CARDIONOVUM Announces Enrollment of First Patient in MAGNIFICENT Trial

MAGNIFICENT trial compares Legflow drug-coated balloon with conventional treatment in the superficial femoral artery or popliteal segment

BONN, March 30, 2016 -- 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 today 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.

About CARDIONOVUM
Based in Bonn, Germany, CARDIONOVUM is focused on developments of truly innovative peripheral and cardiovascular medical devices: specifically, next-generation drug-coated balloon (DCB) and stent technologies, to improve the quality of life of patients. Founded in 2010 by CEO and CTO, Dr Michael Orlowski, CARDIONOVUM has marketing activities in more than 40 countries worldwide. Dr Orlowski is the pioneer of DCB catheters and was the first to obtain CE-marking approval for a DCB, which was introduced into the cardiovascular market in 2007. CARDIONOVUM is commercializing its breakthrough and proprietary drug-transfer platform technology SAFEPAX, which is incorporated into the LEGFLOW peripheral DCB, the RESTORE coronary DCB, and now the APERTO DCB which has been developed and CE-marked exclusively for the treatment of AV fistulas and shunt graft stenosis.

NOTE: CARDIONOVUM's products are not available for sale in the United States.

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