FDA OKs Aqua Medical IDE for Endoscopic Technology Trial

FDA has given investigational device exemption (IDE) approval for an Aqua Medical pilot clinical trial of its Proximal Intestinal Mucosal Ablation (PIMA) procedure using the company’s proprietary radiofrequency vapor ablation (RFVA) system. A company statement says FDA has already granted the system a breakthrough device designation to treat adults with uncontrolled Type 2 diabetes.

The statement says the IDE allows Aqua to begin enrolling patients in the RESTORE-1 pilot trial and study PIMA’s potential to deliver durable metabolic control for patients with Type 2 diabetes.

PIMA is described as a minimally invasive outpatient endoscopic procedure that delivers circumferential ablation to 50-70 cm of the proximal intestine using a through-the-endoscope RFVA catheter with no incisions or fluoroscopy required. Aqua says the procedure aims to replicate the metabolic benefits of gastric bypass while avoiding its invasiveness.