Endoscopic device company Apollo Endosurgery, Inc., has announced that its OverStitch™ Endoscopic Suturing System has gained European CE Mark approval.
The company plans to immediately launch the system to select centers in several European countries.
Apollo Endosurgery’s OverStitch platform combines the flexibility of endoscopy with the precision of surgical suturing, allowing physicians to access, manipulate and suture internal tissue without making incisions through the skin.
Apollo claims its platform allows physicians to offer less invasive options for the patient and perform a broad range of endoscopic surgical procedures in the treatment of defects in the digestive tract, gastrointestinal cancer and bariatrics.
The company is working with distributors in several European countries to identify top interventional gastroenterologists and surgeons to participate in the initial phase of the European launch.
“In addition to allowing us to repair defects in the digestive tract that we never could before, this new flexible endoscopic suturing device offers potential advantages over open and laparoscopic surgery including lower risk of infection, less post-operative pain, faster recovery time and no visible scars,” said Horst Neuhaus, M.D., Professor of Internal Medicine, Evangelisches Krankenhause Düsseldorf. He went on to say, “With this new endoscopic suturing platform, trained physicians can safely perform many procedures endoscopically, from inside, that previously would have required a more traditional surgical approach.”
Luigi Angrisani, M.D., President Elect for the International Federation of Surgery for Obesity (IFSO) indicated, “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.”
“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. Our efforts to improve patient care through less-invasive procedures will continue to highlight endoscopic surgery’s prominence in the world of healthcare,” Dennis McWilliams, President and CEO of Apollo Endosurgery said. “Apollo Endosurgery will continue to strive towards maintaining its leadership position as an innovator and a driving force in advancing this new class of less invasive therapies.”
Source: Apollo Endosurgery, Inc.