The FDA has granted 510(k) clearance to add Barrett’s esophagus with low-grade dysplasia to the label of CSA Medical’s truFreeze liquid nitrogen cryotherapy spray system, the company announced.
The truFreeze system is safe and effective for ablating low- to high-grade dysplasia in Barrett’s esophagus and malignancies, enabling physicians to treat benign and malignant lesions with the device.
“Over the past few years, studies have underscored the potential risk for Barrett’s esophagus with low grade dysplasia to progress to esophageal adenocarcinoma,” Michael S. Smith, MD, MBA, incoming chief of gastroenterology and hepatology at Mount Sinai West and Mount Sinai St. Luke’s Hospitals, and associate professor of medicine at the Icahn School of Medicine at Mount Sinai in New York, said in a press release. “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.”
The label expansion follows the submission of clinical data from the company’s prospective post market registry, which supports the use of the device for low-grade dysplasia in Barrett’s esophagus, according to Ellen Sheets MD, CEO and President of CSA Medical.
“Achieving a CE-D rate of 95.5% in this patient cohort is in keeping with numerous previously published truFreeze reports,” she said in the press release.
The release noted that this new development will support coverage decisions moving forward.
Disclosures: Sheets is employed by CSA Medical. Healio Gastroenterology was unable to confirm Smith’s relevant financial disclosures at the time of publication.