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

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.

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.
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