Vygon Receives CE Mark for Stiletto Extended-Dwell Peripheral Catheter
Vygon 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 United Kingdom, obtained in parallel, mean Vygon can commence the rollout of Stiletto in a number of European countries.
Acquired by Vygon from Avia Vascular in February 2026, Stiletto 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 uses the patented SlipStream insertion system, designed to replace the standard Seldinger technique for this type of catheter. By dispensing with metal guidewires and reducing the number of steps in the insertion procedure, SlipStream is intended to offer a simpler, more reliable technique with significant clinical benefits for patients.
The wire-free solution rounds out Vygon’s range of peripheral catheters and responds to rising demand for reliable devices suitable for extended dwell, particularly as an aging population presents with depleted venous access points and chronic conditions. Vygon noted that fewer professionals are being trained in the more complex standard insertion procedures, and that more straightforward, intuitive solutions can facilitate access to long-dwell vascular therapies while reducing reliance on frequent replacement of short peripheral catheters, where repeated needle sticks can deplete patients’ venous access points and negatively impact comfort. Vygon will use its existing sales structure, whether direct sales or distributors depending on the country, to make Stiletto available to European healthcare providers. The company cited a global market for midline and extended-dwell peripheral catheters worth more than $3 billion in 2024, expected to grow 6% to 9% annually between 2025 and 2030.
Ludovic Richard-Vitton, CEO of Vygon, said the introduction of Stiletto in Europe demonstrates the company’s commitment to safe innovation that meets the challenges healthcare professionals face. Richard-Vitton noted that Vygon aims to provide every caregiver with the most appropriate device, covering a variety of insertion and therapeutic needs precisely when they need it, and that following marketing authorizations granted in the United States and Canada, obtaining CE and UKCA marking marks the start of a new chapter for this technology aimed at enhancing vascular access practices in Europe.
