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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.
For Further Information
More on the GI endoscopy market in the U.S. can be found in a series of reports published by iData Research entitled the US Market Report Suite for Gastrointestinal Endoscopic Devices 2017 – MedSuite. The suite covers reports on the following markets: GI flexible endoscopy, capsule endoscopy, virtual colonoscopy, endoscopic retrograde cholangiopancreatography (ERCP), stenting and dilation, biopsy, specimen and foreign-body removal, hemostasis, enteral feeding, anti-reflux, and Barret’s Esophagus.
The iData report series on GI endoscopic devices covers the U.S. and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about GI market data or procedure data, register online or email us at [email protected] for a US Market Report Suite for Gastrointestinal Endoscopic Devices 2017 – MedSuite brochure and synopsis.