News and Events - Cardionovum®

Latest press release

Oct 03, 2023

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).

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

Oct 03, 2023

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]).

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

July 10, 2023

Dott. Ielasi discusses about the results of the 2 years clinical outcomes of the HYPER Study and the benefits of RESTORE® DEB

Dott. Ielasi (Milan, Italy) speaks to Radcliffe at EuroPCR 2023 congress held in Paris (France) about the results of the Hyper Study 2-years Follow-up.

In this video interview, Dott. Ielasi summarizes the benefits of RESTORE® paclitaxel eluting balloon and comments the results of the Hyper study at 2 years, putting a focus on the encouraging results of the combined use of modern DES and RESTORE® DEB in the context of de novo diffuse CAD: in detail, results showed a 2-year clinical follow-up available for the vast majority of the patients enrolled (n=105/106, 99%) and a low incidence of Device oriented Composite Endpoint (DoCE) equal to 4.6% at 24 months.

In conclusion, even if larger and more robust data from RCTs (vs. full metal jacket PCIs) are needed to confirm the findings, the HYPER study reports very encouraging results in terms of safety and efficacy of the hybrid approach in the treatment of diffuse CAD.

Learn more >> Dott. Ielasi discusses about the results of the 2 years clinical outcomes of the HYPER Study and the benefits of RESTORE® DEB

June 02, 2023

Prof. Tozzi discusses about Aperto® drug-coated balloon as a “first-line” treatment of neointimal hyperplasia in ArterioVenous Fistula (AVF) lesions and CVS

Prof. Matteo Tozzi (Varese, Italy) spoke to Vascular News at Charing Cross 2023 meeting held in London (England) about the variety of vascular access complications and their treatment options.

In this video-interview, Prof. Tozzi commented as fantastic the clinical outcomes of Aperto® DCB in his recent analysis, in which more than 600 Aperto® DCB have been used in ArteriousVenous Fistula (AVF) and AVG, including a large number of Central Vein Stenosis (CVS).

Learn more >> Prof. Tozzi discusses about Aperto® drug-coated balloon as a “first-line” treatment of neointimal hyperplasia in ArterioVenous Fistula (AVF) lesions and CVS

Dec 05, 2022

Dr. Lichtenberg discusses about Aperto® drug-coated balloon technology and its promising results in dialysis access patients

Prof. Michael Lichtenberg (Arnsberg, Germany) speaks to Vascular News at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2022 annual meeting in Barcelona (Spain) about the importance on new endovascular strategies, such as Drug-Coated Balloons (DCBs), to improve patency rates in patients with consecutive neointimal hyperplasia in haemodialysis access.

In this interview, a particular focus is put on the promising results of APERTO^®OTW, our high-pressure paclitaxel releasing DCB, considered as “one of the very promising new technologies” for treating restenosis in dialysis access patients

Learn more >> Dr. Lichtenberg discusses about Aperto® drug-coated balloon technology and its promising results in dialysis access patients

Nov 16, 2022

Late-Breaking Xlimit RCT data presented at CSC Congress demonstrate an equivalent performance of the Xlimus® DES in terms of OCT derived endpoints than the Synergy™ DES.

Bonn, Germany. November 16, 2022 – Data presented at Innovation session today at the CSC 2022 congress demonstrated an equivalent performance of the Xlimus® DES in terms of OCT derived endpoints than the Synergy™ DES, including Neointimal Volume and Neointimal Volume weighted by length at 6 months. Secondary endpoints, including other OCT parameters, such as in-stent Minimum Lumen Area (MLA) and percentage of strut coverage as well as clinical endpoints, showed no significant differences between the two groups in any of the evaluated parameters within the Xlimit RCT.

Learn more >> Late-Breaking Xlimit RCT data presented at CSC Congress demonstrate an equivalent performance of the Xlimus® DES in terms of OCT derived endpoints than the Synergy™ DES.