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The HYPER Study Findings: Hybrid Approach with Restore® DEB Shows Promising Long-Term Results

Dott. Ielasi (Milan, Italy) speaks to Radcliffe at EuroPCR 2024 congress held in Paris (France) about the results of the Hyper Study 2-years Follow-up.

 

In this video interview, Dr. Ielasi explains the technology behind the Restore® drug-coated balloon (Cardionovum®) and its advantages. Furthermore, he offers a comprehensive analysis of the HYPER Study, elucidating its methodology, participant selection criteria, and clinical outcomes.

 

Specifically, the 1-year outcomes revealed that DoCE was 3.7%. Subsequently, an extensive 2-year follow-up demonstrated a DoCE rate of 4.6%, maintaining stability up to the 3-year analysis.

 

In conclusion, the HYPER Study demonstrated that the hybrid approach combining a drug eluting stent with the Restore® DEB is not only feasible but also associated with very high procedural success and a remarkably low 1-year DoCE rate. These favourable results remain consistent over the 3-year follow-up period.

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Dr. Lichtenberg discusses about Aperto® DCB in the Archives of Internal Medicine Research journal

Cardionovum® is present in the Archives of Internal Medicine Research (ISSN: 2688-5654) in the article entitled “Drug Coated Balloon Angioplasty for Dysfunctional Arteriovenous Fistula: A New Standard-of-Care in the Horizon?”.

 

In this recent article, Dr. Lichtenberg unveils the role of DCBs in Vascular Access Management, and an entire chapter is devoted to our Aperto® OTW drug coated balloon with an extensive overview of its main technical features and clinical results.

 

The Archives of Internal Medicine Research (ISSN: 2688-5654) is an open access peer-reviewed journal providing innovative and clinically relevant research platform for physicians, practitioners, pathologists, pharmacologist and students in general internal medicine and internal medicine subspecialties with an Impact Factor 3.6.

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Cardionovum® Recognized Among Europe's Top 10 Cardiovascular Solutions Companies in 2023

We are glad to announce Cardionovum®'s prestigious recognition as one of the Top 10 Cardiovascular Solutions Companies in Europe for 2023 by MedTech Outlook.

 

This acknowledgment reflects our unwavering commitment to innovation and excellence within the field of cardiovascular solutions.

Being included in this list is a proof to our Team's dedication and the impact of our pioneering technologies.

 

In addition, we are honored to be present in the November edition of MedTech Outlook magazine, providing an in-depth article that delves into our contributions in driving innovation to improve patients' lives.

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Cardionovum® Takes the Spotlight in Vascular News journal: Prof. Tozzi's Insights about Aperto 600 Study

Cardionovum® is present in the Vascular News’s November edition with an article in which Prof. Tozzi (Varese, Italy) shares the clinical outcomes of the Aperto 600 Study, in which more than 600 Aperto® DCBs have been used in ArteriousVenous Fistula (AVF) and ArteriousVenous Graft (AVG), including a large number of Central Vein Stenosis (CVS).

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XLIMUS® DES: XLIMIT Trial results published on Frontiers in Cardiovascular Medicine journal

Cardionovum® announces that the XLIMIT Trial results, featuring the XLIMUS® DES, have been published online in the Frontiers in Cardiovascular Medicine journal with the article entitled “A randomized control trial to assess optical coherence tomography parameters of the Xlimus drug-eluting stent: the XLIMIT trial”.

 

XLIMIT is a non-inferiority, prospective, multicenter, randomized, controlled trial in which a total of 177 patients were enrolled and randomized in two groups in a 2:1 ratio (2 XLIMUS®:1 Synergy™).

The primary endpoint of this study has been defined as the in-stent neointimal volume weighted by the sum of the lengths of implanted stent (ISNV), and the in-stent percent neointimal volume obstruction (%VO) were evaluated at 6-9 months by means of Optical Coherence Tomography (OCT).

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RESTORE® HYPER study results published on Minerva Cardiology and Angiology journal

Cardionovum® announces that the HYPER Study results, featuring the innovative RESTORE®  DEB, have been published online in the Minerva Cardiology and Angiology journal, with the article entitled "Procedural and one-year outcomes following drug-eluting stent and drug-coated balloon combination for the treatment of de novo diffuse coronary artery disease: the HYPER Study”.

 

The HYPER is a prospective, multicenter study including patients affected by de novo diffuse CAD treated with a hybrid approach from April 2019 to December 2020, having as primary endpoint the evaluation of the 1-year device-oriented composite endpoint (DoCE, cardiac death, target vessel myocardial infarction and ischemia-driven target lesion revascularization [ID-TLR]).

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Latest events

Cardionovum® at CSC 2022

Cardionovum® is delighted to announce the release of the XLIMIT Randomized Clinical Trial data.

  • Dr. Luca Testa, the PI of the study, will share his findings on the topic of:
    “    OCT-based analysis of XLIMUS® DES vs. SYNERGY DES”

    Thursday 16th November at 17:45h
    SALA MADRID 1-2

Location:

Hotel Riu Plaza España
Calle Gran Vía, 84,
28013, Madrid, Spain

You are welcome to visit us at booth #2

Date: Nov 16, 2022–Nov 17, 2022

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Cardionovum at GISE 2022

Cardionovum invites you to attend a scientific session:

  • GAP IN KNOWLEDGE:
    Role of drug-coated balloons in de novo lesions

    Dr Alfonso Ielasi - the PI of the Hyper study - will share his findings on the topic of:
    Clinical scenario: “A patient treated with a hybrid DES-DEB strategy”

    Thursday 11st October at 14:30h
    ROOM AMBER 5-6

Location:

Allianz MiCo - Milano Congressi
South Wing
Viale Eginardo - Gate 2
20149 Milano, Italy

You are welcome to visit us at booth #45, 2nd Floor (ALA SUD)

Date: Oct 11, 2022–Oct 15, 2022

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Cardionovum at CIRSE 2022

Cardionovum invites you to visit us at booth #70

Location:

CCIB Conference Center
Plaça de Willy Brandt, 11-14,
08019 Barcelona, Spain
 

Date: Sep 10, 2022–Sep 15, 2022

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