Source: Siyu MedTech; Editor: Qi Yuan
Reprint requirements: Can be reprinted 24 hours after the first publication, source must be cited.
Recently,Abbott HeartMate 3™ Implantable Left Ventricular Assist System(Hereinafter referred to as HeartMate 3™) has been approved by the National Medical Products Administration (NMPA).. This approval will provide a new treatment option for Chinese patients with advanced heart failure, helping to improve long-term survival rates and quality of life.
HeartMate 3™YesThe world's first approved and currently onlyLeft Ventricular Assist System Simultaneously Certified by NMPA, CE, and FDA。
China has 8.9 million heart failure patients[1]。Once heart failure reaches the end stage, patients are often unable to perform any physical activities. Heart transplantation or implantable left ventricular assist systems are the preferred treatment options for patients with end-stage heart failure.HeartMate 3™, as the third-generation product in the HeartMate™ series, inherits multiple technical advantages while introducing the exclusive Full MagLev™ fully magnetically levitated flow technology for the first time.Utilizing a wide and fully sintered titanium surface blood flow channel for stable and gentle blood processing, thereby minimizing complications and enhancing blood compatibility.HeartMate 3™ isThe Only Fully Magnetically Levitated Left Ventricular Assist Device with Artificial Pulse, the pulsatility index can transmit heart pulsation in real time and with precision. HeartMate 3™ Battery PackCapable of providing 17 hours of power with a built-in backup battery, ensuring power supply while avoiding the risk of emergency power outages.Since its approval by the U.S. FDA in 2017,The global cumulative implantation volume of HeartMate 3™ has exceeded 33,000 cases.*, is a safe short-term and long-term support treatment option for patients with end-stage heart failure. The HeartMate™ series offers significant survival benefits.The longest survival benefit for patients with implants has reached up to 15 years.**。STS-Intermacs (Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support) Latest 2023 Annual Report compares detailed information of patients implanted with the fully magnetically levitated device HeartMate 3™ and non-magnetically levitated devices over the past decade.The results showed that the implantation of the full magnetic suspension device HeartMate 3™ could safely and effectively improve patients' short-term and long-term survival rates, with a significant reduction in critical adverse events.[2]。▲ Abbott HeartMate 3™ Implantable Left Ventricular Assist SystemHeartMate 3™ has the only 5-year and largest-scale clinical trial data to date.[3], the results showed that it was able to extend the survival period of patients with advanced heart failure to at least 5 years (with a median survival time far exceeding 5 years)., bringing significant survival benefits to patients[4]。
In addition, real-world data of HeartMate 3™ shows end-stage heart failure patients who received their first implant of HeartMate 3™.The 5-year overall survival rate reached 64%., among which the 5-year survival rate of patients under 50 years old reached 76%.[5]; The 6-minute walk test results of the patient increased to about three times the baseline and remained stable, and the patient's EQ-5D VAS score improved by over 80%, significantly and continuously enhancing the patient’s functional status and quality of life.[6]。
▲Data show that the 5-year overall survival rate of end-stage heart failure patients who received their first implant of HeartMate 3™ reached 64%, higher than the survival rate of high-risk heart transplant patients.[7], among which the 5-year survival rate for patients under 50 reached 76%.
As a leader in comprehensive solutions for heart health, Abbott consistently focuses on the diagnosis and treatment of cardiovascular diseases in China and the growing health demands. It is committed to bringing significant innovations of great medical value to the industry and advancing the treatment of heart diseases, enabling more patients to regain their health and create wonderful lives."Abbott Heart Failure"Official WeChat Public Account (WeChat ID: AbbottHeartFailure) is actively being prepared and will officially launch online on August 8.Welcome to follow the official account, delve into the forefront of heart failure disease treatment, and learn more about the HeartMate 3™ product information.Together, we safeguard heart health and create a vibrant life.
[1] "Report on Cardiovascular Health and Diseases in China 2022"* Abbott archived data. Based on clinical and device tracking data as of November 10, 2022.[2] Jorde UP, Saeed O, Koehl D, et al. The Society of Thoracic Surgeons Intermacs 2023 Annual Report: Focus on Magnetically Levitated Devices. Ann Thorac Surg. 2024;117(1):33-44. doi:10.1016/j.athoracsur.2023.11.004[3] https://abbott.mediaroom.com/2022-08-29-New-Data-Show-Abbotts-HeartMate-3-TM-Heart-Pump-Extends-Life-Beyond-Five-Years-for-Advanced-Heart-Failure-Patients[4] New Data Show Abbott's HeartMate 3™ Heart Pump Extends Life Beyond Five Years for Advanced Heart Failure Patients – Aug 29, 2022 (mediaroom.com) https://abbott.mediaroom.com/2022-08-29-New-Data-Show-Abbotts-HeartMate-3-TM-Heart-Pump-Extends-Life-Beyond-Five-Years-for-Advanced-Heart-Failure-Patients[5] Jorde UP, Saeed O, Koehl D, et al. The Society of Thoracic Surgeons Intermacs 2023 Annual Report: Focus on Magnetically Levitated Devices. Ann Thorac Surg. 2024;117(1):33-44. doi:10.1016/j.athoracsur.2023.11.004[6] Jan D Schmitto, Steven Shaw, Jens Garbade, Finn Gustafsson, Michiel Morshuis, Daniel Zimpfer,Jacob Lavee, Yuriy Pya, Michael Berchtold-Herz, AiJia Wang, Carlo Gazzola, Evgenij Potapov, Diyar Saeed, on behalf of the ELEVATE Registry Investigators, Fully magnetically centrifugal left ventricular assist device and long-term outcomes: the ELEVATE registry, European Heart Journal, Volume 45, Issue 8, 21 February 2024, Pages 613–625, https://doi.org/10.1093/eurheartj/ehad658[7] Kilic, et al. Factors associated with 5-year survival in older heart transplant recipients. J Thorac Cardiovasc Surg. 2012;143:468-74.
Editor-in-Chief | Zhao Qing Reviewed by | Yi He
