Can Next-Gen Obesity Balloon Pump Confidence in Apollo?

Apollo Endosurgery's Orbera365 weight-loss balloon works the same way as the original Orbera device, except it is designed to stay in the patient's stomach for 12 months, twice as long as the previous version. Apollo Endosurgery said it has received CE Mark approval to sell its Orbera365 weight-loss system in Europe, doubling the amount of time the balloon stays inflated in the patient's stomach. The approval comes less than a month after FDA alerted doctors of patient deaths associated with obesity balloons made by Apollo and ReShape Medical. The news deflated Apollo's stock (NASDAQ: APEN), as shares sold off nearly 26% after FDA published the letter, but the Austin, TX-based company was quick to do damage control. Apollo defended the Orbera intragastric balloon during a conference call, noting that the device actually has a "very low mortality rate" of 0.01%. Originally, the Orbera balloon was removed from the patient's stomach after six months, but Orbera365 doubles the indwell period to 12 months, hence the name. Apollo said it will launch the new device in European countries where the CE Mark is recognized starting in the fourth quarter. The newer version of the balloon could potentially help patients achieve better weight loss results, according to Alfredo Genco, a professor at Sapienza University in Rome, Italy who has been treating obesity with Orbera since 1999. "In my experience the longer the treatment, the more weight patients tend to lose," Genco said. "Actu...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news