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CSA Medical receives FDA 510(k) clearance for liquid nitrogen cryotherapy spray system
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CSA Medical announced it has received FDA (510K) clearance for the expansion of its truFreeze catheter liquid nitrogen spray cryotherapy system to include a third spray kit, which will be referred to as the Rapid AV Spray Kit.
The Rapid AV catheter’s properties shortens the time to liquid nitrogen spray by 50%, decreasing overall treatment time, according to a news release. The truFreeze system is indicated as a cryosurgical tool in dermatology, gynecology and general surgery, and to ablate Barrett’s Esophagus with high grade dysplasia and malignant lesions.
CSA announced that truFreeze is the only ablation technology for Barrett’s Esophagus with high-grade dysplasia, or cancers such as in the esophagus by using a noncontact liquid nitrogen spray technology 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 shorter procedural time,” Ellen Sheets, MD, CEO and president of CSAMedical, stated in the release.
The truFreeze process involves cells being selectively destroyed while the underlying collagen tissue structure is preserved providing a scaffold for healthy tissue regrowth, according to CSA Medical’s website.
Reference: www.csamedical.com