Endoscopic cryo-ablation company CSA Medical said today it won expanded FDA 510(k) clearance for its TruFreeze spray cryotherapy system, now cleared for use on patients with Barrett’s esophagus with low grade dysplasia.
With the clearance, the device is now approved for both low and high grade dysplasia as well as malignancies, the Boston-based company said.
“Over the past few years, studies have underscored the potential risk for Barrett’s esophagus with low grade dysplasia to progress to esophageal adenocarcinoma. Intervening at this level of dysplasia has become common practice and is recognized in our society guidelines. My colleagues and I have used liquid nitrogen spray cryotherapy for over a decade to treat Barrett’s esophagus with high levels of efficacy and patient tolerability. With approval of this expanded label, the FDA has recognized spray cryotherapy’s ability to positively impact the lives of our Barrett’s patients,” Dr. Michael Smith of New York’s Mount Sinai hospitals said in a press release.
The TruFreeze system is designed as a cryosurgical tool designed for use in dermatology, gynecology, general surgery and to ablate benign and malignant lesions.
The company touts the TruFreeze device as the only ablation technology designed to ablate Barrett’s Esophagus with a high grade dysplasia or cancers as such as in the esophagus with a non-contact liquid nitrogen spray cryotherapy system.
“We are pleased to have obtained FDA clearance to expand our indications for use to include Barrett’s Esophagus with low grade dysplasia as an example of benign disease ablation as well as our present indication for Barrett’s Esophagus with high grade dysplasia and malignant disease ablation. The data set that formed the basis of this claim came from our prospective post market registry that delineated ablation using truFreeze spray cryotherapy as specified in our instructions for use. Achieving a CE-D rate of 95.5% in this patient cohort is in keeping with numerous previously published truFreeze reports,” CSA Medical prez & CEO Dr. Ellen Sheets said in a prepared statement.
In July, CSA Medical said it won FDA 510(k) clearance for a 3rd spray kit, the rapid AV spray kit, for its TruFreeze system.