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Aqua Medical Receives the US FDA IDE Approval to Initiate Trial for Ablation Procedure to Treat Uncontrolled Type 2 Diabetes

Shots:

  • Aqua Medical has received the US FDA IDE approval to initiate the RESTORE-1 study evaluating the Proximal Intestinal Mucosal Ablation (PIMA) procedure using its radiofrequency vapor ablation (RFVA) system in adults with uncontrolled type 2 diabetes
  • The IDE approval was backed by international data showing safety & metabolic benefits of PIMA, allowing Aqua Medical to prepare for US site activation & patient enrollment
  • PIMA is a minimally invasive, outpatient endoscopic procedure that uses a through-the-endoscope RFVA catheter to ablate 50–70 cm of the proximal intestine, aiming to replicate gastric bypass metabolic benefits without surgery or fluoroscopy

Ref: PRNewsWire | Image: Aqua Medical | Press Release

Related News:- Pulse Biosciences Receives FDA IDE Approval for nsPFA Cardiac Surgery System to Treat Atrial Fibrillation

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