Becton, Dickinson and Company (BD) has treated the first subjects with the WavelinQ EndoAVF System in a post-market surveillance study to prove its role in arteriovenous (AV) fistula creation.
Using the WavelinQ EndoAVF System, doctors can create an AV fistula, for patients who require hemodialysis to survive, in a less invasive manner.
The system uses two thin, flexible, magnetic catheters and a burst of RF energy to make an endovascular AV fistula.
Its 4F, low profile builds anatomical fistula location options and permits extra venous wrist access points (ulnar vein or radial vein), giving expanded procedural flexibility to doctors, while aiding in lowering the risk of scarring or arm disfigurement for patients, which can be caused by open surgical AV fistula creation.
Named ‘CONNECT-AV’, the prospective, single-arm, open-label study will follow up the treated subjects for a duration of 24 months. BD plans to enrol 280 subjects in the study in the US.
The percentage of participants dialysing using successful two-needle cannulation for at least 75% of the dialysis sessions over a continuous 28-day period at six months and those maintaining primary patency at six months, will form the dual primary effectiveness endpoints of the study.
Freedom from device and procedure-related serious adverse events through 30 days will be the primary safety endpoint.
Another post-market study of the WavelinQ EndoAVF System, named ‘WAVE-Global’, has a similar study design as the CONNECT-AV study.
Its primary endpoints are the number of interventions required post-creation to aid and/or maintain AV fistula use at six months, as well as the proportion of subjects with freedom from Clinical Events Committee adjudicated device- or procedure-related serious adverse events at 30 days.
BD peripheral interventions medical and clinical affairs vice-president J D Meler said: “WavelinQ EndoAVF System represents a major advancement in AV fistula creation and offers physicians and their patients an innovative and minimally invasive alternative to surgical AV fistula creation, which can be associated with scarring and vessel trauma.
“As innovators in this space, the CONNECT-AV and WAVE-Global Studies are part of our ongoing effort to add data to help inform physicians, payors and regulators about the value and utility of the WavelinQ EndoAVF System and how it may benefit patients who require hemodialysis.”