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International: Apollo Endosurgery Announces Positive Five Year Results from LAP-BAND®Pivotal Study Conducted With Lower BMI Patients

Wednesday, October 7, 2015 5:00 pm CDT
"This study confirms that the LAP-BAND® should be considered a treatment option for patients with a BMI as low as 30 to stop or slow the progression of Obesity and associated co-morbidities."

Apollo Endosurgery, Inc., a leader in minimally invasive endoscopic surgical products for bariatric and gastrointestinal procedures, today announced the results from a multicenter pivotal study detailing five-year health outcomes for LAP-BAND® patients with a BMI between 30-39.9.

  • The study showed sustained long term weight loss over the 5 year period. Average percent weight loss at five-years was 15.9 +/-12.4%, corresponding with 62.7% excess weight loss (EWL).
  • Patients showed significant improvement in their co-morbid conditions at the end of the 5 year period strengthening the previously released data of 85.7% improvement in diabetes, 64.4% improvement in dyslipidemia, and 59.6% improvement with hypertension.
  • No unanticipated adverse device events were reported.
  • The device explant rate was 14.8% which was substantially below the study’s safety objective of less than 32.5% at 5 years. Excluding patients who elected to exercise their option to have the band removed at no cost to them on completion of the study, the explant rate was 5.4% at 5 years.

“The LAP-BAND® System provides durable weight loss and significant improvements in pre-existing co-morbid conditions and quality of life,” said Professor Dixon, Study Co-Author and Head of Clinical Obesity Research at Baker IDI Heart and Diabetes Institute. “This study confirms that the LAP-BAND® should be considered a treatment option for patients with a BMI as low as 30 to stop or slow the progression of Obesity and associated co-morbidities.”

Dennis McWilliams, President and Chief Commercial Officer of Apollo Endosurgery added, “The LAP-BAND® AP System is safe and effective for patients with a BMI of 30 or higher, that delivers sustained weight loss, improvements in quality of life, and modest reduction in cardiometabolic risk when combined with reasonable and proper physician follow-up with their patient.”

About LAP-BAND® System

The LAP-BAND® System is placed laparoscopically in a minimally invasive procedure to assist in gradual weight loss. The LAP-BAND® System is fastened around the top of the stomach, and works by applying a constant, gentle pressure to this area. This gives you a feeling of satiety (a feeling of fullness) on a smaller amount of food, therefore you eat less.

For additional information regarding LAP-BAND®, please visit lapband.com/au.

For full safety information please talk with your doctor, or call Apollo Customer Support at 1-800-082-586.

About Apollo Endosurgery, Inc.

Apollo Endosurgery, Inc. is revolutionizing the treatment of obesity and other gastrointestinal disorders by developing less invasive solutions for a whole new group of patients not seeking treatment today. Apollo is a global innovator pushing boundaries to bring new technologies and innovative products to markets in over 80 countries today. In particular, Apollo’s bariatric products fill the gap between non-surgical weight loss solutions and invasive surgeries, allowing physicians to do more for those patients who require more than drug therapy and dietary advice. For more information regarding Apollo Endosurgery, go to: www.apolloendo.com.

 

Contact:

Media Contacts:
Amy O’Brien
Email: AmyO@thisismango.com.au
Phone: +61 3 9254 3618
Mobile: +61 417 342 575 Jennifer Cook
Email: jen.cook@apolloendo.com
Phone: 0011 1.512.279.5158

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