The FDA approved the investigational device exemption study to evaluate the device as a treatment for failing arteriovenous fistulas in end-stage renal disease patients.
“We are delighted to enroll and treat the 1st patient in this significant study of In.Pact AV Access DCB in patients with obstructed AV access,” principal investigator Dr. Jeffrey Hull said in prepared remarks. “Maintaining access patency is critical to delivering dialysis treatment, and for salvaging failing AV fistulas. Durable treatment options in these patients are limited.”
The IDE study is slated to enroll 330 patients and randomize them to receive either treatment with the In.Pact balloon or standard percutaneous transluminal angioplasty. The study’s primary efficacy endpoint is patency of dialysis fistulas through 6 months and the primary safety endpoint is serious adverse events through 30 days.
Millions of patients with end-stage renal disease undergo dialysis using an AV access site, but over time, thickening of the vessel walls limits the site’s accessibility. This can necessitate repeat intervention to open up the patient’s vessels.
“This important clinical study is designed to address the clinical need for new, innovative options for patients with limited AV access,” national principal investigator Dr. Robert Lookstein said. “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 this DCB’s use to improve patency and reduce the need for repeat interventions in AV access sites for patients on dialysis.”
“Through our ongoing dialogue with the clinical community, we recognize that maintaining patency at AV access sites for dialysis patients is a critical challenge,” Mark Pacyna, GM of Medtronic’s peripheral business, added. “Advancement of this study demonstrates our strong commitment to addressing challenging lesions and improving patient care in patients with ESRD.”