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Surgical sealant for GI procedures receives CE marking
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The European Commission has given a CE mark to Seal-G, a surgical sealant designed to reduce leaks after gastrointestinal procedures, according to a press release issued by Sealantis, the manufacturer.
Seal-G will now be available in Europe in addition to several other countries, although it has not received approval by the FDA nor is it available in the U.S., according to the press release.
“The Seal-G CE marking approval represents a key milestone on our journey to commercialize the Sealantis platform technology,” Avi Kerbs, chairman of Sealantis and CEO of the Teuza fund, said in the press release. “We look forward to making Seal-G available to patients and surgeons in Europe, China and globally.”
Seal-G is designed to stop anastomotic leaks, a serious complication that effects as many as 15% of patients who undergo gastrointestinal surgery, by reinforcing the suture or staple line during the post-surgery period. One-third of all post-surgical mortality after colorectal surgery is caused by leaks, according to the press release.
“The CE marking approval for Seal-G is a major achievement for our team,” Tomer Fuchs, CEO of Sealantis said. “This approval clearly indicates that Seal-G and our supporting quality system met the essential requirements for product safety, performance and usability, in compliance with growing rigorous requirements set by the EU regulations.” – by Alex Young
Disclosures: Kerbs and Fuchs are employed by Sealantis.