CARDIONOVUM® announces First Procedure in Hyper II International Clinical Trial.

Bonn, Germany. CARDIONOVUM® today announced the enrollment of the first patient in the International Hyper II Clinical Study designed to evaluate the safety and efficacy at 12 months of the hybrid treatment approach combining RESTORE® paclitaxel-coated balloon with new generation drug eluting stent in long diffuse CAD.

The first procedure of the Hyper II Clinical Study was performed on July 27 at Sant’Ambrogio Cardio-Thoracic Center in Milan, Italy by Dr. Alfonso Ielasi, M.D., P.I. of the study.

Developed exclusively at Cardionovum, Restore® paclitaxel-coated balloon utilizes a unique combination of rapid absorption drug – paclitaxel – and patented SAFEPAX® paclitaxel coating matrix which has the lowest wash-off rates on the market.

The Hyper II is a prospective, non-randomized, multi-center clinical trial that will enroll up to 500 patients across 15 international sites and is built upon the findings of the Hyper Study presented at the EuroPCR 2022, showing encouraging clinical results in terms of Device oriented Composite Endpoint (DoCE) of 3.7% at 12 months with no thrombosis reported in DES and DCB treated segments¹. The primary endpoint of Hyper II study has been defined as the Target lesion failure (TLF) incidence and will be assessed within 12 months after the index procedure.

“De novo diffuse coronary artery disease still represents an open issue in the field of interventional cardiology. Overlapping DES and DCB in order to limit the total stent length may reduce the risks associated with permanent rigid metallic cages within the coronary wall.
This concept could be particularly important in case of very long lesions involving small vessels and in diabetic patients.” said Alfonso Ielasi, M.D., lead principal investigator of the Hyper and Hyper II Studies.

Miquel Craven-Bartle Capella CEO of Cardionovum® commented: “Following our claim “Life deserves the best”, we are committed to improving patients’ quality of life by providing innovative solutions and clinical evidence for the treatment of cardiovascular disease. We are excited to announce the first procedure in the Hyper II trial and we truly hope that this trial will help generating a larger body of clinical evidence for a better treatment of patients with diffuse coronary artery disease."

¹ A.Ielasi. EuroPcr 2022

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.