Cardionovum® is proud to announce a major milestone: For the approval by ANVISA, the Brazilian Health Regulatory Agency, of Aperto® OTW DCB for commercial use in Brazil. This approval enables Brazilian patients undergoing dialysis to benefit from a therapy that extends the lifespan of their arteriovenous fistulas, thereby improving both quality of life and treatment outcomes.
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.”
At EuroPCR 2025, Dr. Aloke Finn and Prof. Antonio Colombo discussed the under-recognized issue of particulate embolization after drug-coated balloon (DCB) angioplasty.
They clarified its distinction from traditional distal embolization and underscored its iatrogenic nature—originating from the device, not plaque or thrombus. The conversation highlighted that particle size, carrier type, and coating technology, particularly crystalline-like coatings, play key roles in downstream safety.
While not universally problematic, embolization may be relevant for specific patients or devices. They stressed the need to translate preclinical insights into clinical practice and to innovate DCB technologies that balance safety with efficacy.
Prof. Matteo Tozzi (Varese, Italy) spoke to Vascular News about his extensive experience with drug-coated balloons (DCBs) in vascular access, particularly the Aperto® OTW DCB by Cardionovum®.
Having used over 600 DCBs in the past decade, Tozzi emphasized the superior efficacy of Aperto® OTW compared to plain balloon angioplasty (POBA).
To address the lack of economic data, he has initiated an analysis to evaluate the cost-effectiveness of DCBs in treating vascular access failure: based on the findings of his study named Aperto 600, Tozzi advocates for DCBs to be considered a “first-line treatment” for stenosis and vascular access failure in haemodialysis patients.
Dr. Testa (Milan, Italy) discusses the results of the XLIMIT Trial with Radcliffe at the EuroPCR 2024 congress in Paris, France.
In this video interview, Dr. Testa explains the technology behind the XLIMUS® drug-eluting stent (Cardionovum®) and its benefits. He also reviews the XLIMIT Trial, detailing the study design, selection criteria, and clinical outcomes.
Specifically, the 6 to 9 months follow-up results showed that the XLIMUS® DES was comparable to the Synergy™ DES on both primary endpoints (in-stent neointimal percent volume obstruction and in-stent neointimal volume). No difference was also found with respect to the secondary OCT endpoints as well as for clinical endpoints.
The study results confirm that the biological interaction of the XLIMUS® and Synergy™ DES with the coronary artery is comparable, and that translates in very reassuring OCT parameters at follow-up: as such, the XLIMUS® DES is non-inferior to the Synergy™ DES.
Cardionovum invites you to participate in on demand interviwes:
XLIMIT Trial RCT, with Dr. Luca Testa from Italy. Goal: to assess angiographic and clinical performance of the Xlimus Biodegradable Polymer Sirolumus-eluting stent versus a gold standard like Synergy Biodegradable Polymer Everolimus Stent in patients treated with percutaneous coronary angioplasty.
Hyper Registry with Dr. Alfonso Ileasi from Italy. Goal: Asses the clinical results after a Hybrid Approach in diffuse CAD lesions longer tan 28mm combinig Restore DCB and New generation DES.
