CARDIONOVUM® announces the first Signature Randomized Clinical Trial patient enrolment

Bonn, Germany. CARDIONOVUM® announced today the first Signature Randomized Clinical Trial patient enrolment.

On June 8th, in Sankt Gertrauden hospital in Berlin, Germany, the first Signature RCT patient has been enrolled. Dr. Ralf Langhoff, P.I. of the study, stated “I believe that this randomized study will confirm, once more, the efficacy and the safety of the Legflow® DCB in the daily treatment of the SFA and popliteal lesions.”

Signature, is a non-inferiority randomized trial intents to compare the performance of LEGFLOW® drug coating balloon versus simple plein balloon.

LEGFLOW® is characterized by a 3rd generation amorphous paclitaxel coating, which provides 100% drug delivery to the target lesion and avoids the particles drug loss into the blood stream.

The international randomized multicentre Signature trial will enrol 148 patients in centres across Germany, Switzerland and Brazil.

Signature’s primary endpoints are:

• Efficacy: Target Lesion Revascularization (TLR) at 12 months.
• Safety: Freedom from device- and procedure-related death through 30 days and a composite of major target limb amputation and CD-TVR @ 12 months.

Miquel Craven-Bartle Capella CEO of Cardionovum® commented: “We are very happy with this first enrollment. As Cardionovum® we are fully convinced that our LEGFLOW® DCB, with its unique coating Safepax® technology, will deliver to the patients the best results for the treatment of the peripheral arteries diseases.”

ABOUT CARDIONOVUM® GMBH

CARDIONOVUM® GmbH is a medical technology company based in Bonn, Germany, that develops and commercializes innovative medical devices such as the new generation of drug coated balloons and drug eluting stents for the treatment of coronary and peripheral artery disease. The company’s pioneering range of DCBs is based on the SAFEPAX® paclitaxel coating matrix which has the lowest wash-off rates on the market. The company’s clinical program ensures the continuous growth of the clinical evidence that supports the benefits of our products.