ReShape Medical, Inc. Announces First US Procedure for FDA Approved ReShape Integrated Dual Balloon System
- Jaime Ponce from Chattanooga Bariatrics Performs First ReShape Procedure At Parkway Surgery Center (Ga.)
- Following FDA Approval, Company Focused on Physician Training and Expanding Access to Non-Surgical Weight Loss Procedure
SAN CLEMENTE, CALIF.—September 2, 2015—ReShape Medical® today announced that the first commercial U.S. patient has received the ReShape Integrated Dual Balloon System following its approval by the U.S. Food and Drug Administration (FDA) in July. ReShape provides a new option for adults with a BMI of 30-40 and a related health condition who haven’t succeeded at diet and exercise alone, and do not want or do not qualify for bariatric surgery. The approximately 20-minute non-surgical procedure, performed at Parkway Surgery Center (Ringgold, Ga.) by Dr. Jaime Ponce, is the first step of a 12-month program to promote a healthier lifestyle. Comprehensive dietary support and follow-up is done at Dr. Ponce’s Chattanooga Bariatrics office in Chattanooga Tenn., and is integrated into established bariatric patient management, offered to achieve successful weight loss. The ReShape Integrated Dual Balloon is becoming increasingly available as physicians and allied health professionals are trained on the procedure and support program to optimize patient outcomes.
“ReShape is working in partnership with physicians that have the skills and capabilities to help patients achieve their best results,” said Richard Thompson, President and CEO, ReShape Medical. “Patients can feel confident that ReShape providers will work with them to take advantage of all of the tools available in the 12-month program.”
The ReShape Procedure includes individual nutrition and exercise coaching from allied health professionals at the ReShape physician’s office, and access to the innovative ReShape Patient Portal that provides a unique experience as patients track their food intake, exercise and weight loss. The portal includes an online support community where patients can interact with each other and receive helpful tips and healthy recipes. ReShape also provides patients with support tools including a portion plate to kick start behavior modification, a wireless Fitbit® scale and a Fitbit activity tracker that automatically sync to the patient portal.
“The ReShape Integrated Dual Balloon offers a truly innovative and effective advancement in non-surgical weight loss options, but it is only part of the solution,” said Dr. Ponce. “With the dual balloon in place, participation in counseling and access to the support tools we provide are crucial to helping patients adjust their eating habits and adapt a healthier life style for long term success.”
About the ReShape Integrated Dual Balloon System
The ReShape Dual Balloon is a next generation technology designed to enhance performance in three important areas. First, two connected balloons have the largest fill volume available, taking up more space in the stomach than the old style single balloons. Second, it is designed for greater comfort by distributing the fill volume across two balloons, connected by a flexible shaft, which allows the device to conform to the natural shape of the stomach. Finally, the ReShape Integrated Dual Balloon is the only intragastric balloon that is designed to help prevent the migration of a deflated balloon from the stomach into the intestines.
In a U.S. randomized, sham control, double blinded study, patients that had the ReShape Procedure lost 2.3 times as much weight as a control group that received diet and exercise coaching only. There were also measurable and sustained improvements in co-morbidities and strong patient satisfaction. In a study of the ReShape Procedure in commercial use in Europe, ReShape patients on average lost 32 pounds, or 47% of their excess weight at six months and maintained 98% of their weight loss at one year.
About ReShape Medical, Inc.
ReShape Medical, Inc. is a medical device company focused on the development and commercialization of its dual intragastric balloon for weight loss. Driven by a passion to address the worldwide obesity epidemic, the company has developed a non-surgical alternative for obese patients seeking treatment. Additional company information can be found at www.ReShapeReady.com. The ReShape Procedure has been available in the European Union since December 2011.
About Chattanooga Bariatrics
Chattanooga Bariatrics is a bariatric practice in Chattanooga, Tenn. that specializes in surgical and non-surgical weight loss methods. For more information call 423-899-1000 or visit www.chattanoogabariatrics.com
Wendy Ryan/Rachel Gross
RESHAPE and the RESHAPE MEDICAL Logo are trademarks of ReShape Medical, Inc.
Fitbit® is a registered trademark of Fitbit Inc.