Source of the article:Heart Future; Editor: Sophia
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Recently,Irish Medtech Startup CroíValve Announcement Completed$16 million (equivalent to 115 million RMB) in Series B financing，Both existing and new investors participated in this round of financing.The proceeds of this round of financing will be used forAdvance the clinical development of its novel treatment method for tricuspid regurgitation., and expand the company team.CroíValve SubsidiaryDuo system is a new type of transcatheterCommon AnastomosisHeart valve,It works in conjunction with the native tricuspid valve to restore valve function., using an anchoring system to keep the right heart and natural valve system unchanged. CroíValveDUO™ Tricuspid Fusion Valve SystemIs a novel approach, itCombining Repair and Replacement, providing the right solution for the right heart.The system has received FDA Investigational Device Exemption and is undergoing early feasibility studies.。In February this year,Edward's Evoque ValveBecoming the first transcatheter therapy to receive FDA approval for the treatment of tricuspid regurgitation. In June,Abbott's TriClip Transcatheter Edge-to-Edge Repair (TEER) SystemReceived FDA approval in the United States, becoming the second transcatheter therapy approved for treating tricuspid regurgitation.Edward's device is designed to replace the native valve, while Abbott's device is designed to repair the native valve.，The Duo tricuspid fusion valve system being developed by CroíValve combines the advantages of both.。After the completion of this round of financing, Daniel Gottlieb, a director of Broadview Ventures, joined the board of CroíValve. Ehsan Jabbarzadeh, a venture partner at IAG, joined the board as an observer.The current investors include Ascentifi, Furthr, Broadview Ventures,Atlantic Bridge University Fund, Enterprise Ireland, Elkstone, and SOSV, as well as the newly joined investor IAG Capital Partners.CroíValve CEO Lucy O'Keeffe"This financing proves thatThe Need for Treating Tricuspid Regurgitation Remains Unmet，AndThe Potential of the Duo System to Treat More Patients"We are delighted to introduce this technology to the United States and receive strong support from our group of shareholders, enabling us to fulfill our mission of transforming the lives of patients with tricuspid regurgitation."
Duo Tricuspid Valve Repair System Developed by CroíValve
# Duo Tricuspid Valve Fusion SystemThe Duo system consists of three parts: the stent, the connector, and the valve, and is designed toHelp expand the tricuspid valve leaflet coaptation, through the stentAnchor the product within the superior vena cava., at the same timePosition the valve between the native leaflets., to reduce the size of the regurgitation orifice and provide a contact surface for leaflet coaptation.In addition to the space design, the Duo system also features a tri-leaflet valve structure to support forward blood flow through the tricuspid valve during diastole.Perhaps the risk of device thrombosis can be reduced.。
This new placement and fixation method simplifies the surgical procedure, offers higher safety, and allows for removal post-operation. The implantation process is straightforward, utilizing standard imaging techniques.Unaffected by annulus diameter, valve coaptation gap, leaflet morphology, and visibility., suitable for a wide range of patient populations.
# Latest Research Results
In June 2024, Professor Wojciech Wojakowski presented CroíValve at the New York Valve 2024 Scientific Meeting.Positive 6-Month Results from the TANDEM I First-in-Human Clinical Trial of the DUO™ System for Percutaneous Treatment of Tricuspid Regurgitation (TR)。
TANDEM I Trial is a prospective, non-randomized, multi-center study designed to evaluate the safety and efficacy of the DUO System in patients with severe TR symptoms. The study reports on 10 enrolled patients, demonstrating sustained positive outcomes.- Treatment significantly reduces tricuspid regurgitation (TR) in patients.Exceed85%The TR level of the patient was reduced to moderate or lower.；
- The patient's function and quality of life alsoSignificant Improvement, Kansas City Cardiomyopathy Questionnaire (KCCQ) scores and 6-minute walk test (6MWT) both showed significant increases from baseline;
- The survival rate of patients at 6 months post-operation is100%；
- No arrhythmias or conduction disorders requiring permanent pacing occurred, demonstrating the advantages of avoiding right heart contact.
- Data also shows devicesLong-term stable positioning and function, while also supporting natural reverse remodeling;
- Even in the case of first-time use,The average implantation time for the device is only43 minutes`, Simplified the surgical experience`。
TANDEM I Trial ShowsIn all key indicators, the patient's symptoms have shown significant improvement.。Wojakowski said: "The six-month results of the Duo system are very promising, not only because of its clinical safety and effectiveness, but also because of the simplicity of the procedure and the broad applicability of the technology."This system offers new hope for patients with severe TR, providing a versatile and predictable treatment option that simplifies the surgical and imaging experience for doctors."In January 2024, after receiving FDA Investigational Device (IDE) approval, CroíValve began itsEarly Feasibility Study of the Duo System。Tandem II is a prospective, multi-center, non-randomized, single-arm study designed toObservation of the Safety and Efficacy of Duo in Patients with Severe or More Severe Tricuspid Regurgitation (TR)。
CroíValve, founded in 2016, is a clinical-stage medical device company.Focused on developing a novel transcatheter device for the treatment of tricuspid regurgitation. Company ResearchDevelopment and operations are based in Ireland, while clinical and regulatory activities are located in the United States. The founding team has extensive experience in clinical, technical, and commercial fields.
Editor-in-Chief | Zhao Qing Reviewed by | Yi He
