2025Month7Month14Day,JenaValveThe company officially startsARTISTClinical Trial Marks the World's First Targeting Aortic Regurgitation (AR) Patients compared with transcatheter aortic valve replacement (TAVR) and traditional surgical aortic valve replacement (SAVR) The randomized controlled trial has entered the implementation phase.。The trial aims to evaluate its independently developedTrilogy TAVRSystem in Non-Surgical High-RiskARSafety and effectiveness in patients.

ARTISTThe trial adopts an international multicenter, randomized controlled design and is planned to be conducted globally.25Center Inclusion600Example: Moderate to Severe and AboveARPatient. Subjects will be assigned by1:1Proportional Random Assignment to ReceiveTrilogy TAVROr TraditionalSAVRTreatment, the primary endpoint is set as1Annual all-cause mortality and readmission rate composite index. Notably,，The first subject has been enrolled at Cedars-Sinai Medical Center in Los Angeles (Cedars-Sinai) successfully completed the implantation, marking the research entering the substantive advancement stage.

Aortic valve regurgitation, as a common valvular disease, traditionally relies onSAVR, but about30%Elderly or comorbid patients are denied due to surgical risks.TrilogyThe core innovation of the system lies in its patented positioning anchor technology, which enables precise fixation of the valve in regurgitation lesions — a design breakthrough that surpasses traditional methods.TAVRThe device is mainly aimed at aortic valve stenosis (AS) limitations. Chief researcher of the studyRaj MakkarDr. (Director of the Cedars-Sinai Structural Heart Center) pointed out:"ARTISTThe trial will validate whether minimally invasive interventional therapy can replicate its success in the field of stenosis among reflux patients, which may reshape the treatment paradigm for valvular diseases."

According to industry analysts' predictions, if the trial data meets the standards,JenaValveExpected to2025Obtained by the end of the yearFDATargetingARApproval of Indications. CurrentTAVRThe market is mainly dominated by Edwards Life Sciences (Edwards Lifesciences) ofSapienSeries-Dominant (2024Global Market Share in Year68%), andJenaValveIn2024Year7Month Beloved by Edward12Billion dollars under its command (withEndotronixThe expansion of indications this time will further consolidate its leading position in the market (concurrently with M&A transactions).

JenaValveChief Executive Officer (CEO)John KilcoyneEmphasis:"ARTISTThe trial demonstrates our commitment to driving technological innovation through rigorous evidence-based approaches.TrilogyThe system's third-generation nitinol stent and dual-layer leaflet design are specifically optimized for the hemodynamic characteristics of regurgitation lesions."The approval of this device may promoteTAVRIndications fromASToARExpand, expected to2030Year, GlobalARInterventional Treatment Market Size Will Break Through45Billion USD (CAGR 12.7%）。

For patients who cannot tolerate open-chest surgery due to left ventricular dilation or complications,TAVRCan significantly reduce the risk of perioperative complications. Research data shows that patients receivingTAVRTheARThe average hospital stay for patients is relativelySAVRShorten40%，30Daily Mortality Rate from8.2%Decrease to2.1%。ARTISTThe completion of the trial is expected to provide the highest level of evidence for guideline updates, promotingTAVRFrom"Compassionate Use"Switch to standard treatment.