FDA Approves 6-Month Primary End Point for the Lutonix® Below-the-Knee Drug Coated Balloon
September 19 2016 - 4:37PM
Business Wire
C. R. Bard, Inc. (NYSE: BCR) today announced the U.S. Food and
Drug Administration (FDA) approved an Investigational Device
Exemption (IDE) supplemental application to modify the primary
endpoint to a 6-month time point for the Lutonix® 014 Drug Coated
Balloon PTA Catheter (DCB). The Lutonix® 014 device is currently
the only DCB in an IDE clinical trial in the U.S. for treatment of
arteries below the knee (BTK).
The clinical trial is evaluating the device when used for the
treatment of stenosis or occlusion of native BTK arteries with a
cumulative lesion length up to 320 mm with reference vessel
diameters of 2 to 4 mm. Currently, the study has enrolled
approximately 340 patients, of which 69% are diabetic, 33% are
female, and 95% have critical limb ischemia (CLI). The primary
safety end point in the study is freedom from major adverse limb
event or postoperative death at 30 days and the primary efficacy
end point is a composite of limb salvage and primary patency at 6
months. An independent data monitoring committee, which is
chartered to review patient safety for the study, has met for the
tenth time and unanimously recommended continuation of the study
with no modifications.
Similar to the Lutonix® 035 DCB, the first drug coated balloon
approved in the U.S., the Lutonix® 014 DCB is an angioplasty
balloon that is coated with a low dose of the drug paclitaxel, and
also utilizes standard mechanical dilatation of the vessel to
restore blood flow for patients with peripheral arterial disease
(PAD). The Lutonix® 035 DCB is also the only DCB being evaluated in
an IDE trial for the treatment of dysfunctional arteriovenous
fistulae located in the upper extremity.
PAD is estimated to be present in 3% of people in the age range
of 40 to 59 years and in 20% of people over 70 years1 of age. The
majority of patients undergoing BTK interventions suffer from CLI
with high cardiovascular risk and often significant medical
co-morbidities. CLI is typically defined as limb pain that occurs
at rest (Rutherford Category 4)2, or impending limb loss that is
caused by severely compromised blood flow to the affected extremity
leading to non-healing ulcers (Rutherford Category 5 and 6).
“Below the knee PAD is a challenging disease in a patient group
that is currently under served. Patients often have to undergo
frequent reinterventions following initial treatment. Regular
balloon angioplasty is the primary catheter-based treatment option
available today” said Dr. Michael R. Jaff, Medical Director of
VasCore, the vascular ultrasound core laboratory used in the
Lutonix® BTK trial.
“A significant number of patients with BTK disease are at risk
of limb loss and would be expected to benefit from alternative
treatment options. The Lutonix® 014 DCB could offer physicians an
opportunity to change the treatment paradigm for patients by
providing a safe and effective method to deliver paclitaxel
directly to stenosed BTK vessels,” said Jihad Mustapha, M.D.,
Lutonix® BTK Principal Investigator.
The Lutonix® 014 DCB has been available commercially in Europe
since 2013 and is available in most geographies outside the U.S. In
the U.S., the Lutonix® 014 DCB is currently an investigational
device limited by U.S. law to investigational use.
1
Zeller, T. Current state of endovascular
treatment of femoro-popliteal artery disease. Vas Med 12 (2007):
223-234.
2
Rutherford RB, Baker JD, Ernst C, Johnston
KW, Porter JM, Ahn S, et al. Recommended standards for reports
dealing with lower extremity ischemia: revised version. J Vasc Surg
1997; 26:517-38.
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, 2016 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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