Medtronic Commences IDE Study of In.Pact AV Access DCB in Patients With End-Stage Renal Disease
May 24, 2017—Medtronic announced that the first patient has been enrolled in a study of the company's In.Pact AV Access drug-coated balloon (DCB) under a US Food and Drug Administration (FDA) investigational device exemption (IDE). The study will evaluate the safety and efficacy of the device as a treatment for failing arteriovenous (AV) fistulas in patients with end-stage renal disease.
According to Medtronic, the IDE study will assess the safety and efficacy of the In.Pact AV Access DCB for up to 2 years at approximately 30 sites in the United States, Japan, and New Zealand. The study will aim to enroll 330 patients with a 1:1 randomization to either treatment with 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.
The first patient was treated by Jeffrey Hull, MD, Principal Investigator at Richmond Vascular Center in Richmond, Virginia. Dr. Hull commented in the company's announcement, "We are delighted to enroll and treat the first patient in this significant study of In.Pact AV Access DCB in patients with obstructed AV access. Maintaining access patency is critical to delivering dialysis treatment and for salvaging failing AV fistulas. Durable treatment options in these patients are limited."
Robert A. Lookstein, MD, who is the trial's National Principal Investigator in the United States, stated, "This important clinical study is 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 (PAD) 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." Dr. Lookstein is Professor of Radiology and Surgery, Vice Chair of interventional services, and Medical Director of Clinical Supply Chain at Mt. Sinai Healthcare System in New York, New York.
In addition to Dr. Lookstein, the trial's Global Principal Investigators include Andrew Holden, MD, Director of Interventional Radiology at Auckland Hospital and Associate Professor of Radiology at Auckland University in Auckland, New Zealand; and Hiroaki Haruguchi, MD, Clinic Director at Haruguchi Vascular Clinic in Tokyo, Japan.
The In.Pact AV Access DCB is based on the In.Pact Admiral DCB technology, which is FDA approved to treat patients with PAD in the upper leg. The In.Pact AV Access is an investigational device and is not approved for sale in the United States, advised Medtronic.