Venus-Neo expandable biological stem valve successfully completed the world's first clinical application

On April 12, Hangzhou Qiming Medical Devices Co.
, Ltd.
(“Qiming Medical”, 02500.
HK), China’s leading comprehensive platform for innovative devices for structural heart disease, announced that its self-developed new-generation expandable biological stem valve Venus- Neo, recently successfully completed the world's first clinical trial applied to humans (First-in-Man, FIM) at Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology ("Wuhan Union")
.
After Venus-Vitae and Venus-PowerX, Venus-Vitae is another new generation of stem valve product that has entered clinical research, marking that while improving the service life of biological valves, Venus-Medical realizes the full layout of aortic valve disease solutions , which is a milestone in consolidating the company's leadership in the field of valvular heart disease treatment in China
.
The clinical trial was jointly completed by a multi-disciplinary team composed of Professor Dong Nianguo, director of the Department of Cardiovascular Surgery of Wuhan Union Medical College, and Professor Liu Junwei and Professor Wang Yin
.
A 67-year-old female patient was admitted to the hospital with a chronic cough with dyspnea that had recently worsened.
Ultrasound showed moderate to severe aortic regurgitation, mild to moderate tricuspid regurgitation, and mild mitral regurgitation
.
After evaluation, Venus-Neo was used to perform Surgical Aortic Valve Replacement (SAVR), and the valve opened and closed well, without regurgitation and paravalvular leakage; the artificial valve flow rate was 1.
4m/s, and the average transvalvular pressure difference 7mmHg, excellent hemodynamic performance
.
As Qiming Medical's first surgical biological valve, Venus-Neo adopts a supra-annular valve design and uses bovine pericardium tissue as valve leaflets.
Through optimized valve design and unique anti-calcification drying treatment technology (Venus-Endura), it can be placed in fluid-free It can be stored in the environment and does not contain aldehyde residues, which is convenient for clinical use, storage and transportation while improving safety
.
In addition, Venus-Neo's valve stent adopts an expandable design, providing a better choice for patients who need to receive "valve-in-valve" therapy in the future
.
In September 2020, Qiming Medical and Changchun Haoyue Halal Meat Co.
, Ltd.
established a joint venture company - Jilin Qiming Haoyue Biotechnology Co.
, Ltd.
This strategic cooperation ensures a stable and high-standard raw material supply system
.
Valvular heart disease (VHD) is one of the major diseases of the elderly in the world [1], with more than 40 million patients worldwide [2]
.
With the aging population in China, aortic valve disease has become one of the major heart valve diseases, mainly Aortic Stenosis (AS) and Aortic Regurgitation (AR)
.
For the treatment of AS and AR, SAVR is still a relatively mature treatment
.
However, the high risk of repeated SAVR after bioprosthetic valve failure cannot be ignored
.
For such patients, transcatheter aortic valve replacement (TAVR) is a viable alternative to repeat SAVR, and valve-in-Valve (ViV) TAVR has been gradually applied to surgical bioprosthetic valve failure treatment
.
The newly published 5-year follow-up data of the PARTNER2 ViV trial showed that patients with aortic valve bioprosthetic valve failure at high surgical risk who underwent TAVR intervention continued to improve their clinical status and echocardiographic results [3]
.
At the same time, studies suggest that ViV-TAVR is effective in the treatment of aortic valve bioprosthetic valve damage, based on two necessary factors: 1.
The implantation of the largest possible size valve should be given priority, and ViV should be performed for future bioprosthetic valve failure.
Lay a good foundation; 2.
Improve the biological valve fixed by the traditional valve frame structure, bring better therapeutic effect for ViV-TAVR after the biological valve decay, and apply the expandable valve
.
Director Dong Nianguo said after the operation: "It is a great honor to participate in the world's first FIM study of Venus-Neo
.
Venus-Neo's dry valve material can be stored directly, effectively avoiding aldehyde residues that occur through glutaraldehyde preservation, thereby greatly improving valve durability; the expandable structure design of the valve frame also provides sufficient convenience for patients' future treatment.
It is a unique and innovative product
.
The postoperative ultrasound showed that the Venus-Neo had a large effective opening area and excellent hemodynamic performance
.
Zi Zhenjun, co-founder, executive director and general manager of Qiming Medical said: "For a long time, Qiming Medical has been committed to the research and development and commercialization of structural heart disease medical devices, and insists on solving the problem of biological valve durability from the source of biological materials.

.
The successful FIM of Venus-Neo helps the company to realize the full layout of aortic valve disease solutions, which not only provides more flexibility for clinical use and benefits more patients, but also helps domestic innovative valves to move to a new level
.
References: [1].
Du Ma, Liu Wei, Zhou Yujie.
Treatment of heart valve disease: suitable population for transcatheter valve treatment--Interpretation and thinking of the 2020 ACC/AHA management guidelines for valve disease [J].
New Clinical Medicine in China ,2021,14(06):534-539.
[2].
Davidson LJ, Davidson CJ.
Transcatheter treatment of valvular heart disease: A review[J].
JAMA, 2021, 325(24): 2480-2494.
[3 ].
Hahn RT, Webb J, Pibarot P, et al.
5-Year Follow-Up From the PARTNER 2 Aortic Valve-in-Valve Registry for Degenerated Aortic Surgical Bioprostheses[J].
JACC Cardiovasc Interv.
2022, 15(7) :698-708.