C. R. Bard Receives FDA Premarket Approval of the LUTONIX® 035 Drug Coated Balloon as the First & Only DCB for the Treatment...
August 28 2017 - 9:00AM
Business Wire
New Option to Preserve Vascular Access and
Help Hemodialysis Patients Extend Time Between
Reinterventions
C. R. Bard, Inc. (NYSE:BCR) today announced the LUTONIX® 035
Drug Coated Balloon PTA Catheter (DCB) has been granted premarket
approval (PMA) by the U.S. Food and Drug Administration (FDA) for a
new indication and is now available for sale in the United States.
With this approval, the LUTONIX® 035 DCB Catheter becomes the first
and only drug coated balloon that is FDA approved as safe and
effective in end stage renal disease (ESRD) patients with stenotic
lesions in dialysis arteriovenous (AV) fistulae. This latest
approval adds to the prior FDA indication of the LUTONIX® 035 DCB
Catheter for the treatment of superficial femoral artery (SFA) and
popliteal artery disease.
The FDA approval was based on the results of the LUTONIX® AV
Clinical Trial, the first investigational device exemption (IDE)
trial using drug coated balloons in patients with stenotic lesions
in AV fistulae. The follow-up results from randomized patients who
were treated with the LUTONIX® 035 DCB Catheter demonstrated safety
comparable to uncoated balloons.
The LUTONIX® 035 DCB Catheter also demonstrated a sustained
clinical benefit compared to conventional angioplasty through 12
months:
- 71.4% target lesion primary patency
(TLPP) at 180 days with superior results at 210 days (DCB 64.1% vs.
PTA 52.5%)
- 31.3% fewer reinterventions compared to
PTA at 6 months
- Nearly two (2) months more
reintervention-free days (217 days vs. 163 days) compared to
PTA
- 31.2% improvement in TLPP through 12
months
- 95% freedom from primary safety event,
indicating a consistent safety profile to PTA
Timothy M. Ring, chairman and chief executive officer,
commented, “This approval offers a new treatment option for
patients suffering from end-stage renal disease. In line with our
continued commitment to deliver products that improve patient care,
we are proud to extend the benefits of the LUTONIX® 035 DCB
Catheter to help preserve treatment options for U.S. patients.”
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 month,” said Scott O.
Trerotola, M.D., Stanley Baum Professor of Radiology, Associate
Chair and Chief, Interventional Radiology, Perelman School of
Medicine of the University of Pennsylvania and Principal
Investigator of the LUTONIX® AV Clinical Trial. “The LUTONIX® 035
DCB Catheter provides another option for physicians. It’s intended
to offer patients with end-stage renal disease fewer interruptions
in treatment and less time undergoing access maintenance,
potentially leading to improved patient satisfaction and quality of
life.”
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.
References
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 – National Kidney Foundation.
Available at: https://www.kidney.org/atoz/content/dialysisinfo
3 Vascular Access for Hemodialysis- National Institute of
Diabetes and Digestive and Kidney Diseases. Available at:
https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/hemodialysis/vascular-access
4 New Insights into Dialysis Vascular Access: Impact of
Preexisting Arterial and Venous Pathology on AVF and AVG Outcomes –
Clinical Journal of the American Society of Nephrology. Available
at:
https://www.researchgate.net/publication/305269023_New_Insights_into_Dialysis_Vascular_Access_Impact_of_Preexisting_Arterial_and_Venous_Pathology_on_AVF_and_AVG_Outcomes
C. R. Bard, Inc. (www.crbard.com),
headquartered in Murray Hill, NJ, is a leading multinational
developer, manufacturer and marketer of innovative, life-enhancing
medical technologies in the fields of vascular, urology, oncology
and surgical specialty products.
This press release may contain forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, which are based on management’s current expectations, the
accuracy of which is necessarily subject to risks and
uncertainties. These statements are not historical in nature and
use words such as “anticipate”, “estimate”, “expect”, “project”,
“intend”, “forecast”, “plan”, “believe”, and other words of similar
meaning in connection with any discussion of future operating or
financial performance. Many factors may cause actual results to
differ materially from anticipated results including product
developments, sales efforts, income tax matters, the outcomes of
contingencies such as legal proceedings, and other economic,
business, competitive and regulatory factors. The company
undertakes no obligation to update its forward-looking statements.
Please refer to the Cautionary Statement Regarding Forward-Looking
Information in our June 30, 2017 Form 10-Q for more detailed
information about these and other factors that may cause actual
results to differ materially from those expressed or implied.
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C. R. Bard, Inc.Investor Relations:Todd W.
Garner, 908-277-8065Vice President, Investor
RelationsorMedia Relations:Scott T. Lowry,
908-277-8365Vice President and Treasurer
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