FDA Clears Imricor Medical’s Vision-MR Diagnostic Catheter

Imricor Medical Systems Inc. has secured U.S. Food and Drug Administration (FDA) 510(k) clearance for its Vision-MR Diagnostic Catheter under the premarket notification process. It is the company’s first FDA clearance.

The Vision-MR Diagnostic catheter is designed to be used under real-time magnetic resonance imaging (MRI) guidance and represents a key component of Imricor’s platform of MRI-compatible electrophysiology (EP) devices. The authorization from the FDA allows Imricor to commercially market the Vision-MR Diagnostic Catheter in the United States, the world’s largest electrophysiology market.

“This is obviously a tremendous milestone for the Imricor team, and I want to acknowledge the outstanding work of the entire team in reaching this achievement,” Imricor Chairman/CEO Steve Wedan said. “Most of us have worked at companies that have existing medical devices on the U.S. market, and getting a new device on the market is always a big deal. But getting a company’s first device on the U.S. market is an extraordinarily big deal. It’s an exciting achievement and a date to be noted and remembered.”

The Vision-MR Ablation Catheter is Imricor’s prime product offering, specifically designed to work under real-time MRI guidance, with the intent of enabling higher success rates along with a faster and safer treatment compared to conventional procedures using X-ray guided catheters. The Vision-MR Ablation Catheter has been approved in the European Union with an indication for treating type 1 atrial flutter. Imricor intends to seek approval for expanded indications in the future. The company is also in the early stages of pursuing the required regulatory approvals to place its key products on the market in Australia and the United States.

The Company has received approval from European regulators to sell the Advantage-MR EP Recorder/Stimulator System and its consumable product, the Vision-MR Dispersive Electrode.

Imricor Medical Systems develops MRI-compatible medical devices that can be used to carry out MRI-guided cardiac catheter ablation procedures. Headquartered in Burnsville, Minn., Imricor claims to be the world’s first company to bring commercially viable and safe MRI-compatible products to the cardiac catheter ablation market.