Apollo Endosurgery Inc (NASDAQ:APEN) disclosed that it has received FDA approval for its labeling updates for the ORBERA Intragastric Balloon System.
The Austin, Texas-based Apollo, which boasts a status as a global leader in less invasive medical devices for gastrointestinal and bariatric procedures, announced the nod Thursday. The goal of the labeling updates is to improve patient safety and these will take effect immediately.
The labeling updates improve patient safety by providing further definition and guidance on the appropriate use of the ORBERA® Intragastric Balloon System and patient selection. The most notable safety labeling updates included:
Clarification to contraindications. These changes clarified that the previous “hepatic insufficiency or cirrhosis” contraindication related to patients with acute liver failure and decompensated cirrhosis. The changes also clarified the types of previous gastric surgery that are contraindications.
Added precautions related to patients who are taking anti-cholinergic or psychotropic medications that are known to delay gastric emptying.
ORBERA® is an incision-less, non-surgical weight loss solution designed for adult patients suffering from obesity, who are not appropriate for or considering surgery, but for whom diet, and exercise or pharmaceutical interventions have not worked.
In a non-surgical (endoscopic) procedure, the thin and deflated ORBERA balloon is placed into the stomach. It is then filled with saline until it’s about the size of a grapefruit. The procedure typically takes about 20 minutes and the patient can generally go home a few hours later.
Shares in APEN nosed up eight cents, or 2.1%, to $3.83