CroíValveReversible Tricuspid Valve Repair Technology Announced at New York Valves 2024 ConferenceDUOTheFor the first timeClinical Research in Humans (TANDEM I) The data shows good results.TANDEM I Trial is a prospective, non-randomized, multi-center study designed to evaluate the safety and performance of the CroíValve DUO in patients with severe symptomatic TR. Data from 10 patients in this volunteer cohort.Specific Research Data
- Results at six months showed a significant reduction in TR among treated patients, with over 85% experiencing a reduction to moderate or lower.
- Patients' function and quality of life also significantly improved, with KCCQ scores and 6MWT both showing significant increases from baseline.
- The survival rate of patients at 6 months post-operation was 100%;
- The reported incidence of arrhythmias or conduction disorders that do not require permanent pacing demonstrates the advantages of avoiding right-heart contact.
- The data also demonstrate the long-term stable positioning and functionality of the device, while supporting natural reverse remodeling.
- Even in the case of first-time use, the average implantation time for the device was only 43 minutes.
PI Evaluation
"The results of DUO at six months post-operation are very promising, not only because of its clinical safety and effectiveness, but also due to the simplicity of the surgical procedure and the broad applicability of the technology."DUO"Brings new hope to patients with severe TR, providing a versatile and predictable treatment option that simplifies the operator's surgical and imaging experience."
---Wojtek Wojakowski Medical University of Silesia"These data are encouraging and demonstrate the success of DUO in reducing TR and improving patients' quality of life. Our goal is to expand treatment options for patients with tricuspid valve disease. We are committed to building strong evidence to support emerging therapies like DUO and are conducting further clinical research and patient follow-ups."---Martin Quinn, Chief Marketing Officer of CroíValve
DUO
DUOComposed of three parts: stent, connector, and valve.
DUOAimed to help the coaptation of the expanded tricuspid valve leaflets through a stent.DUOAnchored within the superior vena cava while positioning the valve between the native leaflets to reduce the size of the regurgitant orifice and provide a contact surface for leaflet coaptation. In addition to the simple space-occupying design,DUOIt also has a tri-leaflet valve structure to support forward blood flow through the tricuspid valve during diastole, which may potentially reduce the risk of device thrombosis.DUOThis new placement and fixation methodAchieved simplification of the surgery.DUODue to the adoption ofSetThis new fixation method, as opposed to the traditional tissue-penetrating anchoring approach, allowsDUOHigher safety, allowingDUOIt is very important to remove it after the operation.（Biological ValveShort membrane life directly leads to patients being unable to use it before the end of the year, which is a headache problem).
CroiValveCroíValve is an early-stage medical device company focused on developing minimally invasive devices for the treatment of tricuspid regurgitation. Headquartered in Dublin, Ireland, the founding team possesses extensive clinical, technical, and commercial expertise.
