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FDA Approves 6-Month Primary End Point for the Lutonix® Below-the-Knee Drug Coated Balloon

Life Science Investing News

C. R. Bard, Inc. (NYSE: BCR) announced the USFDA approval of 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).

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
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operating or financial performance. Many factors may cause actual
results to differ materially from anticipated results including product
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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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