Holy Name Medical Center Enrolls Its First Patient in Medtronic's IN.PACT AV Access DCB Study
July 19, 2017—Holy Name Medical Center in Teaneck, New Jersey, recently announced that it has enrolled the center's first patient in the IN.PACT Arteriovenous (AV) Access Drug-Coated Balloon (DCB) study, which is evaluating the safety and efficacy of Medtronic's In.Pact AV Access DCB as a treatment for failing AV fistulas in patients with end-stage renal disease.
In May, Medtronic announced the commencement of enrollment in the study at the Richmond Vascular Center in Richmond, Virginia. The Medtronic-sponsored study will be conducted for up to 2 years at approximately 30 sites in the United States, Japan, and New Zealand. The study is being conducted under a US Food and Drug Administration (FDA) investigational device exemption. The study will aim to enroll 330 patients with a 1:1 randomization to treatment with either the In.Pact AV Access DCB or standard percutaneous transluminal angioplasty. The primary efficacy endpoint is patency of dialysis fistulas through 6 months and the primary safety endpoint is serious adverse events through 30 days.
Interventional radiologist Vincent Gallo, MD, is the Principal Investigator at Holy Name Medical Center for the study. In Holy Name's press release, Dr. Gallo commented, “Maintaining patency at AV access sites is critical to effectively delivering dialysis treatment, and we are delighted to enroll and treat the first patient at our center in this significant study designed to address the clinical need for new, innovative options for patients with limited AV access. DCBs are supported by clinical evidence in patients with peripheral artery disease in the upper leg. We hope that this study may provide data to support the use of In.Pact AV Access DCB to improve patency and reduce the need for repeat interventions with patients on dialysis.”
As noted by Holy Name Medical Center, Medtronic's In.Pact AV Access DCB is based on the company's In.Pact Admiral DCB technology. The In.Pact Admiral DCB is FDA approved to treat patients with peripheral artery disease in the upper leg. In.Pact AV Access is an investigational device and is not approved for sale in the United States.