- Apollo Endosurgery (NASDAQ:APEN) says its ORBERA device has proven to be safe over the years in clinical trials and since its approval by the FDA in August 2015.
- Since the FDA's OK, there have been five reported deaths in patients who received the ORBERA intragastric balloon in four countries, one in the U.S. The company reported all five cases under its Global Product Surveillance program. It says it has not received any communications or indications from physicians or hospitals that the deaths were due to ORBERA, adding that the FDA's letter did not indicate the deaths were related to the device. It has not received any product liability claims in connection with the five deaths.
- In the product's package insert, there have been 21 deaths in ORBERA patients in the period from January 1, 2006 through March 31, 2017, out of more than 277K devices distributed during the same period, an incident rate below 0.01%.
- CEO Todd Newton says, “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.”
- Management will host a conference call this morning at 8:30 am ET to review ORBERA's safety record.
- Shares sold off almost 26% yesterday after the FDA published a letter warning healthcare providers of the risks of liquid-filled intragastric balloons.
- Previously: Apollo Endo down 31% on FDA report of deaths in patients with Orbera System (Aug. 10)
- Now read: Concordia revenues down 31% in Q2
Original article