CARDIONOVUM Announces Enrollment Completion of RAPID 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, today announced the completion of enrollment of the RAPID trial. Results will be used to further support the safety and effectiveness of CARDIONOVUM’s Legflow® drug-coated balloon (DCB).
The RAPID study is a multi-center, randomized, controlled, patient-blinded clinical trial comparing the Legflow® drug-coated balloon (DCB) and stenting to conventional percutaneous transluminal angioplasty (PTA) and stenting in 160 “real-world” patients with highly challenging intermediate and long lesions in the superficial femoral artery (SFA). Patients were pre-dilated according to randomization, and all patients were then treated with the Supera® peripheral stent system (Abbott Vascular). The primary endpoint is the absence of binary restenosis of the treated SFA segment at two years.
Preliminary adjudicated results for a subset of patients at 1 year presented at LINC 2016 showed very promising results in the Legflow group. These results are expected to be published in July.
Principal Investigator, Dr J.-P. de Vries from the St Antonius hospital in Nieuwegein, The Netherlands, said, “We look forward to seeing the final results of the RAPID trial which we expect will confirm the promising results we have seen so far. These results are expected to validate the Legflow DCB as an effective solution for the treatment of challenging SFA lesions. We thank all the study collaborators for their support in recruiting patients.”
The study design for RAPID has been published in Trials 2013 14:87; DOI: 10.1186/1745-6215-14-87.
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. More than 22,000 patients worldwide have been treated with the Legflow DCB.
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.
Stefan B. Beerhalter
VP Global Sales & Marketing
+49 228 90 90 590