Apollo Endosurgery provides update, clarity to FDA letter to providers
Apollo Endosurgery provided an update and clarifications to a letter the FDA sent to Health Care Providers dated August 10, 2017 relating to potential risks with liquid-filled intragastric balloons, including the company's ORBERA intragastric balloon system. In relation to the ORBERA balloon, the facts are: ORBERA is approved by the FDA as safe and effective in assisting adult patients suffering from obesity with a body mass index of 30 to 40 in losing and maintaining weight. There have been five reported deaths of patients who had received the ORBERA intragastric balloon in four different countries since ORBERA's FDA approval in August of 2015. Apollo self-reported all five cases to the FDA as part of its Global Product Surveillance program. The FDA's letter to Health Care Providers does not indicate that the patient deaths were related to the ORBERA device or the insertion procedures. While the cause of death has not been provided or determined in all cases, Apollo has not received any communication or indication from the attending physicians or hospitals that the deaths have been due to the ORBERA device. Apollo has received no product liability-related claims in connection with these five cases. As stated in the ORBERA Directions For Use, in the period from January 1, 2006 through March 31, 2017, there have been 21 reported deaths of patients while they had an ORBERA, which is an incident rate of less than one one-hundredth of one percent of the more than 277,000 ORBERA balloons distributed in the same time period. Since receiving FDA approval in August 2015, the incident rate remains less than 0.01%. ORBERA remains the only intragastric balloon that meets the American Society of Gastrointestinal Endoscopy's, or ASGE, threshold standards for the treatment of obesity. Todd Newton, CEO of Apollo states: "Patient safety is a key priority in everything we do at Apollo Endosurgery and we take adverse event reporting obligations related to our products very seriously. The FDA letter is an important reminder to the physician community that obesity is a serious disease and many obese patients are affected by one or more co-morbid conditions due to their obesity. In our physician training, we are diligent to emphasize the factors that support the safe and effective use of ORBERA and we will continue to do so."