Medtronic Enrolls First Patient in Study of IN.PACT(TM) AV Access Drug-Coated Balloon in Patients with End-Stage Renal Disease

VERITAS Vision System Is Introduced by Johnson & Johnson

The company will offer live demos of the new system in a wet lab at the Johnson & Johnson booth (#2813) this weekend at the 2021 American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators Annual Meeting.

GenesisCare Orders 27 Elekta Flexitron Treatment Devices

"GenesisCare continues to demonstrate its commitment to improving patient outcomes worldwide and Elekta is delighted to play a vital partnering role to achieve this mission," said Gustaf Salford, Elekta's President and CEO.

FoodMarble AIRE Shown to Exceed the Performance of ‘Gold Standard’ SIBO Testing in Clinical Trial

SIBO is a very common disorder where there are excessive bacteria present in the small intestine. The true prevalence of SIBO in the general population is largely unknown, with some studies estimating its occurrence in up to 15% of healthy individuals. It is also largely associated with many other common clinical conditions, including irritable bowel syndrome, where 40-80% of IBS patients have SIBO.

Jeffrey Hull, M.D., principal investigator at Richmond Vascular Center in Richmond, Va., states, “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,” concluded Hull.

Medtronic plc (NYSE: MDT) today announced that the first patient has been enrolled in the IN.PACT(TM) AV Access Drug-Coated Balloon (DCB) study for use in patients with end-stage renal disease (ESRD). The U.S. Food and Drug Administration (FDA) approved the investigational device exemption (IDE) study to evaluate the safety and efficacy of IN.PACT(TM) AV Access DCB as a treatment for failing arteriovenous (AV) fistulas in ESRD patients.

Jeffrey Hull, M.D., principal investigator at Richmond Vascular Center in Richmond, Va., states, “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,” concluded Hull.

Globally, more than 2.5 million patients with end-stage renal disease are undergoing dialysis,1 a procedure that filters waste and removes extra fluid from the blood when the kidneys are no longer healthy. AV access sites are used to provide hemodialysis to patients. Over time, thickening of the vessel walls limits the ability to use a dialysis access site, requiring repeat interventions to open up the vessels, which increase health care utilization and reduce quality of care. Repeated procedures are also associated with high technical failure rates and reduced quality of life for patients.2,3

“This important clinical study is designed to address the clinical need for new, innovative options for patients with limited AV access,” said Robert A. Lookstein, M.D., national principal investigator in the U.S. and professor of radiology and surgery, vice-chair of interventional services, and medical director of clinical supply chain at Mt. Sinai Healthcare System. “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.”

The IDE study will evaluate the safety and efficacy of the IN.PACT AV Access DCB for up to two years at approximately 30 sites in the United States, Japan, and New Zealand. In addition to Dr. Robert Lookstein, global principal investigators include: Andrew Holden, M.D., director of interventional radiology at Auckland Hospital and associate professor of radiology at Auckland University, and Hiroaki Haruguchi, M.D., clinic director at Haruguchi Vascular Clinic. The study will aim to enroll 330 patients with a 1:1 randomization to either treatment with IN.PACT(TM) AV Access DCB or standard PTA. The primary efficacy endpoint is patency of dialysis fistulas through six months and the primary safety endpoint is serious adverse events through 30 days.

“Through our ongoing dialogue with the clinical community, we recognize that maintaining patency at AV access sites for dialysis patients is a critical challenge,” said Mark Pacyna, general manager of the Peripheral business, which is part of the Aortic & Peripheral Vascular division at Medtronic. “Advancement of this study demonstrates our strong commitment to addressing challenging lesions and improving patient care in patients with ESRD.”

The IN.PACT AV Access DCB is based on the IN.PACT Admiral DCB technology. The IN.PACT Admiral DCB is FDA approved to treat patients with PAD in the upper leg.

IN.PACT AV Access is an Investigational Device and is not FDA approved for sale in the United States.

spot_img

DON'T MISS

Our Sister Publication: Biotechnology News Magazine

Subscribe to Medical Device News Magazine here.