Phlebogriffe – a new device for mechanochemical ablation of incompetent saphenous veins: a pilot study

Objectives: The aim of this study was to evaluate the feasibility, safety and early results of mechanochemical ablation of incompetent varicose veins using a special catheter: the Phlebogriffe.

Material and methods: The design of this catheter is based on a typical diagnostic catheter. Into this catheter a metal shank, attached to which are 5 thin, curved, springy wires with sharpened ends, is introduced. After being pushed out of the catheter, these wires deploy into a cat’s claw pattern. When the whole device – the catheter and shank with open claws – is being pulled out, sclerosing foam is administered. In this pilot study, which was performed in the years 2011-2013, we evaluated 40 patients with varicose veins. Efficacy of the procedure, defined as closure of the treated vein, and clinical result evaluated using the Venous Clinical Severity Score (VCSS) were assessed after 1, 3, 6 and 12 months.

Results: Efficacy of the procedure after 1, 3, 6 and 12 months was 97.4%, 94.9%, 89.7% and 89.7%, respectively. Statistical analysis of the VCSS before the procedure and after 12 months revealed statistically significant improvements regarding pain, presence of varicose veins, oedema, number and size of active ulcers, their duration, size of active ulcers and the use of compression therapy. The average improvement in VCSS scores was 3.56 points.

Conclusions: The Phlebogriffe is a device that offers new opportunities for safe and efficient treatment of varicose veins associated with incompetence of saphenous veins.