Recently, EVAHEART announced that the company has developed a new generation of ultra-small, long-term artificial heart "EVA-Pulsar™ Left Ventricular Assist DeviceHas obtained the medical device registration approval from the National Medical Products Administration (NMPA), becomingThe Fifth Artificial Heart Approved for Marketing in China.

The other four products are: EVAHEART I from Yongrenxin Medical, CH-VAD from Tongxin Medical, HeartCon from Hangtian Taixin, and Corheart6 from Core Medical. Among them, only EVAHEART I from Yongrenxin Medical can be used for long-term assistance, and EVA-Pulsar is also the successor to EVAHEART I.Currently, the second domestically approved artificial heart that can be used for long-term implantation in China.

Image Source: Yanda Medical Network

According to the introduction, EVA-Pulsar integratesLong-term implantation, ultra-small volume, pulsatile blood flow, high-flow assistance, bionic coatingWith advantages such as a reduced size to 60% of the previous generation product EVAHEART I, a weight of only 262g, and still maintaining a super large flow rate of 20L/min, which is twice that of other products on the market. The launch of this product not only solidifies EVAHEART's leading position in the industry but also fills the gap in China's long-term artificial heart market.

Moreover, in terms of volume and weight, EVA-Pulsar has also achieved a revolutionary improvement.Thanks to the optimization of the drive system and flow channel design, the volume of EVA-Pulsar has been significantly reduced, weighing only 260g, which is 64% of EVAHEART I.

It is worth noting that, despite the reduction in size of EVA-Pulsar, there has been no compromise in performance. Like EVAHEART I, it utilizes a biomimetic polymer MPC coating that resists thrombosis. The 20L/min high blood flow meets the physiological needs of patients, and compared to other products with speeds exceeding 4000rpm, the blood pump speed of EVAHEART is only about 1600-2200rpm. This lower speed effectively reduces shear stress on the blood from the impeller rotation, significantly...Reduce its destruction to the blood.

In addition，EVA-Pulsar has also been approved for two indications: short-term assistance and long-term treatment.It has currently been approved for marketing by Japan's Pharmaceuticals and Medical Devices Agency (PMDA) and is undergoing the COMPETENCE clinical trial with the US FDA, in a head-to-head comparison with HeartMate III.

Early results of the COMPETENCE trial show,The survival rate and heart failure recovery effect of EVA-Pulsar™ showed no significant difference compared to HeartMate III, but its 90-day stroke-free survival rate (100%) was significantly higher than that of HeartMate III (62.5%).

In addition to these two artificial hearts from EVAHEART,Four products have been approved for marketing in China:CH-VAD, HeartCon, Corheart6.

However, these products are only approved for short-term transitional treatment. According to the technical evaluation report on the website of the Center for Medical Device Evaluation of the National Medical Products Administration, the short-term transitional LVAD products are evaluated for clinical safety and effectiveness over a period of 3 months, and patients surviving with the device for 3 months are considered to have met the standard.

Corheart 6

Corheart 6, developed by Core Medical, is the world's smallest and lightest full magnetic levitation centrifugal left ventricular assist system with the longest battery life.As of now, Corheart® 6 has achieved numerous industry breakthroughs:Implanted in over 120 patients, ranking first in China for the number of implants and achieving the most clinical applications in the country; completed clinical enrollment in 159 days, breaking the industry's clinical speed record.

It is reported that,Corheart 6 Blood Pump: Diameter of 34mm, Thickness of 26mm, and Weight of Only 90 Grams. In Terms of Blood Pump Technology, This Product Utilizes Third-Generation Non-Contact Magnetic Levitation Centrifugal...Pump,The core technology is mainly the disc motor technology, which uses position sensors to detect and control the rotor's speed and suspension height. The product's motor only uses one set of stator coils to simultaneously control the rotor’s rotation and suspension, featuring a simpler structure, lighter weight, smaller size, and lower power consumption. In clinical applications, the surgical incision is smaller, patient recovery is faster, the applicable population is wider, and it can reduce the risk of thrombosis caused by blood pump heat.

At the same time, the range of people suitable for the product has been further expanded.Can be applied to high-risk patient groups such as children and overweight individuals.In addition, the lightweight design of Corheart 6 can reduce gravitational traction on the myocardium, minimize mechanical interference with reverse myocardial remodeling, and is more conducive to cardiac recovery treatment.

Compared with similar international products, the key performance indicators of Corheart® 6 have reached the same level, and it has set several records both in and outside China, significantly enhancing the competitiveness of domestically produced artificial hearts in the international market.

HeartCon (HeartCon)

In 2013, the experimental sheep "Tianjiu" survived healthily for 120 days, setting five firsts including the longest survival record in China. In 2018, the product passed the special approval for innovative medical devices. On July 13, 2022, HeartCon received approval from the National Medical Products Administration for short-term assistance, becoming the second domestically developed ventricular assist device to be approved in China.

CH-VAD (Concentric Medical)

However, due to the severe shortage of heart donors in China, a large number of patients die while waiting for a heart transplant, and only one in a thousand patients have the opportunity to receive a heart transplant.2From 2015 to 2020, only 2,819 heart transplants were completed, with an average of less than 500 cases per year.As the most effective treatment option aside from heart transplantation, artificial hearts have become another千亿-level blue ocean market following coronary stents and interventional valves.

Over 500 Clinical Implants

Data shows,Since Fuwai Hospital pioneered the Chinese-made implantable LVAD surgery in 2017, a total of 82 implantable left ventricular assist device implantation surgeries have been completed as of March 2023.，Including three ventricular assist devices: EVAHEART I from Chongqing EVAHEART, CH-VAD from Suzhou Tongxin, and Corheart6 from Shenzhen Core.

During the same period,A total of 363 implantable ventricular assist devices have been applied in 70 hospitals across China. Additionally,By October of the same year, 85 hospitals across China had completed more than 500 implants.Across China, 16 hospitals have implanted more than 10 cases, 8 hospitals have implanted 6-9 cases, and 61 hospitals have implanted 1-5 cases, mainly concentrated in hospitals in the central and eastern regions.

DespiteThe artificial heart industry in China is still in its infancy, butIn addition to the few companies with approved products, there are alsoHeartPower Medical, JiuAn Artificial Heart, TongLing Bio-Mimicry, HeartPeak MedTech, FengKaiLi Medical, HeartEver Power, DiYuan Medical, HeartPeak MedTechCompanies have begun to layout in this field.

NyokAssist

Among them,NyokAssist Minimally Invasive Artificial Heart by Xinqu Medical on February 4 this yearApproved Innovative Medical Device Enters Special Review Channel.According to reports,The product has successively obtained the FDA's "Breakthrough Device" designation in the United States and the innovative medical device approval from the National Medical Products Administration within half a year, becomingThe world's only interventional artificial heart to simultaneously achieve "innovation approval in both China and the U.S."It is another important milestone for high-end medical devices produced in China.

NyokAssist adopts an innovative foldable impeller design, featuring the world's smallest interventional size of 9Fr (3mm), which can minimize bleeding, reduce the occurrence of perioperative and postoperative vascular complications, and meet the needs of patients with finer blood vessels or arterial stenosis.After entering the body,The impeller can quickly expand to an operating size exceeding 21Fr.Thus, while achieving greater flow, it operates at a lower rotational speed, reducing the damage to blood cells caused by the high-speed rotation of the impeller.

Foldable impeller design enables greater flow at lower speeds.

In addition, NyokAssistThe external motor design effectively avoids hemolysis caused by the heat generated when the motor is placed inside the body.China has a huge volume of HRPCI surgeries, and using high-value motors as reusable components can effectively reduce costs, demonstrating significant health economic value.

--

Survey data shows that as of September 2022, the total number of patent applications related to artificial hearts in China was 1,134. Among them, Core Medical...The largest number of patents is 47, followed by Aerospace Tyeheart Technology (42), and Anhui Tongling Biomimetic Technology (29). It is expected that there will be more innovations in the future, including the use of new materials, higher energy efficiency, and longer device lifespan.

It is worth mentioning that EVAHEART is the only company in China that owns long-term artificial heart technology. The completion of this product iteration also means it has mastered two of the only long-term artificial heart blood pumps in China, and its future development potential cannot be underestimated. Medical Device Frontline will continue to follow up.

END

 

More exciting content

Welcome to follow WeChat Video Channel

Instrument Family

Related Reading

Tap for more!

Firing the CEO, TOP 6 Diagnostic Giant May Be Acquired

Medical Device Giant: Official Split on April 1

Please take your seats! Looking at service organization transformation from "Hot and Steamy"

Medtronic Officially Announces: Exiting This Business

"King of Chinese-made Rigid Endoscopes" "Battle of the Second Round" at the Beijing Stock Exchange

A Decade's Promise: Boston Scientific Invites You to a Cloud-Based Journey Across Time and Space

Centennial Giant Halts Production, Lays Off 1,300

Mindray Medical Teams Up with "Shanghai's Largest Real Estate Developer"

Shenzhen Trillion, Shanghai Billion Medical Device Plan Arrives

75 Billion, the Largest Acquisition of the Year

BusinessBusiness cooperation email: qxzj@landianyiliao.com