SYNDEO Medical has received certification under the European Union Medical Device Regulation (EU MDR) for its SATURN2 Rapid Inflation Device, allowing the company to market the product throughout Europe. The SATURN2 device is available in two pressure configurations—30 atmosphere and 40 atmosphere—and can be ordered with either a round or T handle. These options are designed to accommodate different procedural needs in interventional medicine.
The SATURN2 platform is intended for controlled and responsive inflation during various medical procedures. It is built for frequent use, featuring intuitive handling and mechanics that align with human biomechanics. This design aims to support efficient workflows in demanding clinical settings.
A. Justin Lampropoulos, CEO and Founder of SYNDEO Medical, commented on the approval: “This is a very significant commercial milestone for SYNDEO Medical. SATURN2 was engineered deliberately, feature by feature, with a genuine purpose behind every design decision. From the two shot trigger mechanism to the rapid inflation technology and the overall form and aesthetics of the device, nothing was incidental. We focused on how the device is actually used in real interventional settings and built SATURN2 to support efficiency, repeatability, and sustained use. The result is a rapid inflation device that serves as a versatile inflation device platform across multiple interventional procedures.”
The company plans to distribute SATURN2 through its global independent partners and select procedure pack producers across Europe. It will also be available for original equipment manufacturer collaborations. SYNDEO Medical will present the device at MD&M West conference in Anaheim, California from February 3 to 5, 2026.
