CorWave Announces Global First-in-Human Implant of Its Novel Wave-Membrane-Based Left Ventricular Assist Device
CorWave
Cardiac Assist Device Developer
Heart Future
On July 9, 2025, CorWave SA, a French left ventricular assist device (LVAD) developerCorWaveAnnounced that its independently developedBased on Unique Wave Membrane TechnologyCorWave LVADSuccessfully Completed the World's First Human Implant Surgery in Australia.
This surgery, completed at St. Vincent's Hospital Sydney, marks a significant milestone in sustainable mechanical circulatory support technology.
Recently, aA patient with advanced heart failureAffectedCorWave LVADWorld's First Implant，CurrentlyThe surgery has been successfully completed and achievedPrimary Endpoint of 30-Day Survival Without Device-Related ComplicationsThe patient has now recovered and been discharged, stating, "I feel much better than before the surgery," no longer experiencing significant fatigue or difficulty breathing. The medical team continues to closely monitor the proper functioning of the device.
Currently in the U.S. market,Abbott (Abbott）Is the only LVAD supplier, itsHeartMate 3The equipment is widely used.
CorWave's innovative heart pump system, on the other hand, adopts the company's proprietaryWave Membrane Drive Technology，Inspired by the swimming mechanism of aquatic animals, aiming to achieve the protection of the physiological balance of the cardiovascular system.
Different from traditional rotary pumps (such asHeartMate Series (Continuous Fixed Flow Rate), CorWave's DeviceCan automatically adjust blood flow according to the patient's condition, achieving dynamic response.In the resting or active state of the patient, the system can operate in sync with the heartbeat rhythm, maintaining the pulsation effect of blood vessels, which helps to maintain cardiac structure and function.
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CorWave stated that its device designAiming to significantly reduce the serious complications commonly associated with existing LVADs, such as stroke, bleeding, heart failure, and valvular disease, etc., and is expected to improve patients' quality of life and promote the recovery of cardiac function.
CorWave CEO Louis de Lillers"This global first success stems from our unwavering pursuit of scientific research and engineering over the past decade. We thank the patients for their trust, the outstanding performance of the St. Vincent's Hospital team, and the steadfast support of our team, investors, and partners, which has made CorWave's vision a reality. We look forward to collaborating with the scientific and medical communities to usher in a new chapter in mechanical circulatory support, working together to improve the lives of patients with advanced heart failure."
# AboutCorWave LVAD
TraditionalLVADBased on the high-speed rotation of the rotor, the impeller is driven to bring blood out,Due to the shear force of the impeller and high temperature, this will cause relatively significant damage to the blood to some extent.; It is also prone to thrombosis and imposes higher design requirements on the machine.
CorWave LVAD Is a unique physiological behaviorLVAD, which adopts the CorWave technology, is used to treat patients with advanced heart failure.
The ProductInRestore Blood Flow While Maintaining High-Fidelity Pulsation, which is different from the continuous-flow rotary pump that provides limited pulsatility.Can SimulateNatural Heart: Continuously Rebuilding Ejection (Contraction) and Filling (Diastole) Phases Without Subjecting Blood to the Current Marketed Rotary PumpsLVADThe same damage.
CorWaveThe pump is designed to provide for the implant recipient.5-6 L/minThe average blood flow velocity, thereby providing comprehensive support for patients with advanced heart failure. Once the pump is implanted, power is supplied by a driveline cable, which passes through the skin and connects the pump to an external controller and battery. Its ability to reproduce physiological pulsatile flow is designed to reduce existing complications and improve the patient's quality of life.
The development of ventricular assist devices has experiencedThree Generations of Technological Innovation。
The 1st GenerationAs a pulsatile flow device, simulating the pumping function of the heart;
Generation 2For axial continuous flow devices;
The 3rd GenerationCentrifugal pumps can be divided into three types according to suspension technology: hydrodynamic suspension, magnetic-liquid suspension, and fully magnetic suspension. Compared with the first two generations, the third-generation centrifugal pump LVAD reduces mechanical contact and friction, lowering the risk of thrombosis and hemolysis.
CorWave LVADWith the3rd Generation Non-Two Differences Compared to Contact Centrifugal Pumps：
1. Physiological Flow Rate：Blood flows on the membrane at a physiological speed, approaching1-2m/s. The membrane exerts limited shear stress on blood cells, thereby maintaining the integrity of the blood, which is related to the blood flow exceeding5m/sThe speed of the rotating pump is different.
2. Pulsation Simulation：Unlike the third-generation non-contact centrifugal pump,CorWave LVAProviding pulsatile flow, frequency following heart rate,About per minute60Time。
Currently,CorWave LVADCan be performed through standard surgical procedures adopted by today's surgeons, including sternotomy.Or thoracotomy for implantation. Due to its compact design,CorWave LVADCan be implanted in the pericardial cavity and is compatible with minimally invasive surgery.
Core Technology——CorWave Pump
CorWave LVADAt the core is a disruptive patented technology: developed byJean-Baptiste DrevetThe invented wave membrane pump. The wave membrane pump is20The result of many years of research and development, capable of mimicking the heart. The wave membrane technology enablesCorWave LVADFundamentally different from the rotary pumps available on the marketLVAD, and makeCorWave LVADAndNemoCapable of providing unique physiological blood flow.
WaveWaveThe membrane is a biomimetic technology inspired by the undulating movements of marine animals. This movement provides an efficient way for the animals to move fluids and propel themselves through water.InCorWave LVADIn, the polymer membrane reproduces a similar but opposite interaction:The membrane is fixed, and the fluid (blood) is pushed.。
FromGIF availableIt can be seen that the wavy motion of the membrane is synchronized with the body's natural rhythm, changing with the speed of the blood flow in the human body, and automatically adjusting according to the patient's needs. In this regard,CorWave LVADIs with the currentVADThe principle of artificial heart is different, so more exercise can be performed with fewer restrictions, making it more humanized.
The movement of the wave can cause the membrane to take on different geometric shapes, especiallyDiscoidAndRectangle。CorWaveThe undulating membrane pump is driven by an electromagnetic actuator, causing the polymer membrane to vibrate and converting the propagation of waves along the membrane (like a speaker) into the driving force for blood propulsion.
# Relevant Clinical Studies
2025April 24，CorWave Announces Preclinical Trial ResultsCorWave LVADIt has been safely operating in animals for 6 months. In addition,WillCorWave LVADImplantation in 9 SheepIn-body TechniqueAfter60 Days,NotAnticoagulant drugs can also be used safely with the device.Not appearedAny malfunction, also when removingNo thrombus detected. This preclinical study demonstrates the device's antithrombotic properties, algorithm stability, and blood compatibility, also markingCorWave is about to enter the clinical trial stage。
Cardiac SurgeonMartin StrueberSay:“This technology is expected to reshape the field of long-term mechanical circulatory support, overcome the limitations of existing rotary blood pumps, and achieve truly intelligent and adaptive circulatory support. Preclinical results are outstanding, with additional six-month animal experiment follow-ups showing excellent pump performance. It is anticipated to move into clinical trials.”
AnotherCardiac SurgeonSebastian Schulte EistrupIndicates:“CorWave LVAD Demonstrates Excellent Preclinical Results: No Device-Related Failures or Complications. Smooth Surgical Implantation, New Control Algorithm Enables Synchronous Support (Systolic/Diastolic Modes), Reliable Operation Throughout, with Safety and Feasibility Verified.”
# Domestic Similar Competitive Products
As of now, the National Medical Products Administration (NMPA) has approved a total of4Implantable devices from Chinese companiesLVAD, respectivelyEtern Heart Medical(Long-termLVAD）、Concentric Medical(Short-termLVAD), Aerospace Taixin (Short-termLVAD) and Core Medical (Short-termLVAD）。
Eternal Heart MedicalEVAHEART
Eternal Heart Medical's core product is the implantable left ventricular assist device.–“EVAHEART"YongRenXin" Artificial Heart. The product isCurrently, the only artificial heart in China approved for both short-term and long-term treatment with dual indications., alsoThe only bionic artificial heart with biomimetic pulsatile blood flow。
Eternal Heart Artificial Heart2020Year1Awarded by the Chinese Academy of Medical Sciences in2019Certificate of Major Advances in Chinese Medicine in [Year]" and selected for CCTV "2019Top Ten Scientific and Technological Achievements in China in 2022", and has been officially approved for use in Japan and Europe, and obtained in the United StatesIDEPermit, widely used.
Product Features:EVAH IImplantable Left Ventricular Assist DeviceEART I It is the first registered and marketed ventricular assist device in China, utilizing hydrodynamic suspension technology to generate pulsatile blood flow, effectively maintaining vascular elasticity and reducing the incidence of aortic valve insufficiency and gastrointestinal bleeding.
Clinical manifestations:Postoperative Patients in Clinical Trials1Annual survival rate reached100%, the longest auxiliary time has exceeded10Year.
Market Position:2019Year8Month,EVAHEART IApproved by the National Medical Products Administration for marketing, becoming the only artificial heart in China approved for long-term assistance, marking the entry of China's severe heart failure treatment into the "artificial heart era."
Eternal Heart MedicalEVA-Pulsar™
EVA-Pulsar™ is a trademark of YongRenXin Medical inEVAHEARTA new generation of implantable left ventricular assist device developed on the basis of the first-generation product (LVAD), inheriting and optimizingEVAHEARTThe core technology and clinical advantages of the first generation.
▲EVA-Plusar™ Components of the Implantable Left Ventricular Assist Device
Product Features:EVA-Pulsar™ is the new generation of artificial heart product from YongRenXin Medical, featuring ultra-small size, ultra-large flow, pulsatile blood flow, high-flow assistance, and bionic coating, among other advantages.
Clinical Trial:The product has been approved for marketing by the National Medical Products Administration, and has also been approved in Japan and the United States.FDAProceedCOMPETENCEClinical trials, andHeartMate IIIPerform head-to-head comparison.
Market Position:2023Year,EVA-Pulsar™ has been approved for marketing by the National Medical Products Administration, becomingIn China2Artificial heart approved for long-term implantation and the first in China5Artificial heart approved for marketing in China。
Concentric MedicalCH-VAD
Concentric Medical adopts the new generation of magnetic levitation technology, under its umbrellaCH-VADImplantable Left Ventricular Assist System2021Year11Approved for marketing by the National Medical Products Administration (NMPA) in [Month], becoming China's...China's First Fully Magnetically Levitated Artificial Heart Breaks Abbott's MonopolyAt the same time, with the latest breakthroughs in key performance indicators such as hemocompatibility, implant invasiveness, and anti-infectivity, CH Biomedical has gained an international reputation as a technological breakthrough leader, continuously demonstrating its strength as a global technology and market leader.
▲CH-VAD
CH-VADMainly composed of an implanted part and an external part, the core component, the blood pump, is a special and precise centrifugal pump that can fit in the palm of your hand. Its impeller is supported by magnetic suspension bearings and rotates under the drive of a brushless DC motor. The external controller manages power supply, monitors and adjusts the status of the blood pump, and provides a user interface. The entire system combines software and hardware, and must meet extremely high requirements for reliability, medical device safety, and electromagnetic compatibility.
Aerospace TaixinHeartCon
HeartConAlso known as the "Rocket Heart," it was jointly developed by the China Academy of Launch Vehicle Technology and Tianjin TEDA International Cardiovascular Hospital (hereinafter referred to as TEDA Hospital). It is a domestically produced implantable left ventricular assist system with full independent intellectual property rights in China.
▲HeartConImplantable Left Ventricular Assist System (Source: Company Official Website)
2013Year, Test Sheep "Tian Jiu" Survived Healthily120Days, setting five firsts, including the longest survival record in China;2018Year, the product passed the special approval for innovative medical devices.2022Year7Month,HeartConApproved by the National Medical Products Administration for short-term auxiliary use, becoming the first in China2The first approved self-developed ventricular assist device.
HeartConBelongs to the current third-generation implantable magnetic-liquid suspension ventricular assist device. This device adopts a technical solution of magnetic-liquid dual suspension, pump-motor integration, and system dual redundancy, featuring a small volume, light weight, low hemolysis, and minimal thrombosis. In addition, the second-generation implantable artificial heart developed by this company——HeartConⅡ, the world's first third-generation fully magnetically levitated blood pump without active magnetic bearings and position sensors, being the lightest in weight and smallest in size. It is currently undergoing registration testing and animal experiments, with expectations for...2024Clinical trials launched in the year.
Core MedicalCorheart®6
Corheart®6It is a domestically developed implantable fully magnetically levitated artificial heart, used to provide hemodynamic support for patients with advanced refractory left heart failure. The blood pump has a diameter of only34mm, Thickness26mm, Weight approximately90g, with a diameter smaller than similar products on the market40%`, Weight loss`50%, according to the company, isThe World's Smallest and Lightest Artificial Heart Currently。
2024Year5In the month, Core Medical initiated European clinical trials and successfully enrolled patients; at the same time, Core Medical is carrying out international expansion in multiple locations.2025Year6Month,Corheart®6Landed in the Americas, obtained market access approval in Colombia, and successfully completed the first overseas commercial implantation of a domestically produced artificial heart.
Corheart®6Composed of implanted components, external components, and surgical accessories, used in conjunction with specific artificial blood vessels to provide mechanical support for blood circulation in patients with advanced refractory left heart failure, serving as a transitional treatment before heart transplantation or for the recovery of cardiac function. The product is a third-generation non-contact magnetic levitation centrifugal pump, with core technology primarily based on disc motor technology, which uses position sensors to detect and control the rotor's speed and suspension height. The motor employs only a single set of stator coils to simultaneously control the rotation and suspension of the rotor, 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 broader, and it reduces the risk of thrombosis caused by blood pump heat.
According to the company, as a representative of the new generation of miniaturized fully magnetically levitated artificial hearts,Corheart®6Through excellent structural and motor design, the challenges of thrombosis and bleeding potentially caused by prolonged use of artificial hearts have been successfully addressed, effectively ensuring patient survival rates and significantly improving postoperative quality of life.
Relevant tests and clinical data show,Corheart®6Implantable left ventricular assist devices have demonstrated outstanding performance in terms of infection risk prevention and control, device reliability, and blood compatibility, reaching an internationally leading level.
# AboutCorWave
CorWaveFounded in2011Year, headquartered in Paris, France, its core products includeCorWave LVADAndNemo。
LVADIt is an implantable cardiac assist pump designed to treat patients with end-stage heart failure;NemoIt is an implantable minimally invasive cardiac pump designed for patients who are not suitable forLVAD And currently provides chronic, partial support for heart failure patients without appropriate treatment.
As of now,CorWave has completed a total of4 Rounds of Financing, itsFinancing Process is as follows:
2013 YearCompletedAWheel,The financing amount is330Million Euros (2646Ten Thousand RMB)；
2016 YearCompletedBWheel,The financing amount is1550Million Euros (1.24100 million RMB)；
2021 YearCompletedCWheel,The financing amount is3500Million Euros (2.8100 million RMB)；
2023 Year6MonthCompletedC+Wheel,The financing amount is6100Million Euros (Nearly5100 million RMB)。
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