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|C. R. Bard Receives FDA Premarket Approval of the LUTONIX® 035 Drug Coated Balloon as the First and Only DCB for the Treatment of Patients with Dysfunctional AV Fistulae|
New Option to Preserve Vascular Access and Help Hemodialysis Patients Extend Time Between Reinterventions
The LUTONIX® 035 DCB Catheter also demonstrated a sustained clinical benefit compared to conventional angioplasty through 12 months:
Globally, there are more than 2 million patients undergoing hemodialysis treatments¹ – each therapy session lasting approximately four hours and occurring up to three times per week – in a hospital or dialysis center.² To receive this therapy, many patients depend on an AV fistula³, which is the connection of an artery to a vein created by a vascular surgeon. For these patients, blockages created by repeated access or narrowing of the blood vessel (restenosis) are a common problem and hinder treatment. Some patients require up to eight reinterventions per year to maintain AV fistula function⁴, their lifeline for managing renal disease.
“For patients undergoing hemodialysis for kidney failure – who already
spend a significant portion of their time undergoing dialysis and other
treatments – repeated reinterventions to maintain AV access can be an
added burden, with many patients returning as frequently as every other
About the LUTONIX® AV Clinical Trial
The LUTONIX® AV Clinical Trial included 285 subjects with lesion locations ranging from AV anastomoses at the wrist to the axillosubclavian junction at the shoulder. The trial design incorporated core laboratory evaluations on all patients, monitoring of all data points, independent Clinical Events Committee (CEC) adjudication and Data and Safety Monitoring Board (DSMB) review.
The two-year study is ongoing with additional endpoints at 18 and 24 months.
About the LUTONIX® 035 DCB Catheter
The LUTONIX® 035 Drug Coated Balloon PTA Catheter (DCB) is an angioplasty balloon coated with a therapeutic dose of the drug paclitaxel. The new indication is for percutaneous transluminal angioplasty (PTA) in stenotic lesions of dysfunctional native arteriovenous (AV) dialysis ﬁstulae that are 4 mm to 12 mm in diameter and up to 80 mm in length.
1 ESRD Patients in 2013: A Global Perspective – Fresenius Medical Care. Available at: http://www.vision-fmc.com/files/ESRD_Patients_in_2013.pdf
2 A to Z Health Guide: Dialysis –
3 Vascular Access for
4 New Insights into Dialysis Vascular Access: Impact of
Preexisting Arterial and Venous Pathology on AVF and AVG Outcomes –
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