Source: Heart Future; Editor: Sophia
Reprint Requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.Recently,Medtronic (NYSE：MDT）Shared itsLong-term Results of the Global Pivotal Trial for the Aurora Extravascular Implantable Cardioverter Defibrillator (EV-ICD).Dr. Francis Murgatroyd from King's College Hospital London presented the research findings at the 2024 ESC (European Society of Cardiology) Congress,Highlighted the long-term benefits of receiving Medtronic extravascular defibrillator therapy for patients at risk of sudden cardiac death.。
Aurora EV-ICD System isThe Only One in the WorldCanProvided simultaneouslyCardioversion Defibrillation, Anti-Tachycardia Pacing (ATP), and Pause Prevention Pacing (PPP)FunctionTheExtravascular Implantable Defibrillator, alsoThe First ProductICD with defibrillation electrode leads placed at the left sternal border and pericardial surface. While ensuring safety,Positioning the electrode closer to the heart requires lower defibrillation energy and extends the device's service life.。
Aurora EV-ICD™ and its dedicated Epsila EV™ implantable leadReceived FDA approval in October 2023，Now available in 29 countries worldwideIn July 2024, it was successfully carried out at Ruijin Hainan Hospital in Boao, Hainan.First Case in ChinaExtravascular Implantable Cardioverter Defibrillator (Aurora EV-ICD™) Implantation。
Aurora EV-ICD Schematic DiagramAurora The EV ICD Pivotal Trial is a prospective, multicenter, single-arm, non-randomized, pre-market clinical study evaluating the safety and effectiveness of the Aurora system in patients at risk of sudden cardiac death.Researchers in 17 countries across North America, Europe, the Middle East, Asia, Australia, and New ZealandA total of 356 patients were recruited at the location, andPreliminary results were published in The New England Journal of Medicine.Medtronic stated,AnAllSafety and effectiveness results are sustainable for 18 months.。- Antitachycardia Pacing (ATP) in 48 Episodes37 TimesAchieving Success (77%）. This is consistent with the success probability of intravenous ATP.
- Aurora EV-ICD Excels in terminating ventricular tachycardia/ventricular fibrillation (VT/VF),For discrete spontaneous episodes of symptoms, the success rate of electroshock reaches100%。
- Among 299 patients with successful implantation, 24 patients experienced82 TimesSpontaneousPatients with atrial arrhythmia episodes received appropriate treatment with ATP (38), shock only (34), or both simultaneously (10).Aurora EV-ICDThe incidence of major complications is low, and the success rate of appropriate treatment is high.
- Patient-Reported Quality of Life (QOL) Metrics and Patient Acceptance of the DeviceThe feedback results are all relatively positive.；Compared with patients with subcutaneous ICDs,TheyHigher overall acceptance of ICD。
Medtronic is gathering real-world performance and safety data for the Aurora EV-ICD in the Enlighten study, which involvesMore than 125 sites, recruiting at least 500 patients, and collect follow-up data throughout the entire lifecycle of the device.Aurora EV-ICD is aNon-Vascular ICD, which aims to treat dangerous rapid heart rhythms that may cause sudden cardiac arrest (SCA), while avoiding certain risks associated with traditional transvenous ICDs.
Aurora EV-ICD consists of a defibrillator and leads.Up to40 JoulesCurrent, and is equipped with sensing and pacing circuits designed for retrosternal treatment.The lead is ε-shaped, with 2 pacing/sensing electrodes and 2 defibrillation coil segments, which can be tied together to form an 8 cm overall defibrillation coil, providing 3 sensing and 3 pacing vectors.The expected service life is 11.7 years.。Aurora EV-ICD was obtained in August 2023.EU CE Certification, obtained in October of the same yearFDA Certification in the United States, which is the latest (as of 2024.10.21) technology for implantable defibrillators globally.Implantable Cardioverter Defibrillator (ICD) is the most effective treatment for preventing sudden cardiac death. Currently, there are two types of ICD systems used in clinical practice in China:Transvenous ICD Systems and Subcutaneous ICD Systems.
Traditional transvenous ICDs typically implant the pulse generator between the pectoralis major and pectoralis minor muscles, with leads entering the right ventricle of the heart via the subclavian vein to detect electrocardiographic signals and identify arrhythmias.
The pulse generator of the EV-ICD is implanted subcutaneously near the mid-axillary line, with the defibrillation lead placed below the sternum and outside the heart and veins.Minimizes certain complications associated with transvenous leads, such as vascular injury and vascular occlusion (vein narrowing, blockage, or compression).In addition to the change in the product implantation site,Medtronic has also fully considered patients' user experience and financial burden in product design.。- Full functionality, broader treatment scope
Patients can have the device implanted through a dedicated surgical implantation tool, thereby obtainingDefibrillation, Anti-Tachycardia Pacing (ATP), and Backup Pacing TherapyMultiple functions.- 40 Joules of Energy for Effective Shock
EV-ICD can deliver 40 joules of defibrillation energy in a device the size of a transvenous ICD (33 cc).Deliver life-saving shocks to patients。- 11.7 Years Ultra-Long Lifespan, Reducing Surgical Volume
EV-ICD Expected Lifespan: 11.7 Years, which can reduce the number of device replacements a patient needs in their lifetime and lower treatment costs.- Unique technology, more comfortable implant experience
Medtronic's exclusive PhysioCurve™ designImprove Patient Comfort and Implant Acceptance。- Exclusive Algorithm to Reduce Inappropriate Shock Therapy
Patients treated with commercially available Aurora devices will also benefit from Smart Sense, a proprietary algorithm designed to reduce inappropriate shocks and prevent inappropriate therapy caused by P-wave oversensing.Reduced inappropriate detection rate caused by P-wave oversensing by 57%.。Distinguished Professor of CardiologyDr. Bradley KnightOnce stated: Aurora EV-ICD is a significant step forward in implantable defibrillator technology, enabling us to further advance safe and effective ICD technology.# China's First Clinical ApplicationOn May 30, 2024, under the leadership of Professor Tang Baopeng, Vice President of the First Affiliated Hospital of Xinjiang Medical University, members of the Cardiac Pacing and Electrophysiology Department team, Professor Li Yaodong and Doctor Jiasuoer Shaokreti, collaborated with Professor Huo Qiang, Director of the Cardiac Surgery Department.The First Case of Extravascular Implantable Cardioverter Defibrillator (Aurora EV-ICD™) Implantation in China was Successfully Performed at Ruijin Hainan Hospital in Boao, Hainan.Related Reading:Landed in China! Medtronic's World's First New Defibrillator
The surgical team of the First Affiliated Hospital of Xinjiang Medical University conducted a thorough and detailed preoperative assessment and screening of the patient. They also held multiple rounds of case discussions with Professor Ian Crozier from Christchurch Hospital in New Zealand, who has the most extensive global experience in EV-ICD implantation.The patient for this implantation was selected from among 14 patients with ICD indications.Aurora EV-ICD Intraoperative Testing and Postoperative Imaging# Product Market OverviewWith the acceleration of life pace and the increase of life pressure, cardiovascular diseases have become the number one killer of human health. Cases of sudden cardiac death (SCD) mainly caused by malignant arrhythmia are also showing a trend of becoming younger.Represented by implantable cardioverter defibrillators (ICD) and pacemakers, cardiac rhythm management (CRM) products have enormous market potential in China for the prevention of sudden cardiac death (SCD).。Sudden Cardiac Death (SCD) is one of the most common causes of death in cardiovascular diseases.Approximately 544,000 people in China suffer from sudden cardiac death each year.。The main causes of sudden cardiac death include arrhythmias (such as ventricular tachycardia or ventricular fibrillation), coronary heart disease, myocardial infarction, cardiomyopathy, hereditary heart disease, etc.Sudden cardiac death, due to its sudden onset and critical condition, mostly occurs outside hospitals, resulting in an extremely low success rate of rescue.Proportion of Survivors in ChinaOnly 1-2%。Implantable Cardioverter Defibrillator (ICD) has high technical barriers, complex system integration, and extremely high requirements for timeliness, effectiveness, and safety, while also providing pacing functionality akin to pacemakers.Currently at the forefront of CRM research,被誉为“The Jewel in the Crown of Cardiac General Instruments”. Clinical trials have proven,The efficacy of ICD implantation far exceeds that of taking anti-arrhythmia medications.. Therefore, in the relevant guidelines or expert consensus in the United States/Europe/China, allListing ICD as the "Gold Standard" for Treating SCD。The global implantable cardioverter defibrillator (ICD) market has shown a steady growth trend in recent years.According to relevant market research reports,The global market size reached several billion US dollars in 2022 and is expected to reach an even higher market size by 2028., with a compound annual growth rate (CAGR) remaining in the single-digit percentage range.In terms of regional distribution,The North American market accounts for a larger market share due to its mature medical infrastructure and higher healthcare expenditure.The Asia-Pacific region is expected to become the fastest-growing market due to its rapidly increasing healthcare demands and market potential.European MarketAlsoOccupying an important position, especially in advanced countries in the treatment of heart disease such as Germany, the United Kingdom, France, and Italy.As the most important细分板块 of CRM, the复合增长率 of China's ICD market in the past five years has been close to 20% and is expected toAchieve a compound annual growth rate of 25% in the next 10 years，Reach a market size of 2.96 billion by 2030. Behind this high growth rate isChina's ICD industry is still in the early cultivation stage, and the blue ocean market is clearly visible.。Major Players in the Global ICD MarketIncludingMedtronic, Boston Scientific, Biotronik, Abbott (after acquiring St. Jude Medical)Companies like Medtronic, plc. These companies have strong competitiveness in technological innovation, product quality, and global distribution networks.Currently IImport approved in ChinaICD ProductsA total of 13 models, and no domestically produced ICD products have been approved for marketing in China.。
Partially Approved Imported ICD Products
ICD, as a high-voltage product, requires R&D to overcome multiple high-difficulty technologies, such asHigh-efficiency high-voltage charge-discharge module, drug delivery system through wires, programmable UI design, perception recognition algorithmetc. Currently, Medtronic has launched the extravascular implantable cardioverter defibrillator (EV-ICD), marking a significant step in the development of safe and effective ICD technology. Prior to this, Boston Scientific had introduced the groundbreaking fully subcutaneous implantable cardioverter defibrillator.Subcutaneous Implantable Cardioverter Defibrillator (S-ICD), which also does not come into contact with the heart and blood vessels.The representative manufacturer in China's ICD field isMedtronic Heart Rhythm MedicalAndMedtronic。Created by Leading Heart Rhythm Management Medical Devices (Shanghai) Co., Ltd. in 2014, the company currently has three pacemaker products – Rega, Trefle, and Orchidee – that have obtained NMPA registration certificates. Meanwhile, its parent company, MicroPort, acquired LivaNova’s full CRM product line in 2017.Platinium™ ICD Products Gain Positive Feedback in Overseas Markets and Enter China as Imports。Medtronic was founded in 2017.The clinical trial of the self-developed implantable cardioverter defibrillator (Anbo® ICD) has successfully completed the enrollment of 75 patients.Ambo® ICD is expected to become the first domestically produced ICD to be launched in China., striving to achieve a comprehensive breakthrough in another "chokepoint" technology for domestically produced high-end medical devices, with an expected market launch in 2026. This device can prevent sudden cardiac arrest, reduce the burden on health insurance and patients, and is more aligned with the needs of Asian populations.It can be foreseen that, with the introduction of concepts like medical digitization and informatization, against the backdrop of China's current market being highly monopolized by imported manufacturers,Domestic manufacturers are also ushering in a golden period of development to fill the gap in domestic production and achieve import substitution.。
