A new intravenous anesthesia delivery technique used during endothermal ablation for varicose veins demonstrated comparatively low pain scores according to first-in-human (FIH) data recently presented at the 2023 VEITHsymposium.
The investigational Solutio catheter (MedVasc), which contains both a bent needle for tumescence deployment through the vessel wall into the perivascular space and endothermic fiber for ablation treatment, produced a median score of 5 (0–24) on the visual analogue scale (VAS) in nine consecutive patients in Sweden, Michael Åkesson, MD, an interventional radiologist and developer of the device, told the New York City gathering (Nov. 14–18).
He hailed the catheter as a safe and feasible solution resulting in a single puncture as opposed to several.
Traditionally, Åkesson observed, patients find the anesthesia part of the ablation treatment process unpleasant, with VAS pain scores often varying from 20–60.
Results from the FIH study showed two “mild” device deficiencies and no serious adverse events. Patients—eight women and one man—underwent treatment by a single vascular surgeon. They were recorded as having a great saphenous vein median length of 41cm.
“The subject with the 24 VAS score reported that the pain came from the puncture site area in the lower leg,” Åkesson, a researcher attached to Lund University in Lund, Sweden, told VEITH 2023. “The surgeon suspected this was caused by a dissection while accessing the vein. He generally considered the catheter to be safe and easy to use, but with a short learning curve. Two minor device-related defects were reported—low flow rate in the long needle and catheter with high friction while pushing the needle out of the catheter. Both problems will be resolved with the prototype.”
During the four-week follow-up period following treatment, no serious adverse events emerged and no signs of bleeding were reported, Åkesson added.
