CARDIONOVUM Announces Enrollment of First Patient in MAGNIFICENT Trial

CARDIONOVUM GmbH, a medical technology company developing and commercializing innovative medical devices such as drug-coated balloons and drug-eluting stents for the treatment of coronary and peripheral artery disease, announced the enrollment of the first patient in the MAGNIFICENT trial. 

The MAGNIFICENT study is a multi-center, randomized, controlled clinical trial comparing the efficacy of the 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 and is determined by duplex ultrasonography. 

Principal Investigator, Dr P. Goverde from the ZNA Stuivenberg hospital in Antwerp, Belgium, 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. Dr. Inge Fourneau at the UZ Leuven hospital in Belgium for enrolling the first patient.” 

MAGNIFICENT is registered on clinicaltrials.gov, NCT02710656. 

About Legflow® Drug-Coated Balloon 

Legflow is a paclitaxel-coated peripheral balloon dilatation catheter indicated for the treatment of critical limb ischemia; de-novo and restenotic lesions of the superficial femoral artery (SFA), popliteal artery, and below-the-knee (BTK) artery. The Legflow DCB delivers superior safety through the use of nanocrystalline paclitaxel particles of only 0.1μm in size, thus avoiding embolic or thrombotic effects and facilitating drug uptake in tissue. The SAFEPAX coating enables consistent and predictable drug delivery to the lesion site, resulting in homogenous and maximized drug absorption into surrounding arterial tissue. The RAPID trial randomized 160 patients with highly challenging intermediate and long lesions in the SFA to either Legflow and stenting or standard PTA balloon and stenting. Preliminary adjudicated results at 1 year showed very promising results in the Legflow group. More than 22,000 patients worldwide have been treated with the Legflow DCB.

Source: CARDIONOVUM GmbH