FDA Oks Primary End Point For Lutonix Below-the-Knee Drug Coated Balloon

(RTTNews) - C. R. Bard Inc. (BCR) announced the U.S. Food and Drug Administration approved an Investigational Device Exemption or IDE supplemental application to modify the primary endpoint to a 6-month time point for the Lutonix 014 Drug Coated Balloon PTA Catheter or 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 or 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.

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.