Cryoablation System Effective for Esophageal Disorders

A novel balloon cryosurgical tool treats Barrett's esophagus (BE) and esophageal squamous cell neoplasia (ESCN) effectively and with low patient discomfort.

The Pentax Medical (Tokyo, Japan) C2 CryoBalloon ablation system is a designed to ablate unwanted tissue by application of extreme cold during endoscopy. The system is comprised of a sterile balloon catheter, a controller unit, and a nitrous oxide (NO) cartridge. Treatment sites are selected by adjusting endoscope and controller positions, with the tissue to be ablated then visualized through the inflated balloon. Once in contact with the tissue, the balloon is inflated with NO, rapidly cooling it and ablating unwanted tissue. The NO then exhausts through the controller.

Operation of the system is intuitive, fast (15-30 minutes per procedure), and cost-effective, and also eliminates the need for precise sizing and multiple deployment steps due to the real-time visualization of the esophagus during treatment. The system is compatible with commercially available endoscopes with a minimum working channel inner diameter of 3.7 mm and length of 100 cm. According to clinical studies, 95% of patients treated with the C2 CryoBalloon achieve complete eradication of dysplasia, and 90% have complete eradication of intestinal metaplasia through two years.

“We are committed to advancing the treatment of Barrett's esophagus with a new generation of ablation devices that are easy to use and improve clinical outcomes and patient satisfaction,” said David Woods, global chief marketing officer of Pentax Medical. “C2 CryoBalloon strengthens our therapeutic endoscopy portfolio and is an important technology that enables endoscopists to improve the quality of care they provide to their patients.”

Barrett’s Esophagus develops as a result of chronic injury from gastroesophageal reflux disease (GERD), which causes metaplasia of the normal squamous epithelium lining of the esophagus, replacing them with goblet cells, which are usually found lower in the gastrointestinal tract. The medical significance of BE is its strong association with esophageal adenocarcinoma, a particularly lethal form of cancer.

Cryoballoon technology offers shorter procedure times than point-by-point radiofrequency (RF) ablation, and better treatment outcomes than drug therapy. It has been shown to improve quality of life for patients and significantly reduce paroxysmal (sporadic) AF symptoms, such as palpitations, fatigue, rapid heartbeat, swelling, and syncope.