Tuesday, 02 January 2024 12:17 GMT

Vygon obtains CE marking for its Stiletto next-generation extended-dwell peripheral catheter


Date:

(MENAFN- ALA Group) With UKCA marking for United Kingdom obtained in parallel, Vygon achieves milestone in European rollout of Stiletto®, a solution that responds to evolving vascular access practices and practitioners’ increasing need for longer-dwell access

Ecouen, France, October 28, 2026 – Vygon, an international specialist in the design, manufacture and distribution of medical devices, today announces it has obtained CE marking for Stiletto®, its next-generation extended-dwell peripheral catheters equipped with SlipStream technology. The CE marking and the MHRA (Medicines and Healthcare products Regulatory Agency) authorization for the UK, obtained in parallel, mean that Vygon can commence the rollout of Stiletto in a number of European countries.

Acquired by Vygon from Avia Vascular in February 2026, the Stiletto extended-dwell catheter is a sterile, single-use catheter for peripheral vein insertion, designed for courses of treatment with an average duration of less than 28 days. It utilizes the patented SlipStream™ insertion system, which was designed to replace the standard Seldinger technique used for this type of catheter. By dispensing with metal guidewires and reducing the number of steps in the insertion procedure, SlipStream offers a simpler, more reliable technique that brings with it significant clinical benefits for patients.

“The introduction of Stiletto in Europe demonstrates our commitment to safe innovation that meets the challenges health care professionals are facing. Our aim is to provide each and every caregiver with the most appropriate device, covering a variety of insertion and therapeutic needs, precisely when they need it,” said Ludovic Richard-Vitton, CEO of Vygon. “Following on from the marketing authorizations granted in the United States and Canada, obtaining CE and UKCA marking is the start of a new chapter for this intuitive technology aimed at enhancing vascular access practices in Europe.”

This wire-free solution rounds out Vygon’s range of peripheral catheters to meet the changing needs in terms of vascular access, in Europe and internationally. Demand is rising for reliable devices suitable for extended dwell, in particular due to an aging population, with patients presenting with depleted venous access points and chronic conditions.

In parallel, fewer and fewer professionals are being trained in the more complex standard insertion procedures. In light of this, more straightforward and intuitive solutions can facilitate access to these long-dwell vascular therapies and reduce reliance on the frequent replacement of short peripheral catheters, where repeated needle sticks can deplete patients’ venous access points and negatively impact their comfort throughout their care journey.

Vygon will make use of its existing sales structure (direct sales or distributors, depending on the country) to make Stiletto available to European health care providers.

The global market for midline and extended-dwell peripheral catheters was worth more than $3 billion in 2024 and is expected to grow by 6% to 9% a year between 2025 and 2030. The extended-dwell peripheral catheter segment is particularly buoyant, thanks to the growing need for venous access solutions for treatment lasting up to 28 days that combine clinical efficacy with safety and profitability.

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ALA Group

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