Vygon has obtained CE marking for Stiletto, its next-generation extended-dwell peripheral catheters equipped with SlipStream technology, the company announced in a press release this week. The CE marking and Medicines and Healthcare products Regulatory Agency (MHRA) authorisation 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 utilises the patented SlipStream insertion system, which was designed to replace the standard Seldinger technique used for this type of catheter. Vygon claims that, 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 healthcare 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 authorisations granted in the USA and Canada, obtaining CE and UKCA [UK Conformity Assessed] marking is the start of a new chapter for this intuitive technology aimed at enhancing vascular access practices in Europe.”
Vygon notes that this wire-free solution rounds out the company’s range of peripheral catheters to meet changing needs in terms of vascular access, both in Europe and internationally. “Demand is rising for reliable devices suitable for extended dwell, in particular due to an ageing population, with patients presenting with depleted venous access points and chronic conditions,” the company states.
In parallel, Vygon adds, 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 notes that it will make use of its existing sales structure (direct sales or distributors, depending on the country) to make Stiletto available to European healthcare providers.
