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, The Galien Foundation announced2024 Prix Galien USA AwardsThe Nomination ListThe list covers three main categories:"Best Biotechnology Product," "Best Drug," and "Best Rare Product"。The Galien Award was established in 1970 by Roland Mehl to honor Galen, the father of medical science and modern pharmacology. The Galien Award aims to recognize outstanding scientific innovations made to improve human health and promote the development of pharmaceuticals and pharmacy, and is acclaimed as"The Nobel Prize of the Pharmaceutical Industry"。All nominated products mustApproved by the U.S. Food and Drug Administration (FDA) within the past five years, andDemonstrates great potential in improving human health。Among the 29 most innovative medical devices this year, 9 of which are cardiovascular system products.。
In July 2023, the U.S. FDA approvedAbbottGlobalTruly implant devices in the right atrium and right ventricle respectivelyOfDual-chamber Leadless Pacing System——AVEIR™ DR Dual-Chamber Leadless Pacemaker System.In June 2024, the system received the CE mark.AVEIR™ DR Dual-Chamber Leadless Pacemaker System forTreatment of Bradycardia. After being implanted into the heart through minimally invasive surgery, via Abbott's uniquei2i™ (implant-to-implant) High-Frequency Communication TechnologyAchieve interconnection and communication between atrial and ventricular devices, truly realizing synchronous dual-chamber wireless pacing.。AVEIR™ DR isRecyclableThe dual-chamber leadless pacemaker can be retrieved on demand whenever necessary or when the battery is depleted, flexibly meeting the treatment needs of patients at different stages.Aveir DR is only one-tenth the size of a traditional pacemaker.，Moreover, the battery current used by this pacemaker is lower than that used for inductive, radiofrequency, or Bluetooth communication, as well as conductive communication.More energy-efficient。
April 2020,AbbottThe First Transcatheter Tricuspid Valve Repair System TriClipObtained the European CE Mark. Received FDA approval in April 2024.Indicated for the treatment of tricuspid regurgitation (TR) or tricuspid valve leakage。The TriClip system was developed by Abbott based on another best-selling cardiac repair device, the MitraClip.Available in four sizes of chucks, suitable for different types of patients.The TriClip system is delivered through the leg veins.Can repair the tricuspid valve and help blood flow in the correct direction, without the need for open-heart surgery.The TriClip system utilizes the same clipping technology as the MitraClip system., clinicians can fix a portion of each valve in the patient's heart together and customize the surgical procedure according to each patient's unique valve.In addition,Abbott has also specifically designed for thisDifferentiated Delivery System for Tricuspid Valve Implantation, allowing the surgeon to grasp individually before fixation.During the surgery, the doctor will implant the TriClip system into the patient's heart through the femoral vein, using an edge-to-edge technique to grasp a portion of the tricuspid valve leaflets together, reducing blood regurgitation.The TriClip system is delivered through the leg veins.Can repair the tricuspid valve and help blood flow in the correct direction, without the need for open-heart surgery.The TriClip system is delivered through a vein in the leg to repair the tricuspid valve and help blood flow in the correct direction, without the need for open-heart surgery.
# 03 ELUVIA Drug-Eluting Vascular StentBoston ScientificTheELUVIA Drug-Eluting Vascular Stent YesThe World's First Polymer-Coated Peripheral Artery Drug-Eluting Stent,Applicable to lower extremity arterial occlusive disease.
ELUVIA It is a drug-eluting stent with paclitaxel sustained-release technology, which is revolutionary.365-Day Sustained-Release Technology, fully covering the restenosis process; delivering most of the drug to the tissue through a polymer, minimizing downstream particles,Achieve the optimal vascular recanalization rate with the lowest drug dosage (0.167ug/mm²) currently available on the market.。Approved for marketing by the FDA in September 2018 and by the NMPA in July 2020.。
The clinical value of the ELUVIA Drug-Eluting Vascular Stent has been demonstrated in multiple clinical studies, with the IMPERIAL study showing,The patency rate was as high as 92.1% at 1 year post-operation, and the target lesion revascularization (TLR) event was only 4.5%., whose clinical manifestations and safety are far superior to those of similar products in the control group.# 04 Evoque Tricuspid Valve Replacement SystemEdwards LifesciencesTheEVOQUE Tricuspid valve replacement system isThe First to Receive FDA Approval (February 2024)Used forTreatment of Tricuspid RegurgitationThe transcatheter treatment method, the anchoring method of the EVOQUE valve isAnchoring the valve by grasping the native leaflets and annulus, composed of a self-expanding nitinol stent, bovine pericardial leaflets, a fabric skirt, and a leaflet retrieval device.EVOQUE Valve Uses Minimally Invasive Delivery System (Catheter)Through the femoral vein into the heart,Allows replacement of the patient’s native tricuspid valve through minimally invasive surgery, eliminating the need for traditional open-heart surgery; available in three sizes: 44mm, 48mm, and 52mm, all implanted via a low-profile 28F femoral artery delivery system.The single-arm, prospective, global multicenter study of the EVOQUE system demonstratedGood safety and efficacy as well as significant improvement in quality of life. The main findings includeHigh survival rate (90.1%)And non-heart failure hospitalization rate (88.4%);Significant and sustained reduction in tricuspid regurgitation (97.6%); Cardiac function and quality of life significantly improved (93% of patients were in NYHA Class I or II, compared to 26% at baseline, and the KCCQ score increased by 26 points from baseline).# 05 SAPIEN 3 and ALTERRAIn 2014,Edwards LifesciencesIn the TAVR fieldSAPIEN 3 ValveObtained CE certification in Europe and received market approval in Japan and the United States in 2016 and 2017, respectively.In December 2021, Edwards Lifesciences Corporation announced its product SAPIEN 3 and ALTERRA Gain FDA Approval for Combined Use, used to treat patients with severe pulmonary regurgitation. The approval of the combined use of SAPIEN 3 and ALTERRA expands the transcatheter treatment options for patients with congenital pulmonary valve disease.ALTERRA refines the size and shape variations of the right ventricular outflow tract, providing a stable landing zone for the SAPIEN 3 valve.。
SAPIEN 3 includes a tri-leaflet bovine pericardial tissue valve, with a balloon-expandable, radiopaque, cobalt-chromium alloy frame and inner and outer polyethylene terephthalate fabric.The inflow of the valve is covered by an external polyethylene terephthalate cuff.Can enhance perivalvular sealing. Cobalt-chromium alloy stent and wide strut angleProvides anti-fatigue and high radial strength。ALTERRA is aCovered Stent Graft，Used in TPVR procedures as a SAPIEN 3 holderALTERRA consists of a self-expanding, radiopaque nitinol stent and polyethylene terephthalate (PET) fabric.And has designated inflow and outflow endsThe inflow portion can be identified by the presence of two triangular lobes, which are connected to the delivery system and the circumferential fabric of all units. The PET fabric is sutured to the inner surface of the stent, forming a seal at the inflow portion.# 06 SAPIEN 3 Ultra RESILIASeptember 2022,Edwards LifesciencesAnnouncement of Sapien 3 Ultra Resilia Transcatheter Balloon-Expandable Aortic ValveObtained FDA Approval, this isThe World's FirstBalloon-Expandable Transcatheter Aortic Valve. This valve willResilia Tissue Processing TechnologyLeading in the industrySapien 3 Ultra Transcatheter Aortic Valve Combination。
Resilia Tissue Processing Technology:Technology for Treating Bovine Pericardial Tissue with Anti-calcification Process, adding significant value to the Sapien 3 Ultra platform, including enhanced calcium ion blocking properties and a user-friendly dry tissue packaging.The Resilia tissue processing technology has been proven to show no structural valve deterioration within 5 years and has the potential to extend the durability of the valve.
Exclusive Dry Valve Preservation Technology:Further simplified the preoperative operation steps and reduced the risk of aldehyde residue.
Metal Stent Frame:The valve utilizes a cobalt-chromium alloy as the metal frame, bovine pericardial tissue as the leaflets, and incorporates a design with inner and outer skirts made of polyethylene terephthalate (PET) material to reduce paravalvular regurgitation and ensure long-term healing.
Expand the Applicable Patient Population:29mm Valve Extends Perivalvular Leak (PVL) Outer Skirt Technology to Patients with Larger Annuli.
# 07 DETOUR System
EndologixDeveloped by the companyDETOUR SystemProvides a new alternative to open bypass surgery for patients with peripheral artery disease (PAD).World's First Fully Percutaneous Transmural Artery Bypass (PTAB) Therapy. This is the first percutaneous procedure that can effectively bypass long femoral-iliac lesions. The system has received Breakthrough Device Designation from the FDA.Received FDA approval via the PMA pathway in 2023。
The DETOUR System consists of the ENDOCROSS Device and the TORUS Stent Graft.ENDOCROSS DeviceIt is a spring-loaded dual guidewire delivery tool that uses a 0.025" nitinol needle to create an arteriovenous-arterial access.TORUS Stent GraftCan enter the femoral vein from the popliteal artery, or enter the superficial femoral artery from the femoral vein. The TORUS stent graft is designed with radial strength to resist external forces at the anastomosis site.
System throughFluoroscopic Navigation(Using X-rays to display the position of catheters and instruments inside blood vessels in real time, to help doctors accurately locate and operate), created aFemoral-popliteal bypass through the femoral vein, allowing blood to flow smoothly from the superficial femoral artery (SFA) to the popliteal artery.Impulse DynamicsIs the pioneer in the development of Cardiac Contractility Modulation (CCM) technology, and its Optimizer smart device isThe First and OnlyFor patients with stage III heart failure and FDA-approvedsystem. The Optimizer smart device was awarded the "Breakthrough Device Designation" by the U.S. FDA in 2015, and in March 2019,FDA Approves Optimizer SystemUsed to treat patients with heart failure with reduced ejection fraction, it is the only CCM device approved by the FDA in the United States.
The system is currentlyLaunched in 44 countries/regions, including the United States, the European Union, China, Brazil, and India.In 2021, the new generation of cardiac contractility modulatorCCM Optimizer Smart Receives NMPA Approval for Marketing.
Optimizer Smart System includes a device about the size of a pacemaker.Implantable Stimulator DeviceAnd aExternal Charging StationThe doctor will implant the stimulation device along with the leads into the right ventricular septum of the patient's heart while the patient is under mild anesthesia; after implantation, the doctor will customize the program for the patient and activate the device.Optimizer Smart Electric pulses will be sent daily to stimulate the heart muscle for a total of 5 hours.. Patients need to charge the device once a week using an external charger. Optimizer SmartThe service life can reach up to 15 years. The implantation process does not require open-heart surgery.，And most patients can go home immediately after the implantation.Common pacemakers and defibrillators restore the heart's normal rhythm by regulating its rate.The particularity of the Optimizer device lies inMainly regulates the intensity of myocardial contractionIt can deliver non-excitatory electrical stimulation to the myocardium, thereby triggering various biochemical and neurohormonal changes in the myocardium. Through this method, the contractility of the myocardium is enhanced without a corresponding increase in oxygen consumption, ultimately achieving the goal of making the heart work more efficiently.MedtronicTheSymplicity Spyral Multi-Electrode Renal Denervation (RDN) System Received FDA Approval in November 2023, BecomingThe Second RDN Product Approved by the FDA。Symplicity Spyral is aTranscatheter Radiofrequency Ablation DeviceBy delivering radiofrequency energy through a radiofrequency ablation catheter to the overactive nerves in the renal arteries for ablation, it will help patients with hypertension lower their blood pressure and reduce reliance on antihypertensive medications.
▲Symplicity Spyral Multi-Electrode Renal Denervation Catheter (SourceFromCompany Official Website）Symplicity Spyral byMulti-electrode Ablation Catheter（Symplicity Spyral) andRadiofrequency Generator（Symplicity G3).Symplicity Spyral CatheterThere are four electrodes distributed at the head of the spiral catheter, simultaneously covering four quadrants.Capable of achieving 360° ablation, can treat renal branches,Maximize Complete Denervation. This catheter is suitable for blood vessels ranging from 3-8mm, offering a wide range of treatment options. It is4F catheter, compatible with 6F guiding catheter and 0.014" guidewire;The non-occlusive design allows for continuous blood flow, naturally protecting the vessel wall.Symplicity G3 Equipped with Medtronic's unique algorithm, capable ofDelivers precisely controlled RF energy. It canIndependently assess the temperature and impedance feedback of each electrode; Respond according to the monitoring data algorithm, automatically adjust the power to ensure the delivery of appropriate and safe energy. MoreoverRadiofrequency energy preferentially heats the adipose tissue where renal nerves are located andAvoid Non-Target Structures；Can achieve complete denervation of the entire renal anatomy, including distal branches.
