Cardionovum

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Cardionovum® Announces ANVISA Approval of Aperto® OTW DCB for Brazilian Market

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.

 

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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.”

 

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EuroPCR 2025 Roundtable: Particulate Embolization in DCB Angioplasty

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.

 

 

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A Decade of Innovation: Matteo Tozzi's Insights on Drug-Coated Balloons in Vascular Surgery

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.

 

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“Aperto® DCB: A Glimpse of the Future Today” Webinar

If you were unable to attend the webinar "Aperto® DCB: A Glimpse of the Future Today,” you can still view the session.

 

Please click here to access the video.

 

Thanks to Dr. Kitrou from Patras, Prof. Tozzi from Varese, and Dr. Shahverdyan from Hamburg, you will have the opportunity to:

 

  • Gain a comprehensive overview of the DCB’s role in the Vascular Access landscape today and in the future;
  • Receive the latest clinical update on Aperto® and its cost-benefit implications;
  • Participate in a practical session with a discussion on challenging cases.

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The XLIMIT Trial: XLIMUS® DES Shows Non-Inferiority to Synergy™ DES

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.

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Upcoming events

Currently there are no events.

Latest events

Cardionovum at Linc 2022

Cardionovum invites you to participate in a scientific session:

  • Pr. Matteo Tozzi will disclose the results of his study:
    Paclitaxel blood concentration after peripheral DCB PTA evaluated by HPLC

    Tuesday 7th June at 14,25h
    Speakers Corner

     

You are welcome to visit us at booth #10

Date: June 06, 2022–June 10, 2022

Location: Trade Fair Leipzig, Hall 2 - Seehausener Allee 1 - 04356 Leipzig, Germany

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Cardionovum at EuroPCR 2022

Cardionovum invites you to participate in 3 scientific sessions:

  • XLIMT trial with Dr. Luca Testa.
    Primary end point presentation.

    Available online:
    Poster Lab section
    17th-20th May

  • Restore SVD randomized trial with Dr. Changdong Guan.
    4 Year follow up presentation.

    On demand section:
    17th-20th May

  • HYPER study with Dr. Alfonso Ielasi.
    Primary end point presentation.

    In person presentation:
    Thursday 19th, 10:30- 12:00h Room Maillot

You are welcome to visit us at booth F6

Date: May 17, 2022–May 21, 2022

Location: France Palais des congrès, Paris

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Cardionovum GmbH at: "A glimpse into the future"

Cardionovum GmbH participates in:
The 1st symposium of interventional & clinical cardiology "A glimpse into the future". Dominican Society of Cardiology.

You are cordially invited to visit our booth.

Location: Convention Center, UTESA, Santiago, Dominican Republic

Download the program here (PDF)

Date: Jan 28, 2022–Jan 30, 2022

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