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Obalon Touch Inflation System

FDA grants PMA-S Approval for Obalon Touch Inflation System

The Obalon Touch is intended to be commercialised in combination with the Obalon Navigation System, which is designed to eliminate the need for X-ray imaging during balloon placement

Obalon Therapeutics has gained approval of a Premarket Approval Supplement (PMA-S) application for the Obalon Touch Inflation System, an automated system utilized to inflate the Obalon Balloon, from the FDA.

The Obalon Touch is intended to be commercialised in combination with the Obalon Navigation System, which is designed to eliminate the need for X-ray imaging during balloon placement. A PMA-S application for the Obalon Navigation System was filed with the FDA in the third quarter of 2018 and is pending a decision by the FDA.    

“We are pleased to have received FDA approval of The Obalon Touch Inflation System,” said Amy VandenBerg, Vice President of Clinical and Regulatory Affairs. “Our near-term product pipeline is dedicated to further improving safety, reliability and ease of use of the Obalon Balloon System.”

The Obalon Balloon System is a swallowable intragastric balloon system indicated for temporary use to facilitate weight loss in adults with obesity (BMI30-40) who have failed to lose weight through diet and exercise. The System is intended to be used as an adjunct to a moderate intensity diet and behaviour modification programme.

The Obalon balloon system consists of a balloon folded inside a capsule that is swallowed by the patient, with no sedation or anaesthesia required. Once the balloon reaches the stomach, it is remotely inflated with gas via a micro-catheter that is then removed, leaving a lightweight, buoyant balloon in the stomach. Over the next three months of treatment, two additional balloons are swallowed and inflated. At the end of the six-month treatment period, all three balloons are removed via an outpatient endoscopy under conscious sedation.

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