CSA Medical, Inc. has expanded its truFreeze label with the addition of Barrett’s Esophagus (BE) with low-grade dysplasia.
CSA Medical develops and manufactures a proprietary interventional spray cryotherapy technology platform utilising 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.
The expansion of the truFreeze label comes after the submission of clinical data supporting the use of truFreeze Spray Cryotherapy in patients with BE and low-grade dysplasia. The Food and Drug Administration (FDA) has now recognised the safety and effectiveness of the trueFreeze system.
Michael S. Smith, Managing Director, Master of Business Administration, incoming Chief of Gastroenterology; Hepatology at Mount Sinai West and Mount Sinai St. Luke’s Hospitals; Associate Professor of Medicine at the Icahn School of Medicine at Mount Sinai in New York, said, “My colleagues and I have used liquid nitrogen spray cryotherapy for over a decade to treat BE with high levels of efficacy and patient tolerability. With approval of this expanded label, the FDA has recogniSed spray cryotherapy’s ability to positively impact the lives of our Barrett’s patients.”