FDA approves six-month primary endpoint for the Lutonix below-the-knee drug-coated balloon

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The US Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) supplemental application to modify the primary endpoint to a six-month time point for Bard’s Lutonix 014 drug-coated balloon percutaneous transluminal angioplasty catheter. Bard says that the Lutonix 014 device is currently the only drug-coated balloon in an IDE clinical trial in the USA for treatment of arteries below the knee.

The clinical trial is evaluating the device when used for the treatment of stenosis or occlusion of native below-the-knee arteries with a cumulative lesion length up to 320mm with reference vessel diameters of 2–4mm. Currently, the study has enrolled approximately 340 patients, of which 69% are diabetic, 33% are female, and 95% have critical limb ischaemia. The primary safety endpoint 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 six 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—the first drug-coated balloon approved in the USA—the Lutonix 014 is an angioplasty balloon that is coated with a low dose of the drug paclitaxel, and also utilises standard mechanical dilatation of the vessel to restore blood flow for patients with peripheral artery disease. The Lutonix 035 is also the only drug-coated balloon being evaluated in an IDE trial for the treatment of dysfunctional arteriovenous fistulae located in the upper extremity, a Bard press release notes.

“Below-the-knee peripheral artery disease 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 Michael R Jaff, medical director of VasCore, the vascular ultrasound core laboratory used in the Lutonix BTK trial.

“A significant number of patients with below-the-knee disease are at risk of limb loss and would be expected to benefit from alternative treatment options. The Lutonix 014 drug-coated balloon 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 below-the-knee vessels,” said Jihad Mustapha, Lutonix BTK principal investigator.

The Lutonix 014 has been available commercially in Europe since 2013 and is available in most geographies outside the USA. In the USA, the Lutonix 014 is currently an investigational device limited by US law to investigational use.