News | Drug-Eluting Balloons | January 18, 2016

IN.PACT Admiral DEB CE Marked for AV Access Treatment in End-Stage Renal Disease Patients

Drug-eluting balloon with 40 cm catheter enables physicians to maintain arteriovenous access in patients undergoing hemodialysis

Medtronic, CE Mark, IN.PACT Admiral DEB, arteriovenous AV access, hemodialysis, end-stage renal disease patients

January 18, 2016 — Medtronic plc announced that the IN.PACT Admiral drug eluting balloon (DEB) has received CE (Conformité Européene) Mark for arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease.

Globally, more than 2.5 million end-stage renal disease patients are undergoing hemodialysis, 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. However, thickening of the vessel walls and restenosis, due to repeated access for needed dialysis, can limit the ability to use and eventually shut down the dialysis access site. IN.PACT Admiral DEB aids in preventing restenosis, by opening the artery and delivering paclitaxel, an anti-proliferative agent, to the vessel wall. A new 40 centimeter catheter shaft will also be made commercially available in Europe under the expanded indication, which is specifically designed for AV access.

In the United States, IN.PACT Admiral DEB is approved to treat superficial femoral and popliteal arteries.

"For patients with hemodialysis, maintaining AV access is their lifeline to receiving the care they need to filter waste from their system. In the past, when the access site became stenosed, the only option was the use of a standard percutaneous transluminal angioplasty (PTA), which can result in the need for repeat procedures," said Konstantinos Katsanos, M.D., Ph.D., Guy's and St. Thomas' Hospital, London, United Kingdom. "The IN.PACT Admiral DEB, in my experience, provides a safe and more effective way of managing AV access by preventing vascular restenosis, improving patency of dialysis fistulas and grafts, and reducing the need of repeat PTA procedures."

The device is a clinically-proven, cost-effective primary endovascular therapy that enables physicians to treat claudication, restenosis and alleviate pain from superficial femoral artery (SFA) disease. The DCB's primary mode of action is physical dilatation of the vessel lumen by PTA, and the proven paclitaxel drug is intended to prevent artery narrowing by minimizing scar tissue formation.

For more information:

Related Content

Cardiovascular Systems Expands Product Portfolio for Peripheral and Coronary Interventions
News | Balloon Catheter | January 24, 2018
Cardiovascular Systems Inc. recently announced two new partnerships broadening the company’s product portfolio. CSI is...
Abbott recalls its NC Balloon catheters
News | Balloon Catheter | May 22, 2017
May 22, 2017 — Abbott Vascular has initiated a voluntary recall of specific lots of three catheters due to 19 reports
Videos | Balloon Catheter | November 16, 2016
A discussion with Todd Brinton, M.D., about the newly FDA-cleared Shockwave Medical Lithoplasty System, at the Transc
NuCryo Vascular, Next Generation Cryoplasty Inflation Device, PolarCath Balloon Dilatation System

PolarCath Balloon Dilatation System image courtesy of NuCryo Vascular

Technology | Balloon Catheter | March 28, 2016
NuCryo Vascular LLC announced the launch of the Next Generation Cryoplasty Inflation device. The device received U.S....
NuCryo Vascular, FDA clearance, next-gen, PolarCath System, cryoplasty inflation device
Technology | Balloon Catheter | January 12, 2016
NuCryo Vascular LLC announced that they have received U.S. Food and Drug Administration (FDA) 510(k) clearance on the...
Videos | Balloon Catheter | October 30, 2015
Todd Brinton, M.D., clinical associate professor and consulting associate professor of bioengineering at Stanford Uni
Overlay Init