On May 12th, 2023, Dr. Michael Lee and his team from the Cardiology Department of Queen Elizabeth Hospital in Hong Kong successfully completed two Trilogy Heart Valve System implants for inoperable severe aortic regurgitation patients. This is the first Asian commercial implantation of Trilogy, which marks the official launch of Trilogy in Hong Kong. That technique provides a safe and efficient minimally invasive transfemoral interventional treatment option to more patients with symptomatic severe aortic regurgitation (AR) in the future.
These two patients were diagnosed with inoperable, symptomatic severe aortic regurgitation. Dr. Michael Lee and his team, Dr. Ivan Wong, Dr. Angus Chui detailed assessed the patient's condition and anatomical structures and elaborated the procedural strategy and simulation before the transcatheter aortic valve implantation (TAVI) procedure. They successfully completed the two cases under local anesthesia, with the average device time at 25 minutes (from sheath-in to sheath-out). The acute procedural results were ideal by good valve positioning, none to mild aortic regurgitation, and significantly improved hemodynamics.
【Challenges of AR Transfemoral TAVI solution】
《2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease》states that TAVI for isolated chronic AR is challenging because of dilation of the aortic annulus and aortic root and, in many patients, lack of sufficient leaflet calcification. Risks of TAVI for treatment of AR include transcatheter valve migration and significant paravalvular leak. TAVI is rarely feasible, and then only in carefully selected patients with severe AR and HF who have a prohibitive surgical risk and in whom valvular calcification and annular size are appropriate for a transcatheter approach.
The off-label clinical use of TAVI devices designed for aortic valve stenosis have limited application in AR patients, due to highly careful selection of patient anatomy and experienced operators and the heart team. Designing a dedicated transfemoral TAVI device for AR with higher success rate, lower complications, and shorter learning curve has become an urgent unmet clinical needs.
【JenaValve Trilogy Meets the Unmet Needs Particularly in the Field of Transfemoral Aortic Valve implantation for Aortic Regurgitation】
Upon the commitment of delivering breakthrough innovation in the treatment of TAVI for AR, JenaValve Trilogy Heart Valve System obtained CE Mark approval in 2021, which is the first transfemoral TAVI system in the world indicatded for both aortic regurgitation and aortic stenosis[1]. As of today, this is the only transfemoral TAVI system for the treatment of AR approved by CE Mark.
Its unique locators design can clip the native valve leaflets, reducing the surgical risk of valve displacement and complications such as valve-in-valve. Its unique valve frame design enables effective anchoring and sealing, and the large cell and the commissural alignment contributes to easy coronary re-access.
The real world data in Europe showed that[2], the technical success in the Trilogy AR group was 100%, and the 30-day follow-up results showed that all patients had mild or no paravalvular leakage. At present, over a hundred Trilogy cases have taken place in multiple European centers, and the ALIGN-AR pivotal trial has been successfully completed patient enrollment. It is expected to become the first FDA-approved transcatheter aortic valve interventional treatment device indicated for severe aortic regurgitation.
【Peijia Medical’s Important Step to Bring First-in-Class Aortic Valve Regurgitation System with Multiple Initiatives】
At the beginning of 2022, Peijia Medical (9996.HK) entered into a collaboration and license agreement with JenaValve. In mainland China, Peijia Medical will leverage our advantanges of operation management and will accelerate the registration of the local manufactured valve system using the license-in technology. In addition, collaborating with the distribution of Peijia Medical, JenaValve commercialize Trilogy in Hong Kong. JenaValve and Peijia Medical will be committed to benefiting patients in Greater China by expanding indications to AR with clinically proven minimally invasive option.
Dr. Michael Lee, Head of Cardiology, Consultant Cardiologist, Queen Elizabeth Hospital, Hong Kong SAR, China
The Trilogy Heart Valve System is a highly innovative therapeutical option licensed for both severe AR and severe AS patients. We are inspired that the Trilogy procedure is quite predictable due to its solid anchoring and the locator technology limiting the displacement, and the results of the first two cases of inoperable AR were successful and satisfying. These two AR cases are the first implantation with on-label TAVI transfemoral system in Asia. We do hope that Trilogy technique could save more patients who are suffering severe AR related disease in the future.
Dr. Zhang Yi，Peijia Medical President and CEO
This cooperation with JenaValve is an important milestone for Peijia Medical to expand its commercialization market. Peijia Medical is committed to serving more clinical centers through cutting-edge unique innovative technologies, so that more innovative treatment options could benefit more patients. With the vision of “dedication with passion, devotion to life”. From an international perspective, Peijia Medical will keep creating a local medical innovation ecology and promote the further implementation of innovative devices and revolutionary therapies in the field of structural heart worldwide.
John Kilcoyne, JenaValve CEO
We are clearly thrilled about the first commercial implants of the Trilogy Heart Valve System in Hong Kong SAR, China. This marked a major milestone accomplishment for the clinical use of Trilogy in Asia. We look forward to partnering with Peijia Medical and opinion leaders of Greater China to treat more severe, symptomatic aortic regurgitation patients in future.
Peter Spadaro, JenaValve CCO
The Trilogy Heart Valve offers a new option and more importantly an effective solution for symptomatic, severe AR patients who historically had very few options for treatment. We are greatly encouraged by the first implants in Hong Kong and will be devoted to the future promotion of Trilogy in Asia. We are happy to see that the cooperation between Jenavalva and Peijia could provide operators with cutting-edge technology, which is aimed at improving the lives of our patients at the top speed.
【Reference】
[1] JenaValve Technology Receives CE Mark for its Trilogy™ TAVI System for the Treatment of Aortic Regurgitation and Aortic Stenosis. IRVINE, Calif., May 25th, 2021. https://jenavalve.com/jenavalve-receives-ce-mark/.
[2] The Dedicated Jenavalve Trilogy TAVR System for Aortic Regurgitation: Early EU Experiences. Alexander R. Tamm. University Medical Center Mainz, Germany. TCT 2022.
Indication Statement: “The Jenavalve Trilogy Heart Valve System (transfemoral) is indicated for use in patients with symptomatic severe aortic regurgitation (AR) or symptomatic severe aortic stenosis (AS) who are judged by a Heart Team (including a cardiac surgeon), to be at high or greater risk for surgical aortic valve replacement.
CAUTION-Investigational Device. Limited by Federal (or United States) law to investigational use
