Seclusion Catheter

The Seclusion Catheter is a percutaneous catheter indicated for localized infusion and aspiration of therapeutic and diagnostic agents in isolated segments of the peripheral venous vasculature. It features two independently inflatable balloons to create a treatment zone and can be repositioned for multiple treatments on the same patient. The device is not indicated for neurovasculature use.

The Seclusion Catheter has a 4-lumen design with rounded tip, two 4–12 mm balloons inflated with air, 7 cm treatment zone length, compatibility with 0.014" and 0.018" guidewires, and a 7Fr sheath compatibility. It differs from the predicate (OPC) by having fewer lumens (4 vs 5), air rather than saline balloon inflation, a fixed 7 cm treatment length, and lacking the predicate's pressure sensing technology and center balloon.

Testing was based on FDA guidance for Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters (April 14, 2023). Biocompatibility testing followed ISO 10993-1 for an external communicating device with circulating blood contact for less than 24 hours.

The Seclusion Catheter is substantially equivalent because it shares the same indications for use (localized infusion/aspiration in peripheral venous vasculature with balloon-based treatment zone creation and repositionability), operates under the same regulatory pathway and product code (DQY, Class II), and demonstrates similar technological principles despite design differences. The functional differences (fewer lumens, air vs. saline inflation, lack of pressure sensing) do not raise new safety or effectiveness questions as the device meets the same performance requirements and underwent comparable testing for its intended peripheral venous application.