the body in a way that is far colder than is needed to effectively destroy these tissue types by a factor of >2.

"We are pleased to have obtained FDA clearance to expand our product offerings for our truFreeze System.  With the addition of the Rapid AV Spray Kit, it is anticipated that physicians will be able to substantially reduce treatment times such that patients have a shorter procedural time," says Ellen Sheets MD, CEO and President of CSA Medical. 

This product expansion reiterates truFreeze as a treatment option for Barrett's Esophagus, and malignant lesions and supports coverage decisions for truFreeze patient treatments.

CSA Medical, Inc. develops and manufactures a proprietary interventional spray cryotherapy technology platform utilizing unique properties of liquid nitrogen spray delivered by a software driven device with specialty catheters that enable delivery of spray cryogen inside the body to flash freeze and destroy unwanted tissue allowing for a rejuvenative pattern of healing.

CSA manufactures and distributes this technology in the USA as the truFreeze® system which is currently used to ablate benign (e.g. Barrett's Esophagus with high grade dysplasia) and malignant lesions.



Source: Company Press Release