Regulatory

SYNDEO Medical Gains European MDR Approval for Two Product Brands

The SYNDEOPack Interventional Procedure Packs and Xssential Rapid Delivery Procedure Packs aim to improve procedural efficiency.

By: Michael Barbella

Managing Editor

Two flagship product brands from SYNDEO Medical—SYNDEOPack Interventional Procedure Packs and Xssential Rapid Delivery Procedure Packs—have earned European Medical Device Regulation (MDR) approval.

“We have observed over the years that the specialized interventional procedure pack market has seen a significant reduction in options as companies have consolidated or exited the segment,” SYNDEO Medical CEO A. Justin Lampropoulos said. “We believe our organization is uniquely positioned to fill this gap by delivering innovative, highly customizable solutions that address the specific needs of complex interventional procedures.”

The SYNDEOPack Interventional Procedure Packs and Xssential Rapid Delivery Procedure Packs are designed to improve procedural efficiency, providing a comprehensive, customizable selection of tools and a broad array of devices tailored to meet the demands of specialized interventional and surgical procedures.

“Our SYNDEOPack Interventional Procedure Packs and Xssential Rapid Delivery Procedure Packs are designed to include up to 80% of the essential products required for these procedures through our extensive interventional component portfolio, such as transradial sheaths, soft tissue biopsy devices, and drainage catheters,” Lampropoulos stated. “We believe that, when given the choice, supply chain executives and clinicians will prefer including these devices within their procedure packs rather than purchasing standalone items. This approach not only streamlines procedures by consolidating essential components but also delivers significant benefits in terms of cost savings, packaging reduction, and alignment with our sustainability goals.”

SYNDEO Medical designs, develops, and distributes fully integrated custom procedural solution products. Launched in 2023 by Lampropoulos and Andrew Cotton and headquartered in Belgium, SYNDEO Medical pushes the boundaries of healthcare innovation. Specializing in minimally invasive interventional and surgical products, SYNDEO Medical serves healthcare providers worldwide through a network of distribution partners and sales representatives.

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