YeinHeart Unveils Next-Generation EVA-Pulsar™ Ventricular Assist Device and Files for IPO
EVAHEART
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In this era of rapid development in medical innovation, EVAHEART once again stands at the forefront of innovation in the field of artificial hearts (left ventricular assist devices).
On March 2, 2024, EVAHEART's "Artificial Heart Y Era: EVA-Pulsar™ New Product Launch" was held in Beijing. At the event, numerous renowned experts, entrepreneurs, and elites from various fields both in China and abroad bore witness.EVAHEART Launches the Latest Generation EVA-Pulsar™ Ventricular Assist Device.
This artificial heart integrates long-term implantation, ultra-small size, pulsatile blood flow, high-flow assistance, and bionic coating, providing patients with a safer, more effective, and comfortable long-term cardiac support. Moreover, EVA-Pulsar™ is the first in the industry to achieve full-flow channel design, further enhancing the safety of artificial hearts and ushering in a new era of innovation for future artificial heart development.
National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical SciencesAcademician Shengshou Hu,Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyProfessor Dong Nianguo, Japan Taiyo Medical Technology Research InstituteMr. Junichi Yamazaki, Chairman, Managing Director of Vivo Capital, Mr. Liu Weidong, Director of EVAHEART Medical, Ms. Yan Hua, Director and CEO of EVAHEART MedicalJointly attend the launch ceremony and witness this important moment of the opening of a technological revolution chapter with the guests present.
The Era of Artificial Hearts for Surgical Treatment of Heart Failure in China Has Arrived
Academician Shengshou HuEmphasize: The era of artificial hearts for the surgical treatment of heart failure in China has arrived. Thanks to the efforts and pioneering work of countless predecessors, the research and development of artificial heart devices in China have made rapid progress in the past few years. In 2019, the first artificial heart developed by EVAHEART was officially launched in China, marking a milestone moment in the development of artificial heart technology both in China and around the world.
Currently, the distribution of medical resources in China is uneven, and the incidence of heart failure patients continues to grow. Among them, approximately 7% are end-stage heart failure patients, who traditionally can only receive heart transplant treatment, while the number of donors is extremely scarce. From this perspective,Promoting the application and development of artificial hearts to meet the treatment needs of a large number of patients with severe heart failure is particularly important.At this stage, we need to further emphasize the standardization and quality control of artificial heart implantation, including proper selection of indications and postoperative rehabilitation, to improve patients' quality of life.
In the future, I hope everyone will work together to bring breakthroughs in the innovation of artificial heart technology in China, and bring good news to the treatment of many patients with severe heart failure.
Meanwhile, Academician Hu Shengshou also gave high praise to EVA-Pulsar™ at the conference:
"The new generation EVA-Pulsar™ not only retains the original product advantages, such as a maximum flow rate of 20L, powerful auxiliary capacity, and innovative full mainstream to reduce thrombosis, but also features a smaller size and significant improvements in implantation methods. These characteristics can not only help cardiac surgeons obtain better means to improve the quality of life for patients with advanced heart disease, but also provide more scientific assurance for numerous patients with advanced heart disease."
Ms. Hua Yan shared the innovative original intention of EVA-Pulsar™ at the beginning of the conference.
The artificial heart technology originated in the United States in the 1960s and was approved for marketing and promotion in the mid-1990s. However, before 2019, only developed countries such as Europe, the United States, and Japan possessed the relevant technology and conducted large-scale clinical applications; China had no similar products on the market. It wasn't until September 2019 that EVAHEART I, developed by Chongqing EVAHEART Medical Device Co., Ltd., gained approval, marking the beginning of the era of artificial hearts in China.
EVAHEART, building on the foundation of the first generation of EVAHEART, has paved an innovative path for the localization and development of artificial hearts in China.EVA-Pulsar™, developed over a decade by expert teams from China and Japan based on the clinical application and technical accumulation of EVAHEART Generation 1, inherits all the clinical advantages of EVAHEART Generation 1 while featuring new characteristics such as a smaller size and full-flow channel design.
A Decade of Dedication, Finally a Pump. At the press conference, Japan's Taiyo Medical Technology Research InstitutePresident Yamazaki ShunichiInvited to the scene, reviewed the ten-year R&D journey of EVA-Pulsar™, and from the perspective of technical development, explained the advantages of EVA-Pulsar™, namely:
· Small size, high flow, with pulse
· Weighs 262g, only 62% of the first generation
· The width of the flow channel and the size of the impeller remain unchanged, maintaining the original hemodynamic characteristics.
· The maximum flow rate remains at 20L/min, with the HQ curve unchanged.
· Blood flow is pulsatile, generating a pulse pressure difference of 20-30 mmHg.
With the release of EVA-Pulsar™, clinicians have a new option for treating end-stage heart failure patients, while the academic community also welcomes a new opportunity for medical exploration.
In order to promote the exchange of medical knowledge and the sharing of experience, the press conference specially invited Fuwai Hospital of the Chinese Academy of Medical Sciences.Professor Chen Haibo, The First Affiliated Hospital of Zhejiang University School of MedicineProfessor Ma Liang, Fujian Medical University Union HospitalProfessor Xiaofu Dai, President of Hokkaido Cardiovascular Hospital in Japan, Inventor of EVAHEARTProfessor Kenji YamazakiShared experience using EVA-Pulsar™ in clinical cases.
The experts present mainly pointed out,The surgery time for EVA-Pulsar™ is approximately 5 hours, and most patients can have the tracheal tube removed in a relatively short period. On the other hand, based on the product characteristics of the new generation EVA-Pulsar™, it can provide better conditions for minimally invasive implantation in clinical practice; offering enhanced support for critically ill and large-volume patients.In the long term, the characteristics of EVA-Pulsar™ pulsatile blood flow can also reduce the risks of postoperative right heart failure and aortic insufficiency, offering certain advantages for patients requiring long-term support.
The roundtable forum specially invited the founder of HartRhythm Cardiac Medical Group and the director of the Cardiology Department of Beijing Chaoyang Hospital, Capital Medical University.Professor Xingpeng LiuHosted by, The First Affiliated Hospital of Zhejiang University School of MedicineProfessor Ma Liang, Subei People's HospitalProfessor Tang Chengbin, the First Affiliated Hospital of Xi'an Jiaotong UniversityProfessor Yan Yang, The First Affiliated Hospital of Harbin Medical UniversityProfessor Xie Baodong, Jinan Central HospitalProfessor Zhang Fengquan、Sun Yat-sen University Sun Yat-sen Memorial HospitalProfessor Zheng JunmengThey also shared their expectations for the application of EVA-Pulsar™ and their outlook on future trends in artificial heart product applications.
Several experts coincidentally expressed similar views during the forum,With the improvement of LVAD technology, treatment outcomes have significantly improved. The efficacy of third-generation LVADs in treating end-stage heart failure is expected to approach or even surpass that of heart transplantation. The application of left ventricular assist technology in China has gradually gotten on track.
Future technological improvements in artificial hearts should focus on optimizing blood pump design, selecting materials with better blood compatibility to achieve permanent implantation, reducing complications, and developing high-energy batteries, efficient energy storage carriers, and wireless power sources. At the same time, changes in the spectrum of cardiovascular diseases have made the development and clinical application of ventricular assist pumps (for short-term and permanent implantation) one of the biggest hotspots in the cardiovascular field and a key direction for future development. The application of new interventional VADs may change the hierarchical treatment strategy for heart failure.
The 2024 China Heart Failure Device White Paper was simultaneously released at this press conference. With comprehensive data, this book provides a detailed and thorough compilation of the current state of heart failure diagnosis, treatment, and device research in China, offering relevant insights for experts and industry practitioners to understand the development trends in the heart failure sector.
The conference then announced that Professors Wang Xianqiang, Dai Xiaofu, Yan Yang, and Zheng Junmeng would be the EVAHEART Medical · 2024 Special Invited Teaching Experts. At the same time, Professor Xie Baodong, Professor Tang Chengbin, and Professor Zhang Fengquan were awarded the EVAHEART Medical · 2023 Excellence Award on-site.
As many experts emphasized at the conference, the era of artificial heart treatment has begun in response to the increasing number of heart failure patients.
In today's rapidly innovating and iterating medical device landscape, new products are constantly emerging while older ones are being revitalized, creating a complex, ever-changing, yet symbiotically positive dynamic. It is against the backdrop of continuous innovation in medical devices that patients with end-stage heart failure will undoubtedly have more treatment options, offering hope to further alleviate the severe shortage of heart transplant donors.
Overall, as the long-term treatment effectiveness of artificial hearts gains recognition, the trend in indications/purposes for their use will also evolve year by year. Strict quality control measures should be implemented regarding the application and promotion of artificial hearts to ensure their standardized and high-quality development.
Standing at the new starting point of the full release of EVA-Pulsar™, we believe that as EVA-Pulsar™ begins its widespread application after launch, an increasing number of heart failure patients will benefit. We are exploring a distinctive and innovative path for the development of artificial hearts, profoundly advancing the popularization of artificial heart technology in China.
The impeller of the artificial heart is spinning at high speed, boosting the development of China's heart failure treatment.
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