Apollo Endosurgery Announces FDA Approval of Revised Labeling for the ORBERA® Intragastric Balloon System
AUSTIN, Texas -Apollo Endosurgery, Inc. (“Apollo”) (Nasdaq: APEN) a global leader in less invasive medical devices for bariatric and gastrointestinal procedures, announced today that the United States Food and Drug Administration (FDA) has approved updates to the ORBERA® Intragastric Balloon System’s U.S. labeling including a new Physician Directions for Use (DFU), Physician Training, and Patient Directions for Use. Apollo, working directly with the Food and Drug Administration, has developed these updates as a means of communicating ORBERA’s most current safety information to both physicians and patients. Today’s Letter to Healthcare Providers issued by the FDA is intended to highlight the updated labeling. The new DFU is available to physicians and patients at www.apolloendo.com/patient-labeling-and-dfus/.
Apollo’s last ORBERA labeling update occurred on June 6, 2017 and included information regarding adverse events of acute pancreatitis and spontaneous hyperinflation, which were not seen during the ORBERA United States pivotal study. The newly revised and approved labeling announced today provides updates for these two events and also adds information regarding the risks of gastric and esophageal perforation, aspiration, and death. The table below summarizes the global rate of occurrence for these adverse events as included in the revised DFU (data as of March 31, 2018) and in the previous DFU (data as of March 31, 2017).
Global Rate (as
Global Rate (as
Also included in this DFU update are specific U.S. rates for acute pancreatitis, spontaneous hyperinflation, gastric and esophageal perforation, and aspiration. The newly approved DFU also separately reports a U.S. mortality rate in ORBERA patients of 0.036% (i.e. less than 4 deaths per 10,000 patients) to provide additional awareness to U.S. physicians and patients.
The table below provides mortality rates for procedures performed in gastrointestinal and bariatric medicine as reported in peer-review literature. The mortality rate of a colonoscopy, which is the most common procedure performed in gastrointestinal medicine, is in line with that of ORBERA. It is also important to understand that colonoscopies are generally performed as a screening procedure, while ORBERA is an actual treatment procedure.
Laparoscopic Gastric Banding
Laparoscopic Sleeve Gastrectomy
The U.S. Physician Training has also been revised and approved by the FDA. The updated training provides additional guidance on management of ORBERA patients experiencing symptoms suggestive of persistent intolerance (identified as “refractory intolerance” in the revised labeling). While infrequent in occurrence, these patients can develop an intolerance to the balloon potentially caused by a greater than anticipated delay in gastric emptying with gastric distention and retention of food and fluid. These patients may be at greater risk for both perforation and aspiration at the time of balloon removal.
To help physicians recognize the signs and symptoms of persistent intolerance, and appropriately manage these patients, updated training has been developed to provide:
- more detailed descriptions of the symptomology of persistent intolerance,
- methods of assessing these patients and
- updated recommendations for the management of symptoms and removal of the device.
These updates will be incorporated into the patient labeling, physician labeling and physician training. All previously trained physicians will also receive this new training.
”These updates provide important enhancements to our existing labeling and support our continued emphasis on patient safety. Physicians should always monitor patients closely during the entire term of treatment, and patients should be thoroughly instructed on signs or symptoms of potentially life-threatening adverse events,” said Christopher Gostout, MD, Chief Medical Officer at Apollo Endosurgery.
World-wide, four (4) occurrences of death in patients who received the ORBERA Intragastric Balloon have been reported since the FDA’s “Updated Letter to Healthcare Providers” dated August 10, 2017. One (1) of these four (4) reported events occurred in the U.S. since the FDA’s August 2017 update. In analyzing the information available for these four (4) reports, gastric perforation preceded three (3) of the deaths including the U.S. event reported on 1/12/18. The table below provides summary information regarding these reports as well as access to the full MedWatch reports via a direct link to the FDA’s MAUDE database:
|Location||Event Date||Reported Date||Link to FDA MAUDE Data|
In each case, Apollo provided the event report to FDA through the MedWatch system and, per Apollo’s standard procedures, exhausted all efforts to obtain information directly from the treating physicians. In the absence of information that clearly states the ORBERA did not cause or contribute to the adverse event, Apollo’s standard procedure is to report the events through MedWatch.
ORBERA® is an incision-less, non-surgical weight loss solution designed for adult patients suffering from obesity, who are not appropriate for or considering invasive 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 to 30 minutes and the patient can generally go home the same day. At six months, through another non-surgical procedure, the ORBERA balloon is deflated and then removed.
Once the balloon is in place, the patient receives an individually tailored support program through the ORBERA Managed Weight Loss System team of experts to help keep them motivated, coordinate their program and help them work through weight loss barriers to meet their long-term weight loss goals. Coaching takes place over 12 months, even though the balloon is removed after six months. The program is designed to help the patient develop sustainable, healthy habits that will help keep weight off over time.
For more than 20 years, the global medical community has been using intragastric balloons from the makers of ORBERA to help thousands of people lose weight. More than 295,000 ORBERA balloons have been distributed worldwide in over 70 countries.
For additional information regarding ORBERA, please visit www.orbera.com.
For full safety information please visit www.orbera.com/dfu, talk with your doctor, or call Apollo Customer Support at 1-855-MYORBERA.
About Apollo Endosurgery, Inc.
Apollo Endosurgery, Inc. is a medical device company focused on less invasive therapies for the treatment of obesity, a condition facing over 600 million people globally, as well as other gastrointestinal conditions. Apollo’s device based therapies are an alternative to invasive surgical procedures, thus lowering complication rates and reducing total healthcare costs. Apollo’s products are offered in over 70 countries today and include the OverStitch™ Endoscopic Suturing System, the ORBERA® Intragastric Balloon, and the LAP-BAND® Adjustable Gastric Banding System.
Apollo’s common stock is traded on Nasdaq Global Market under the symbol “APEN.” For more information regarding Apollo, go to: www.apolloendo.com.
© 2018 Apollo Endosurgery, Inc. All rights reserved. Any third-party trademarks used herein are the property of their respective owners.
Cautionary Note on Forward-Looking Statements
Certain statements in this press release are forward-looking statements that are subject to risks and uncertainties that could cause results to be materially different than expectations. Important factors that could cause actual results to differ materially include: reports of adverse events related to our products, developments in medical technology, regulatory approvals and extensive regulatory oversight by the FDA or other regulatory bodies, unfavorable media coverage related to our products or related procedures, reimbursement decisions by private or government payors, physician adoption and recommendations of procedures utilizing our products and other factors detailed from time to time in the reports Apollo files with the Securities and Exchange Commission, or SEC, including its Form 10-K for the year ended December 31, 2017 and it Form 10-Q for the three months ended March 31, 2018. Copies of reports filed with the SEC are posted on Apollo’s website and are available from Apollo without charge. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Apollo disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.