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,World's Smallest Interventional Cardiac PumpElevate DeveloperMagenta Medical AnnouncementComplete a new round$105 million financing (equivalent to 760 million yuan)，ByGlobal healthcare investment firm Novo Holdings leads the investment, with Viking Global Investors, RA Capital Management, OrbiMed, New Enterprise Associates (NEA), JVC Investment Partners, and ALIVE-Israel HealthTech Fund following suit.This round of financing is mainly used to advance itsClinical Research on Minimally Invasive Cardiac Pumps, and ensure FDA approval for the Elevate system.Patients Undergoing High-Risk Percutaneous Coronary Intervention (HR-PCI)。According to data from the U.S. market research firm Grand View Research, the global ventricular assist device market size was $1.8 billion in 2020.It is expected to grow at a compound annual growth rate of 17.6% from 2021 to 2028.. Among themLeft Ventricular Assist Device (LVAD)The niche market dominated the VAD market, accounting for the largest share of 80.5%.。It is worth noting that, LAVDStar ProductThe manufacturer of ImpellaAbiomed was one of the B-round investors in Magenta Medical.。Facing the rapidly growing market in the future, as well as the remarkable growth point of LVAD, what unique technological innovations does Elevate have to secure a position in the future LVAD field?# Product Application ProspectsMechanical Circulatory Support (MCS) is a field in interventional cardiologyOne of the fastest-growing markets，After nearly 50 years of development,Mechanical Circulatory Support(mechanical circulatory support, MCS) technology is becoming increasingly mature and has currently becomeOne of the effective alternative treatments for end-stage heart failure。MCS is an artificial device that replaces or assists cardiac function, provides blood perfusion to the extracardiac area, improves the body's hypoxic state, and promotes organ function recovery.It can provide short-term and medium- to long-term circulatory support, helping patients through the critical period of illness, bridging to heart transplantation or long-term circulatory support treatment.Due to the continuous increase in the prevalence of severe end-stage heart failure, poor efficacy of drug treatments, insufficient donors for heart transplantation, and the significant reduction in quality of life caused by limited cardiac function, the application of ventricular assist devices has become predominant.MCS is becoming an important alternative treatment for patients with end-stage refractory heart failure.。Elevate aims to meet these needs and overcome the significant limitations of existing temporary MCS devices. With these potential advantages, Magenta Medical'sElevate System Granted Breakthrough Device Designation by U.S. FDA for Two Clinical Indications: High-risk percutaneous coronary intervention (HR-PCI) and cardiogenic shock (CS).
Magenta completed an early feasibility study in the U.S. for the HR-PCI indication in 2023.Dr. Perwaiz Meraj of North Shore University Hospital presented the research findings at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) conference held in San Francisco. Based on this study,Magenta is currently preparing to launch a pivotal study in the United States.。
# Self-expanding interventional cardiac pumpMagenta Elevate Is aSelf-expanding interventional cardiac pump, used to provide temporary mechanical circulatory support for the left ventricle (LV) in high-risk percutaneous coronary intervention (HR-PCI) and cardiogenic shock (CS) inpatients. Elevate achieves this throughReduce the pressure and volume of the left ventricle, and alleviate cardiac load.Thereby reducing ventricular wall stress, mechanical work, and myocardial oxygen consumption.Magenta Medical's proprietary technology has achievedMiniaturization of Percutaneous Left Ventricular Assist Devices, allowing it to be compatible with a 9Fr delivery system,It is the smallest of such devices.。Self-expanding impeller and pump head design, composed of a thin memory-shaped metal frame and a soft elastic material forming the blade body.When inCompression ProcessWhen an axial force is applied, the impeller stretches and its diameter decreases; when necessaryExpansion and Re-expansionDuring this period, the impeller, relieved of axial force, can return to its original working position.The size ratio of the self-expanding impeller before and after compression is as high as 3.5:1, which is a very large expansion ratio, thusAchieving Small Size, Large Flow。In view of this,Magenta Elevate Both in terms of size and blood flow pumping capacity, it surpasses the Impella ECP.(Products of Abiomed, a company acquired by Johnson & Johnson).- Through a 10Fr introducer sheath,Reach the left ventricle under the guidance of a 0.018" guidewireOnce placed in the left ventricle, the self-expanding pump head detaches from the sheath, expanding from 9Fr to 30Fr.
- Can be delivered to the target area through an 8Fr delivery system.。Once placed inside the heart, the pump's speed can be adjusted to provide over 5 at physiological blood pressure.L/min The average blood flow (relative to the total blood volume pumped by an adult in one cycle). Its peak flow even exceeds 7L/min。
- During the placement process, Elevate utilized standard catheter insertion techniques and equipment, which not onlyImproved the ease of use and safety of the operation, while also simplifying the process of vascular access closure.。
VC Partner at Novo Holdings USEric Snyder Said: "Magenta's technology is at the forefront of innovation in the MCS field.，has the potential to significantly improve treatment outcomes for patients with severe cardiovascular diseases. We support the Magenta team in providing higher quality care to more patients in need of mechanical circulatory support."CEO of Magenta MedicalDavid Israel Ph.D.Said: "We are very pleased to bring these outstanding medical technology investors into our mission to revolutionize the MCS field. We are fortunate to have assembled a world-class team of investors alongside our existing partners, who are able toLeading Magenta to Regulatory Approval and Commercial Growth。”# Interventional Cardiac Pump Competitor OverviewPercutaneous Ventricular Assist Devices (pVAD) are medical devices used for cardiac support, particularly suitable for patients with acute heart failure and high-risk percutaneous coronary intervention (PCI).Impella Series (Abiomed）：The Impella heart pump, produced by Abiomed, is a globally recognized interventional heart pump product, featuring several pump models with different flow levels, such as the Impella CP, Impella 2.5, Impella 5.0, and Impella ECP.The Impella series is renowned for its high flow, low shear stress, and adaptive regulation features.。
November 2022,Johnson & Johnson Announces $16.6 Billion Acquisition of Abiomed, Leader in Artificial Heart TechnologyIn 2023, contributed revenue of $1.306 billion.
This acquisition was announced by Johnson & JohnsonDivestment of Consumer Health BusinessSinceFirst StrokeLarge acquisitions, also one of the largest acquisition projects in Johnson & Johnson's history. It is this incremental revenue that has enabled Johnson & Johnson Medical to compete with Medtronic in overall revenue.HeartMate PHP（Abbott）：HeartMate PHP is a percutaneous cardiac pump that can be inserted through the femoral artery to provide temporary mechanical circulatory support for the left ventricle. However, this product was discontinued in 2021.
Aortix™ pLVAD：Procyrion'sAortix is a percutaneous arterial pump that can be inserted through the femoral artery to provide cardiac support within the aorta and is currently undergoing clinical trials.Aortix is very small, with a diameter of only 6 mm and a length of 6.5 cm.Aortix is placed in the descending aorta via percutaneous catheter intervention for up to 7 days, reducing cardiac load, allowing the heart to rest, and increasing renal blood supply.
February 2024,Procyrion Announces $57.7 Million Series E Financing to Support Ongoing DRAIN-HF Pivotal IDE TrialEvaluate the safety and efficacy of Aortix in patients with acute decompensated heart failure (ADHF).In addition, the funds will support internal programs aimed at enhancing product manufacturability and preparing for commercialization.
Supira pLVAD：Developed by Supira Medical. This is a new type of interventional cardiac pump designed to be inserted through the radial artery, providing high flow and low shear stress cardiac support.
By the end of 2023, the company completed a $40 million Series D financing round, andNext-Generation Percutaneous Ventricular Assist Device（pVAD）Supira System Receives U.S. FDA Clearance Breakthrough Device DesignationFixed。
NyokAssist™ (Magenta Medical):Magenta MedicalNyokAssist™With the world's smallest interventional size of 9Fr (3mm), it can minimize bleeding., reducing the occurrence of perioperative and postoperative vascular complications, achieving higher flow while operating at lower speeds, and minimizing the damage to blood cells caused by the high-speed rotation of the impeller.
In February 2024, the minimally invasive interventional artificial heart NyokAssist™ received the U.S. FDA "Breakthrough Device" designation and the National Medical Products Administration's innovative medical device approval within a span of six months.Becoming the world's only interventional artificial heart to simultaneously obtain "dual innovation" certifications in both China and the United States.
Working Principle:
Rapid expansion and release after entering the body
Foldable impeller design enables greater flow at lower speeds.
Currently, the product has completed the development processes such as type inspection and animal trials, and is about to commence clinical trials.
# CloseInMagenta Elevate
Magenta Medical Magenta Medical, Ltd. is an innovative medical technology company born and bred in Israel. Established in 2012, its two founders, Yosi Tuval and Ehud Schwammenthal, are both from Israel and currently serve as the company's CTO and CMO, respectively.The company is committed toDevelopment of Miniature Interventional Cardiac Pumps, its developed micro blood pump technology aims to provide minimally invasive medical support for heart disease patients. This technology is mainly used forAddressing Acute Cardiac Dysfunction Effectively Prevents Hypotension-Induced Critical Organ Hypoperfusion。Currently, Magenta Medical, Ltd.Elevate Percutaneous Left Ventricular Assist Device (pLVAD) is Undergoing Clinical TrialsThe device will be evaluated for two major indications: patients undergoing high-risk percutaneous coronary intervention (HR-PCI) and patients with cardiogenic shock. Through these clinical trials, Magenta Medical hopes to provide safer and more effective solutions for the treatment of heart disease.
