BD’s WavelinQ EndoAVF Is Evaluated in Postmarket Studies

April 29, 2021—BD (Becton, Dickinson and Company) announced that enrollment has begun and the first patients have been treated in the CONNECT-AV postmarket surveillance study.

According to BD, CONNECT-AV is a prospective, single-arm, open-label study that will follow patients treated with the WavelinQ EndoAVF system for 24 months.

The study’s dual primary effectiveness endpoints are the percentage of patients dialyzing using successful two-needle cannulation for at least 75% of the dialysis sessions over a continuous 28-day period at 6 months, and the subjects maintaining primary patency at 6 months.

The primary safety endpoint is freedom from device and procedure-related serious adverse events through 30 days. The trial is expected to enroll 280 patients in the United States.

“For more than 50 years, medicine has looked for a next-generation hemodialysis access procedure for patients with end-stage kidney disease that can truly change the treatment paradigm,” commented Brandon Repko, MD, in BD’s press release. “The CONNECT-AV trial is the next step in proving WavelinQ EndoAVF system’s role in 21st century [arteriovenous (AV)] fistula creation. My colleagues and I are thrilled to be a part of that patient care evolution.” Dr. Repko is Medical Director of Nuclear Imaging and Therapeutic Services at Butler Memorial Hospital in Butler, Pennsylvania. Dr. Repko treated the first patient in the CONNECT-AV trial in March 2021.

BD noted that CONNECT-AV is one of two postmarket studies of the WavelinQ EndoAVF system. The second study, WAVE-Global is a prospective, single-arm, open-label study that will follow patients treated with the WavelinQ EndoAVF system for 24 months.

The WAVE-Global primary endpoints are the number of interventions needed post creation to facilitate and/or maintain AV fistula use at 6 months, and the proportion of participants with freedom from Clinical Events Committee adjudicated device- or procedure-related serious adverse events at 30 days. The trial is expected to enroll 150 participants globally (outside of the United States).

“Physicians already have real-world experience using the WavelinQ EndoAVF system to create AV fistulas that make life-preserving hemodialysis possible,” stated Panagiotis M. Kitrou, MD, in the company’s announcement. Dr. Kitrou, who is principal investigator in the WAVE-Global study, continued, “Both of these studies will provide important long-term data on the safety and effectiveness of WavelinQ EndoAVF system to help make informed decisions about patient care.” Dr. Kitrou Assistant Professor in Interventional Radiology, Patras University Hospital in Patras, Greece. The first patient in the WAVE-Global trial was treated by Dr. Kitrou in December 2020 at Patras University Hospital.

The WavelinQ EndoAVF system’s 4-F low-profile increases anatomical fistula location options and enables additional venous wrist access points (ulnar vein or radial vein), providing increased procedural flexibility for physicians, while helping to reduce risk of scarring or arm disfigurement for patients compared to open surgical AV fistula creation, stated the company.