London, UK - November 19th - November 21st, 2023, evidence-based data from the VitaFlow^® Transcatheter Aortic Valve (VitaFlow^®), developed by MicroPort^® CardioFlow (hereinafter referred to as MicroPort^® CardioFlow, stock code: 02160.HK), were revealed on PCR London Valves, a leading global event on structural heart diseases. The data showed that the long-term and excellent clinical outcomes of VitaFlow^® have reached the international mainstream level, and this is also the first time for the domestically-developed transcatheter aortic valve system to publish 7-year long-term follow-up data in the international authoritative academic arena in the field of interventional treatment of heart valve disease.

During this period, VitaFlow Liberty^® Transcatheter Aortic Valve and Retrievable Delivery System (hereinafter referred to as VitaFlow Liberty^®) and VitaFlow^® Ⅲ Retrievable Steerable Delivery System (hereinafter referred to as " VitaFlow^® Ⅲ"), which are the second and third generation of TAVI products of MicroPort^® CardioFlow, were also presented at PCR London Valves 2023. This sparked significant interest and garnered high praise from interventional practitioners worldwide!

Integrating Theory and Practice, The High-quality evidence-based publication and product series of VitaFlow^® display

Several internationally renowned academic experts in the field of cardiovascular intervention, including Prof. Darren Mylotte from Galway University Hospitals, Prof. Xiaochun Zhang from Prof. Daxin Zhou's team at Zhongshan Hospital, Prof. Ole De Backer from The Heart Center, Rigshospitalet, Prof. Angela Mclnerney from Galway University Hospital and Prof. Oscar Mendiz from Favaloro Foundation University Hospital, were invited to participate in PCR London Valves 2023, during which they highly praised the excellent clinical performance of VitaFlow^® series products and the unique design of the world's first motorized retrievable device, and discussed the future development direction of the TAVI field with the help of VitaFlow^® series products in light of their clinical practice experience.

Surgical Patients with High-Risk, Severe Aortic Stenosis 7-Year Follow-Up Results Announced for VitaFlow^® -Prof. Xiaochun Zhang

During the conference, Prof. Xiaochun Zhang, PI of the VITAL trial and member of Prof. Daxin Zhou's team from Zhongshan Hospital, shared with global scholars the excellent long-term results of implanting VitaFlow^® in high-risk, surgical patients with severe aortic stenosis - The data demonstrated a significant reduction in all-cause mortality, cardiac mortality, and permanent pacemaker implantation rates over seven years compared to other similar studies.

Prof. Xiaochun Zhang highlighted that the all-cause mortality rate at 7 years was 31.4%, with low occurrences of structural valve degeneration (SVD) and bioprosthetic valve failure (BVF). The effective orifice area of the valve remained at 1.88 cm², and hemodynamic results were similar for both bicuspid and tricuspid aortic valve patients, providing strong long-term data to support the safety and efficacy of VitaFlow^® .

The VITAL trial is an observational, multicenter, single-arm trial to validate the safety and efficacy of VitaFlow^® in patients with severe symptomatic aortic stenosis who are not candidates for surgical aortic valve replacement (SAVR). A total of 110 patients who completed VitaFlow^® implantation at four structural heart disease centers in China between October 2015 and September 2016 were enrolled in the study, with postoperative follow-up for all-cause mortality of 2-10 years and 6-10 years, and ultrasound follow-up was initiated in order to better study the patients' mid- and long-term valve clinical data. The primary endpoint of the study was all-cause mortality at 12 months, and secondary endpoints were device success, procedural success, major stroke events, valve performance, improvement in cardiac function, MACCE events, and improvement in quality of life.

Regarding baseline data, patients had a mean age of 77.73 years, mean cardiac STS score of 8.84, a high proportion of bicuspid aortic valves (42/110), a left ventricular ejection fraction (LVEF value) of 57.22±12.00%, an effective orifice area of 0.64±0.19 cm², and a mean aortic valve transvalvular pressure difference of 60.41±19.40 mmHg.A total of 83 patients completed 7-year follow-up, with an all-cause mortality rate of 31.4%, a cardiovascular mortality rate of 14.9% (13), an acute infarction incidence rate of 16.1% (14), a major stroke event rate of 4.9% (4), a new pacemaker implantation rate of 24.8% (22), and an aortic valve re-intervention rate of 1.25% (1); 5% (3/60) of patients developed severe aortic valve regurgitation and all of them were central regurgitation; the incidence of BVF was 3.75% and the incidence of moderate/severe SVD was 8.11%, which were lower than the results of other long-term studies (8-year follow-up results of the NOTION trial and 5-year follow-up results of the PARTNER 2 trial). In terms of hemodynamic outcomes, patients had an effective orifice area of 1.88 cm² and a mean transvalvular pressure difference of 7.82 mmHg at 7 years, while patients with bicuspid versus tricuspid aortic valves did not have a significant difference in effective orifice area (BAV 1.79 cm²,TAV 1.96 cm², P=0.2378) or mean transvalvular pressure difference (BAV 8.41 mmHg vs. TAV 7.38 mmHg, P =0.4434) were not significantly different.

Prof. Ole De Backer:

"The seven-year follow-up data from the VITAL trial are impressive. In contrast to the NOTION study, the PARTNER 3 trial, or the Evolut low risk trial, the VITAL trial had a very high proportion of patients with a bicuspid aortic valve (42%), but the safety profile was very ideal, with an all-cause mortality rate of 31.4% at 7 years, which, despite the relatively high rate of pacemaker implantation, was closely related to the early phase of the trial and the large number of patients with bicuspid aortic valves, which is now believed to be easily reduced to about 10% with the ongoing maturation of TAVI technology."

Prof. Darren Mylotte:

"The design of the VitaFlow^® is based on the severe aortic valve calcification and bicuspid aortic valve anatomical morphology common in Chinese patients, and therefore the higher pacemaker implantation rate may be a considered choice when facing with this particular anatomical structures during actual clinical implantation. What's noteworthy is that ultrasound results at 7-year follow-up still showed high effective orifice area (EOA) and low transvalvular pressure difference, which is encouraging and raises our expectations."

VitaFlow^® series products and design concepts-Professor Darren Mylott

Technology and innovation in medical devices will undoubtedly be an important trend in the future development of medicine, and when facing with the enduring topic of how to further improve intraoperative valve maneuverability and bring safer and more effective treatment results for patients in the field of TAVI, MicroPort^® CardioFlow    launched VitaFlow Liberty^® with " motorized retrievable performance" as its solution, and invited Prof. Darren Mylotte to introduce the clinical advantages of its transcatheter aortic valve and motorized retrievable delivery system in detail.

Compared to the first generation TAVI product VitaFlow^®, VitaFlow Liberty^® 's foremost change lies in the world's first motorized retrievable delivery system. Firstly, the system facilitates easy deliverability of the valve through 360° range of motion in patients with complex anatomy, such as severe tortuous anatomies; secondly, the valve can be fully retrieved and repositioned even when released up to 75%, and physicians can be provided with up to 3 retrievable opportunities to further optimize valve implantation; and thirdly, the motorized retrievable delivery system effectively ensures the stability during release, reduces valve microdislogment, and makes the overall intraoperative procedure more portable for the physician.

VitaFlow Liberty^® also shows ingenious in valve design. On the basis of the highly acclaimed VitaFlow^® hybrid density cell and the design of the super-annular valve, it not only takes into account multiple surgical needs such as instrument delivery, valve coaxial, strong radial force, but also provides an ideal instrument choice for patients with severe calcification and bicuspid valve, and further increases the space of the valve with a special drum waist design. To help patients achieve better near - and long-term hemodynamic outcomes after surgery, it is worth noting that this benefit will be even more evident in VitaFlow Liberty^® models of 27 mm and 30 mm transcatheter aortic valves. In addition, the use of PET double layer skirt, large cell and bovine pericardial leaflets further optimized the results of intraoperative valve implantation and postoperative prognosis from different perspectives, such as reducing perivalvular leakage, preserving coronary access and providing long-term durability, respectively.

With the accumulation of high-quality evidence-based medical evidence, MicroPort^® CardioFlow announced the imminent launch of clinical studies targeting European patient groups and the expectation of obtaining CE certification for VitaFlow Liberty^® in the near future. The clinical data gathered post-approval will provide significant evidence-based support for the subsequent expansion of the valve system's indications.

Experts' comments

Prof. Oscar Mendiz:

"During the last 2 years, our team has applied VitaFlow^® and VitaFlow Liberty^® several times to perform TAVI on patients, we were impressed by the stability of the valve during deployment , even in extremely complex anatomical TAVI procedures, the valve’s anchoring remained consistent before and after deployment, and there were no severe incidents of valve displacement or slippage into the left ventricular outflow tract (LVOT). In addition, the valve could be slightly angulated for better coaxiality at 60% to 70% release."

Prof. Ole De Backer:

"The motorized retrievable delivery system offers the physician a very convenient practical experience, as the valve can be easily released at a fixed or self controlled speed by means of a specific knob indicated on the motorized handle. From my personal experience, due to the relatively large size of the outflow tract, the valve is extremely stable when released, neither slipping up into the ascending aorta due to high implantation depths or "oversizing", nor slipping down into the LVOT due to low implantation depths."

Prof. Angela Mclnerney:

"Unlike other self-expanding valves, the mixed-density stent structure used in the VitaFlow Liberty^® results in better radial support. The valve's PET double-skirt design also reduces the incidence of postoperative perivalvular leakage, and patients treated with the VitaFlow Liberty^® had very low transvalvular pressure differentials over a 12-month follow-up period. In addition, due to its excellent flexibility, the valve consistently maintains good coaxiality and stability when released."

A Case of TAVI with VitaFlow Liberty^® Application-Prof. Ole De Backer

With a TAVI for severe aortic stenosis, Prof. Ole De Backer further explains the strategy and clinical advantages of VitaFlow Liberty^®. The patient was a 78-year-old man, with a preoperative transthoracic echocardiogram (TTE) showing an LVEF of 55%, a peak/mean transvalvular pressure difference of 130/85 mmHg, and an aortic orifice area of 0.6 cm²; a preoperative CT showed an annulus of 24.1 mm in mean diameter, an LVOT of 23.5 mm in mean diameter, and a tricuspid aortic valve with heavily calcified leaflets, and coronary arterial openings of 20.0 mm and 18.3 mm on each side. The height of the coronary openings on both sides was 20.0 mm and 18.3 mm, respectively, and the annulus was at an angle of 48°, and the femoral artery access on both sides was fair.

An access was established through the right femoral artery, and the patient was hemodynamically stabilized and pre-expanded twice with a 22 mm balloon. The VitaFlow Liberty^® 27 mm transcatheter aortic valve was then slowly delivered along the guidewire to the base of the aortic sinus. Due to the small angle of the aortic arch, the delivery system was gently pushed during arch crossing to avoid damage to the vessel wall, and at the same time, the delivery system crossed the arch without interfering with the cerebral protection device. With the Cusp-overlap technique, the valve was precisely positioned 3 mm below the annulus after several adjustments, and the valve was released with rapid pacing at 160 beats/min. At 2/3 of the way through the release, the imaging showed adequate preexpansion, ideal valve position and expansion, and good visualization of the left and right coronary, and the valve was released completely. The valve release process was extremely stable, with little displacement of the valve. After withdrawal of the delivery system, final imaging showed no pressure gradient, no perivalvular leakage, and an LVEF of 54%, with the prosthesis securely anchored 3 mm below the valve, resulting in a favorable interventional outcome, the procedure was completed.

Prof. Ole De Backer:

"In the five TAVI procedures performed so far with VitaFlow Liberty^®, the patients selected were typically discharged the day after surgery without vascular complications, perivalvular leakage, or significant pressure gradient. The patients' intraoperative prosthetic valves were retrieved and re-released, and were found to be extremely stable and not prone to slipping or popping out of the valve. Therefore, from my personal experience, for those who are new to use the VitaFlow Liberty^®, choosing the fixed speed of the delivery system to release the valve may provide more stable and optimal release results, especially in challenging cases."

The future direction of the VitaFlow^® series-Prof. Darren Mylotte

While achieving fruitful success, MicroPort^® CardioFlow has not stopped the pace of innovation, and its third-generation TAVI product VitaFlow^® III is being accelerated in research and development.

According to Prof. Darren Mylotte, the VitaFlow^® III uses a unique "spatial steering " design, which enables large bending control in various procedures such as arch and valve crossing, retrieval, release and withdrawal, further improving valve coaxialness, device passability, as well as operational convenience and safety. Currently, VitaFlow^® III is available in 8 sizes with and without an intergrated sheath and can be adapted to 4 different valve models. It is worth mentioning that its FIM trial has been successfully completed, and the delivery system has shown good clinical efficacy during surgery.

Innovative technology colliding high-energy design, VitaFlow^® series products debut at PCRLV!

The VitaFlow Liberty^® and VitaFlow^®Ⅲ products on display at the bright lighting and high-tech MicroPort^® CardioFlow booth at the conference also attracted many experts.

Like the technology presented at the booth, VitaFlow Liberty^®, the world's only commercially motorized retrievable delivery system, is an innovative product born from the collision of modern medical care and cutting-edge technology, and has successfully kicked off the era of motorized retrievable delivery for the global TAVI field. Both the unique barrel-waist design of the valve itself and the original motorized handle-equipped delivery system provide reliable support for the successful completion of TAVI procedures. Especially with the motorized retrievable system, it becomes possible to complete TAVI surgery by a single physician, which may further help to optimize the clinical surgical process, thus making it more efficient and convenient.

VitaFlow^®Ⅲ, with its amazing debut as an bonus scene, will rely on the innovative design of "spatial steering " to bring better coaxiality and ideal valve implantation results to patients with large transverse hearts and those who have difficulty in overcurve, as well as provide better intraoperative experience for the physicians. This innovative product is expected to further improve the overall solution for structural heart disease and provide efficient intervention options for more different types of surgical challenges.

Summary

Innovative concepts create the industry's sharpest tools, and cutting-edge technology navigates the ideal future. As one of the most important pioneers in the heart valve field in China and around the world, MicroPort^® CardioFlow aims to actively promote the development of structural heart disease, and based on the innovative concept of " motorized retrievable". The VitaFlow^® series of products has successfully pushed the global TAVI field into an era of greater convenience, efficiency, and technology, and has been recognized and supported by many top experts and scholars in the field at home and abroad. The rich evidence-based medical evidence and accumulated surgical experience will further help to expand its new journey and bring a better therapeutic experience and a more comprehensive solution to the TAVI physicians and patients around the globe. We look forward to seeing the VitaFlow Liberty^® enter the European market as soon as possible and benefit more patients in Europe with its well-received " motorized retrievable" concept and ingenious valve design!