Cardionovum® Announces Publication of “APERTO 600” Study Demonstrating Long-Term Efficacy of Aperto® OTW High Pressure DCB in Vascular Access Management

Cardionovum® is proud to announce that the“APERTO 600” study, evaluating the efficacy of the Aperto® OTW DCB in vascular access occlusion management, has been published in the Journal of Vascular Access under the title: “Real-World Outcomes of 600 Drug-Coated Balloon Angioplasties.”

APERTO 600 is a single-center, retrospective cohort study analyzing 600 drug-coated balloon (DCB) angioplasties performed in patients with stenoses or thromboses in arteriovenous fistulas (AVFs), vascular access grafts (AVGs), and central veins (CVS).

The study confirmed the excellent performance of Aperto® OTW DCB, reporting overall functional patency rates of 80%, 63%, and 47% at 12, 24, and 36 months, respectively. Freedom from restenosis at 12 months was71% for AVFs, 64% for AVGs, and 57% for central vein stenoses. Notably, the annual re-intervention rate was 1.3 (IQR: 0.9–3.1), with no major adverse events or vascular injuries reported.

Professor Matteo Tozzi, Principal Investigator of the study, stated:
"Aperto® OTW DCB is a safe and effective treatment for vascular access stenoses, demonstrating robust functional patency and low restenosis rates. Our findings support its use as a cornerstone in vascular access management, highlighting its role in reducing complications and maintaining long-term access functionality."

ABOUT CARDIONOVUM®

CARDIONOVUM® is a German medical device manufacturer specializing in the development and commercialization of innovative cardiovascular and peripheral artery therapies, including next-generation drug-coated balloons and drug-eluting stents. The company’s mission is to translate scientific innovation into clinically breakthrough medical devices that improve patient outcomes and quality of life.