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Endoscopic suturing device cleared for EU sale
Apollo’s OverStitch endoscopic suturing device has received the CE Mark, allowing them to begin marketing in Europe.
The OverStitch allows physicians to manipulate and suture tissue in the gastrointestinal tract without making incisions through the skin. Apollo are now recruiting for several studies to assess its suitability to be used in a bariatric procedure, suturing the stomach in order to reduce its volume.
Dr Luigi Angrisani, president elect of IFSO, said, "Endoscopic suturing with the OverStitch device provides great potential to transform how we treat the bariatric patient by offering new less invasive endoscopic approaches for both early intervention and the treatment of complications from previous surgical weight loss procedures."
Apollo intend to immediately launch the OverStitch in several European centres.
The device is intended to be mounted on the end of a flexible therapeutic endoscope, and can deliver multiple stitches with a single endoscopic insertion. Apollo currently offer non-absorbable polypropylene sutures, and plan to make absorbably polydioxinone sutures available soon.
"We are pleased to have received the CE Mark for the OverStitch Endoscopic Suturing System and believe the European market provides a great opportunity for Apollo to positively impact the lives of millions of patients, said Dennis McWilliams, president and CEO of Apollo Endosurgery. “Our efforts to improve patient care through less-invasive procedures will continue to highlight endoscopic surgery's prominence in the world of healthcare.”
Apollo say that the device has been successfully used in to repair oesophageal and gastric fistulas, as well as in colon cancer cases. Two studies, sponsored by Apollo Endosurgery and run by the Mayo Clinic and Brigham and Women’s Hospital in the US, are recruiting patients to assess the device’s safety and efficacy in reducing patients’ stomach volume in order to induce weight loss.