On April 12^th, 2022, Venus Medtech (Hangzhou) Inc. ("Venus Medtech", 02500.HK), a leading platform company for innovative structural heart disease therapies in China, announced the recent completion of the global first implantation in the First-in-Man (FIM) clinical trial of Venus-Neo, its self-developed next-generation expandable bioprosthetic dry-tissue valve, in Union Hospital of Tongji Medical College, Huazhong University of Science and Technology ("Wuhan Union"). 

This is another next-generation dry-tissue valve developed by Venus Medtech that has been put into clinical studies apart from Venus-Vitae and Venus PowerX. It extends the durability of bioprosthetic valve, helps to achieve Venus Medtech’s overall layout of aortic valve disease solutions, and consolidates the company's position as a leader in heart valve disease treatment in China.

The procedure was completed by a multidisciplinary team comprising Professor Dong Nianguo, Director of Cardiovascular Surgery Department at Wuhan Union, as well as Professor Liu Junwei and Professor Wang Yin.

The patient was a 67-year-old female who had suffered chronic cough with dyspnoea and was hospitalized due to recent deteriorating condition. Ultrasound detected moderate to severe aortic insufficiency, mild to moderate tricuspid insufficiency and mild mitral insufficiency. After evaluation, a surgical aortic valve replacement (SAVR) was performed with Venus-Neo. The valve opened and closed well with no regurgitation nor perivalvular leakage; the mean transvalvular pressure gradient was 7 mmHg with sound hemodynamics.

As Venus Medtech's first surgical bioprosthetic valve, Venus-Neo adopts a supra-annular design with bovine pericardial tissue as the leaflet. With optimized valve and unique anti-calcification dry process (Venus-Endura), the product can be stored in a fluid-free environment and contains no residual aldehyde, which makes it safer and easier for clinical use, storage and transport. In addition, the expandable design of the valve stent provides a better option for future valve-in-valve (ViV) treatment. In September, 2020, Venus Medtech started a joint venture, Jilin Venus Haoyue Medtech Limited ("Venus Haoyue Medtech"), with Jilin Changchun Haoyue Halal Meat Co., Ltd ("Haoyue Group"). This strategic partnership ensures a stable and high-standard supply of raw material.

Valvular heart disease (VHD) is one of the major diseases among the global elderly population1 with over 40 million patients worldwide2. With the aging of the Chinese population, aortic valve disease has become one of the major heart valve diseases. Aortic stenosis (AS) and aortic regurgitation (Aortic regurgitation (AR) are the two main categories, to which SAVR remains the more established treatment. However, it cannot be dismissed that a second SAVR after bioprosthetic valve failure is of high risk. In this condition, transcatheter aortic valve replacement (TAVR) is a viable alternative, and ViV TAVR is increasingly applied in the treatment of surgical bioprosthetic valve failure.

The latest 5-year follow-up data from the PARTNER2 ViV trial shows sustained improvements in clinical status and echocardiogram indexes after TAVR on patients with aortic valve bioprosthesis dysfunction, for whom operation poses high risk3. At the same time, the study suggests that an effective ViV-TAVR treatment to aortic valve bioprosthesis dysfunction is based on two essential factors: first, the size of implanted valve should be as large as possible to lay the foundation for the ViV treatment for future bioprosthetic valve failure; second, expandable bioprosthetic should replace the traditional fixed stent for better ViV-TAVR therapeutic effects.

 “It’s an honor to engage in the global first Venus-Neo FIM study," said Director Dong Nianguo after the procedure, “The bioprosthetic valve has better durability as the material of Venus-Neo can be directly preserved, which avoids residual aldehyde that occurs during glutaraldehyde preservation. The product is unique and innovative in that the expandable structure facilitates future treatment. And the postoperative echocardiogram showed that Venus-Neo has a large effective opening area and excellent hemodynamics."

Zi Zhenjun, Co-founder, Executive Director and General Manager of Venus Medtech said: "Venus Medtech has long been committed to the development and commercialization of structural heart disease medical devices, and has been devoted to solving the problem of valve durability from the source of biomaterials. This successful FIM of Venus-Neo helps the company achieve a full layout of aortic valve disease solutions, which not only provides more flexibility for clinical use and benefits more patients, but also promotes domestic innovative heart valves to a new level."

References:

1.      杜俣,刘巍,周玉杰.心脏瓣膜病治疗:经导管瓣膜治疗的适应人群——2020年ACC/AHA瓣膜病管理指南解读和思考[J].中国临床新医学,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.