Source of the article: HeartFuture；Editor: SophiaReprint Requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.Recently,NMPA Announces the Review Results of the Special Review Application for Innovative Medical Devices (No. 9, 2024)Seven products have entered the innovation channel., includingAbiomed (Abiomed) CompanyApplicationImplantable Left Ventricular Assist System。Abiomed is a company focused on developingPercutaneous Ventricular Assist Device (pVAD)Medical device company, its core productImpella Series Heart Pumps(Not re-registered in China after 2017) plays an important role in global heart disease treatment.Impella is a mechanical circulatory support device.The device was retrogradely inserted into the aortic valve level via the femoral artery., is currentlyThe Only OneInterventional Artificial Heart Product Approved by the U.S. FDAIt is also the earliest commercialized product of an interventional artificial heart, known as "the world's smallest artificial heart."The product has been approved for use in the United States, the European Union, Japan, and other regions.Cardiogenic shock, left ventricular unloading (in conjunction with ECOM), high-risk PCI treatment, ventricular tachycardia ablation, and right ventricular failure。Imepella comes in various models.: Including Impella CP, Impella 2.5, Impella 5.0, Impella 5.5, Impella RP. The first four types are directly inserted via a retrograde approach through the aortic valve.Left VentriclePumping blood; Impella RP is inserted through the inferior vena cava into the pulmonary artery toRight Heart SystemProvide hemodynamic support.These models mainly differ in terms of flow rate, implantation method, and the length and diameter of the device.。
November 2022,Johnson & Johnson(NYSE: JNJ) announced that it will price at $380 per shareAcquisition of All Abiomed Shares for a Total Transaction Value of $16.6 BillionThrough this acquisition, Johnson & Johnson aims to further expand its market share in the cardiovascular treatment field and leverage Abiomed's technological advantages to enhance its product portfolio and market competitiveness. Abiomed will become part of Johnson & Johnson's medical technology business while continuing to operate independently.After the acquisition is completed, Abiomed announces its latest (as of 2024.10.22) interventional cardiac pump.Impella ECP Receives FDA Approval for Pivotal Clinical TrialThrough technological innovation, Impella ECP has achieved a smaller interventional size and higher flow. Johnson & Johnson also stated that it would further...Promote the global market expansion of Impella products, especially inChina and Southeast Asiain emerging markets, strengthening its market competitiveness.Impella SystemHistory of Product Development# Impella Series ProductsImpella Based onArchimedes Screw PumpPrinciple: Through an internal miniature axial flow pump,Pump oxygenated blood from the left ventricle directly into the ascending aorta to assist circulation.. In this way, it forms a blood flow path between the left ventricle and the ascending aorta, thereby helping to compensate for the insufficient function of the left ventricle.The core components of Impella includeMicro Axial Flow Pump(Responsible for inhaling and pushing blood towards the ascending aorta),Impeller(Participate in the suction and propulsion of blood),Cannula(Keep the blood flowing smoothly),Distal Pigtail Catheter(Placed directly inside the left ventricle, with a curved design to prevent direct contact with the ventricular wall during high-speed blood suction, avoiding damage).The inflow tract of the catheter is located in the left ventricle, generally 3.5 cm below the aortic valve, the outflow tract is located in the ascending aorta, and the pump body is located within the cannula.Speed up to 51,000 rpm, cardiac output of 2.5-6 L/min(Different products have different cardiac outputs),Diameter: 9-21Fr,The maximum usage time is 4-14 days.。
- Impella 2.5: The earliest Impella device, implanted via femoral artery puncture, can provide a maximum2.5L/min Blood Flow Rate, used clinically when necessaryShort-term (usually a few days) cardiac supportPatients.
- Impella CP: Implanted through femoral artery puncture, it can provide the maximum3.5L/min Blood Flow Rate, suitable for those in needMid-term (up to 14 days)Patients with cardiac support.
- Impella 5.0 and 5.5: Open-chest surgery or femoral implantation, providing maximum blood flow of 5.0L/min and 5.5L/min respectively, can provideLong-term (up to 14 days)Cardiac Support.
- Impella RP: Used to provideRight Ventricular Support, it isThe Only OneFDA Approves Artificial Heart Assist Device for Acute Right Ventricular Failure.
All Impella CathetersControlled by the same external drive consoleOperation, namely the Portable Automatic Impella Controller (AIC). The AIC generates the signals required to drive the motor for the Impella catheter and provides a user interface. The AIC also integrates a system that prevents blood from entering the Impella catheter’s drive motor, using a glucose heparin solution as the purge fluid.
Impella Controller (AIC)
Despite the excellent performance of Impella in clinical applications,But its built-in motor technology presents some challenges., such as hemolysis caused by oversized pumps and motor heating. To address these issues, Abiomed is developing the next generation of interventional cardiac pumps, such as adoptingExternal Motor TechnologyThe Impella ECP。Impella ECP is the world's smallest hemodynamic support heart pump.With a diameter of only 9Fr (3mm), it features an external motor design and blade folding technology., the cardiac pump can expand to approximately 18Fr, providing a peak flow rate of up to 5L/min, and is currently in clinical trials for circulatory support during high-risk PCI procedures.It should be noted that,Complications of Impella may occur during implantation, post-implantation, and removal., different contents need to be observed at different stages for prevention and treatment.# Product Market ProspectsChina has a large population base,The scale of patients with coronary artery disease reached approximately 26.6 million in 2022.。Percutaneous Ventricular Assist Device (pVAD) provides short-term support to heart disease patients by aiding or replacing the heart's pumping function. Compared with long-term use of Left Ventricular Assist Devices (LVAD),pVAD is suitable for acute situations, with the advantages of easy operation and lower cost.。
The clinical application goals and treatment durations of pVAD and LVAD are completely different.LVAD is mainly used for end-stage chronic heart failure patients, requiring long-term implantation to provide continuous cardiac support for patients awaiting heart transplantation, and sometimes even serving as a lifelong treatment solution. Therefore, the design of LVADs must possess a high degree of durability.
In contrast,pVAD is designed as a short-term use device, typically employed in emergency situations., such as providing intraoperative and short-term postoperative cardiac support for high-risk percutaneous coronary intervention (PCI) patients and cardiogenic shock patients. Therefore, the design of pVAD focuses more onMiniaturization, Portability, and Minimally Invasiveness。The price of pVAD is also lower, typically around 20,000 to 25,000 US dollars, while the average selling price of LVAD is as high as 175,000 US dollars.。
Currently, 4 LVADs of different technical routes have been approved in China., respectively from Core Medical, Unity Medical, Eternal Heart Medical, and Aerospace Tai Xin. However, due to the high technical barriers,In the field of percutaneous ventricular assist devices (pVAD), no domestically produced products have been approved for marketing in China.. Domestic enterprisesTalent Medical, HeartPower Medical, FengkaiLi Medical, Core MedicalAll have carried out product layouts, and Heart Power Medical and Fengkaili Medical have alsoTargeting Abiomed's in-development extracorporeal electrode Impella ECP series for strategic layout。
In January and July 2023, Fengkaili Medical and Core Medical's pVAD devices respectivelyThrough the NMPA's Special Review Procedure for Innovative Medical DevicesIn December 2023, Tongling Biomimetic's TeleHeart P50 clinical research was launched, successfully completing the first pVAD surgery in China to treat a patient with cardiogenic shock.
In this field, domestic manufacturers have also formed a relatively comprehensive R&D pipeline对标 overseas products, which is of great value for filling the gap in the domestic market for pVAD products.
