Aqua Medical has received an investigational device exemption (IDE) from the FDA for its ablation device intended to treat diabetes, the company told MassDevice ahead of an official announcement later today.
The IDE gives the device developer the green light to conduct a pilot clinical trial of its Proximal Intestinal Mucosal Ablation (PIMA) procedure using its proprietary radiofrequency vapor ablation (RFVA) system.
PIMA, a minimally invasive outpatient endoscopic procedure, delivers circumferential ablation to 50-70 cm of the proximal intestine. It uses a simple, through-the-endoscope RFVA catheter with no incisions, fluoroscopy or anesthesia required. It aims to replicate the metabolic benefits of gastric bypass while avoiding the invasiveness of the procedure.
Aqua Medical’s RFVA system comprises of the Aqua RF Vapor Generator, Aqua RF Vapor Catheters, saline delivery tubing and syringe. The generator delivers bipolar RF energy to the single-use catheter, creating heated saline vapor in the catheter tip for ablation.
The Aqua Medical RFVA system is not for sale and not authorized for diabetes patients. However, it has FDA 510(k) clearance for coagulation and ablation of bleeding and non-bleeding sites in the gastrointestinal (GI) tract of adults. That includes but is not limited to the esophagus.
(Learn more about the Aqua Medical RFVA system and the PIMA procedure at Medical Design & Outsourcing.)
IDE approval means Aqua Medical can begin enrolling patients in its U.S. RESTORE-1 pilot trial. The study evaluates PIMA’s potential to deliver durable metabolic control for patients with type 2 diabetes without the need for surgery or chronic medications.
“I’ve worked collaboratively with Aqua Medical from the earliest duodenal ablation efforts through the development of the PIMA procedure,” Cleveland Clinic London Dr. Rehan Haidry said in a statement to MassDevice. “The through-the-scope RFVA catheter is elegant in its simplicity, and PIMA’s results to date are truly best-in-class — representing a major leap forward for metabolic endoscopy and the treatment of type 2 diabetes.”
Aqua tapped UNC School of Medicine professors Nicholas Shaheen and John Buse to co-lead RESTORE-1. The company supported its IDE submission with global data demonstrating safety and encouraging metabolic improvements.
Aqua Medical said its IDE submission was supported by global data demonstrating safety and encouraging metabolic improvements across multiple international sites. With IDE approval in place, the company is now preparing for U.S. site activation and patient enrollment.
“This IDE approval is a defining moment for Aqua Medical,” Aqua President and CEO Lloyd Mencinger told MassDevice ahead of the announcement. “It validates years of foundational research and global clinical experience, and opens the door to studying this important procedure in U.S. patients for the first time.”
The diabetes market has a range of technologies that help manage the chronic disease and Aqua Medical’s could provide another. The first of MassDevice’s Medtech Market Reports, now available for purchase, focuses on continuous glucose monitors (CGMs) for diabetes.
These in-depth reports provide exclusive data, forecasts, and expert analysis across key medtech sectors from medtech analysts. They help industry leaders make smarter strategic decisions. Learn more about purchasing the report here.
