MAGNIFICENT Trial Begins in Europe for Cardionovum's Legflow DCB to Treat SFA Disease

April 13, 2016—Cardionovum GmbH recently announced the enrollment of the first patient in the multicenter, randomized, controlled MAGNIFICENT clinical trial comparing the efficacy of the company’s Legflow drug-coated balloon (DCB) with conventional percutaneous transluminal angioplasty (PTA) in de novo or recurrent lesions in the superficial femoral artery (SFA) or popliteal segment. The trial will enroll 130 patients across multiple sites throughout Europe. The primary endpoint is the binary restenosis rate at 12 months determined by duplex ultrasonography. The trial’s Principal Investigator is Peter Goverde, MD, from the ZNA Stuivenberg hospital in Antwerp, Belgium.

In the company’s press release, Dr. Goverde commented, “We are very enthusiastic about starting the MAGNIFICENT trial, as the Legflow DCB has the potential to become the gold standard to replace conventional treatment in this indication. We congratulate Prof. Inge Fourneau, MD, at the UZ Leuven hospital in Belgium for enrolling the first patient.”

The Legflow is a paclitaxel-coated peripheral balloon dilatation catheter indicated for the treatment of critical limb ischemia, including de novo and restenotic lesions of the SFA, popliteal artery, and below-the-knee artery. It uses nanocrystalline paclitaxel particles of 0.1 µm in size, thus avoiding embolic or thrombotic effects and facilitating drug uptake in tissue. According to Cardionovum, the device’s Safepax coating enables consistent and predictable drug delivery to the lesion site, resulting in homogenous and maximized drug absorption into surrounding arterial tissue.

The company noted promising preliminary adjudicated 1-year results from the RAPID trial, which enrolled 160 patients with highly challenging intermediate and long lesions in the SFA who were randomized to either Legflow and stenting or standard PTA balloon and stenting.

Cardionovum’s products are not available for sale in the United States, advised the company.