Source of the article:Heart NotCome;Editor: Yang Liurong
Reprint Requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.Recently,FDA Medical Device Advisory Committee(Medical Devices Advisory Committee) Circulatory System Devices Panel13 votes in favor, 1 vote against, 0 abstentions, ConfirmAbbottTheTriClip™ Transcatheter Edge-to-Edge Repair (TEER) SystemThe Benefits of Treating Tricuspid Regurgitation (TR) Outweigh the Risks。
As TriClip Receives Overwhelming Support, ItsWill Receive FDA Approval for Market Launch in 2024. This is another major breakthrough in the field of structural heart disease following the FDA approval of Edward's EVOQUE.
The TriClip™ System Developed by AbbottYesWorld's First CE ApprovedTranscatheter Tricuspid Valve Repair Device，The panel's decision was based on clinical data from the TRILUMINATE™ pivotal trial and expert testimony.FDA Will Consider Expert Panel's Vote in Deciding Whether to Approve TriClip.
In the field of tricuspid valve repair, Abbott's biggest competitor remains Edwards' PASCAL Precision.PASCAL Precision received CE approval in 2022. It is a device capable ofUsed for both mitral regurgitation and tricuspid regurgitation simultaneouslyTreatment device.
Although TriClip can only treat tricuspid regurgitation, it benefits from the reputation积累 of Abbott's MitraClip in the industry (Used by more than 150,000 patients), which may enable TriClip to compete with PASCAL Precision in the tricuspid valve field.In the edge-to-edge repair field, Abbott has a first-mover advantage, but Edwards offers a more comprehensive solution., The competition between the two giants has gradually begun.
# TriClip System Receives FDA Panel Vote of Support
The FDA Medical Device Advisory Committee's Circulatory System Devices Panel voted 13 to 1 in support.The TriClip system has more benefits than drawbacks in treating tricuspid regurgitation.Safety：14 votesIn favor, 0 votes against;Effectiveness：12 votes in favor, 2 votes against;TriClip Shows Greater Benefits Than Risks in Treating Tricuspid Regurgitation：13 votes in favor, 1 vote against.
Abbott submitted TriClip to the FDA for premarket approval in March 2023.The company expects the FDA to make a decision on the submission this year.FDA to Consider Panel Vote in Final DecisionIf approved (the expert panel votes in favor, which is more likely),It will replace the recently FDA-approved Edwards Lifesciences'EVOQUETricuspid Valve，This isThe First Transcatheter Tricuspid Valve Replacement Product Approved by the FDA。EVOQUE is suitable for improving the health condition of patients with symptomatic severe tricuspid regurgitation.。According to Heart Future's understanding,Abbott calls TriClip a first-of-its-kind minimally invasive device。Analysts previously indicated that they expected TriClip to receive FDA approval for market release.The product received CE approval for marketing in 2021 and has been granted regulatory approval for marketing in more than 50 countries.More than 10,000 patients with tricuspid regurgitation have been treated with TriClip.The safety and effectiveness of TriClip have been widely recognized."Tricuspid regurgitation puts extra pressure on the heart and leads to other cardiovascular problems, significantly worsening the patient's quality of life.Treatment Options for Patients with Tricuspid Regurgitation Are Actually Limited. "Abbott StructuralSexual Heart Business"Chief Medical Officer and Vice President of the Department said."The TriClip system offers a much-needed alternative,It is safe and effective for people who need tricuspid valve repair but cannot withstand surgery.。“# About the TriClip System
The TriClip system is from Abbott.In another best-sellingCardiac Repair Device MitraClipDeveloped based onMitraClip helps treat mitral regurgitation, a condition where blood flows back through the valve with each heartbeat. Regurgitation is one of the most common valve diseases. After the MitraClip device is implanted in the patient, it can clamp the two leaflets of the heart in between, creating two smaller openings to prevent blood from flowing back.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 specifically designed for this purpose.Differentiated Delivery System for Tricuspid Valve Implantation, allowing the surgeon to grasp individually before fixation. During the surgery, the doctor willImplant the TriClip system into the patient's heart through the femoral vein., usingEdge-to-Edge TechnologyBring the parts of the tricuspid valve leaflets together to reduce blood regurgitation.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.
# Basis for FDA Panel's Decision
FDA Medical Device Advisory Committee Circulatory System Devices PanelThe voting results,Based on Clinical Data and Expert Testimony from the TRILUMINATE Pivotal TrialAbbott recently reported positive results from the TCT trial in October, includingSignificant improvement in patients' quality of life andTriClip SystemExcellent Safety。Abbott previously conducted evaluations at 21 medical centers in Europe and the United States.Safety and Efficacy of TriClip in Reducing Tricuspid RegurgitationTRILUMINATE Trial. The trial results showed,86% of patients had a reduction of at least 1 grade in tricuspid regurgitation severity, reaching the pre-specified efficacy endpoint.At 6 months of follow-up, 3 (4%) of 84 patients had serious adverse events,Achieve the pre-specified safety endpointAdhesions occurred in 5 (7%) of the 72 patients.No perioperative death, conversion to surgery, device embolization, myocardial infarction, or stroke occurred during the trial. The trial confirmed,TriClip System Can Safely and Effectively Reduce the Degree of Tricuspid Regurgitation in Patients, Six months after the surgery, patients can achieve significant clinical improvement.After reviewing the clinical data from the TRILUMINATE pivotal trial and hearing expert testimony,FDA Medical Device Advisory Committee Circulatory System Devices Panel,CorrectTriClip SystemVoted on the safety, efficacy, and risk/benefit profile.Regarding the question of whether there is sufficient data to support safety,The expert panel passed with a 14:0 vote.. In order to reasonably ensure effectiveness,The expert panel voted 12 to 2 in favor.。The last question regarding benefits and risks,The voting result was 13:1 in favor.。The co-principal investigator of the TRILUMINATE pivotal trial stated: "In the TRILUMINATE pivotal trial, we found that in patients who underwent tricuspid valve repair using the TriClip implant,90% of the severity of tricuspid regurgitation was significantly improved, the safety of the surgery was ensured, and the quality of life of these patients was improved continuously for one year.The TriClip system ushers in a new era of structural treatment for patients with severe tricuspid regurgitation.”# Analyst's Viewpoint
BTIG analysts Marie Thibault and Sam Eiber said that the favorable vote increased their confidence in "the coming months"FDA ApprovalTriClip System LaunchConfidenceThey pointed out that, after the meeting ended, the last two products reviewed by the same group took two to three months to gain approval. It is understood that these two products are renal denervation products from Recor Medical and Medtronic, respectively. Among them,Recor Medical's ProductsReceived favorable votes, while Medtronic's product did not receive favorable votes, but both systems were eventually approved for marketing by the FDA.。Analysts pointed out"Despite limited treatment options for patients with tricuspid regurgitation, thoseThe number of patients with tricuspid regurgitation is also smaller than the number of patients with mitral regurgitation.But due toTricuspid RegurgitationLimited treatment options，Management Still Bullish on Tricuspid Regurgitation Treatment Market。”Analyst said that the only person who insisted on the risk/benefit vote hoped to obtain more information or better define which patients would benefit the most. He said that he might vote in favor if the scope of the proposed usage instructions were narrower.FDA Panel Members BelieveThe early and sustained improvements (up to 12 months) with the TriClip system are an advantage.Most people also believe that Abbott can do more to identify which patients will benefit the most.Abbott/Abbott(New York Stock Exchange code: ABT)Founded in 1888, with its headquarters located in Chicago, USA. After a century of development, the company has now become a diversified Fortune 500 enterprise and is an international healthcare company. Abbott's businesses are divided intoPharmaceuticals, Nutritional Products, Diagnostics, Medical DevicesFour categories. Among themMedical DeviceFurther divided intoSubcategories such as heart rate management, electrophysiology, heart failure, vascular, structural heart, neuromodulation, and diabetes。According to Abbott's announcementThe Fourth Quarter Earnings Report and Full-Year Performance of Fiscal Year 2023 Show:
- Revenue in 2023 was $40.11 billion, a decrease of 8.1% year-on-year; revenue in the fourth quarter was US$10.24 billion, an increase of 1.5% year-on-year;
- 2023Annual net profit of $5.72 billion, a decrease of 17.5% year-on-year; net profit in the fourth quarter was US$1.59 billion, increasing by 54.2% year-on-year;
- Medical device business saw the most significant growth in 2023, with annual sales reaching $16.89 billion, representing a year-on-year increase of approximately 14%., among whichDiabetes care grows fastest (22.1%), followed by neuromodulation (15.5%), and then electrophysiology (13.9%);
- Organic sales growth (excluding COVID-19 testing-related sales) for the full year of fiscal 2024 is expected to be between 8.0% and 10.0%.
Overseas Cardiovascular Devices:
Artivion | Abbott | Shockwave Medical | HVR Cardio | Abiomed |CardiacSense | Lydus Medical | Volta Medical |Cardiac Dimensions | HeartBeam | MedtronicRadiant | MedtronicAcQCross | Acutus Medical | Boston Scientific | Cardiovascular Systems | CVRx | Biotronik | Edwards Lifesciences |Cordis
Products from Chinese cardiovascular companies:
Huamao Tech | Cardiovascular Medical | Biosensors | Venus Medtech | Lepu Medical | Lifetech Scientific | Minimally Invasive Medical | Bain Medical |
Global MedTech TOP100: 2023 Global MedTech TOP100
2023 Global MedTech Industry Contribution Award
2023 Global Medical Technology Innovation Award
2023 Global MedTech Rising Star Award
2023 Global Innovative Medical Device Award
Global Leading Medical Device Companies | Dynamic CollectionChina Medical Device Listed Companies | Dynamic CollectionMindray Medical|Nine An Medical |Weigao Co., Ltd.|DAAN Gene|Lepu Medical|Mingde Biotech |Shinva Medical|United Imaging Healthcare|Oriental Biotech|Yuwell Medical|Kehua Bio-engineering|Intco Medical|Saintway Biotech|Guo Ke Heng Tai|DAAN Gene|Ying Tai Medical
Editor-in-Chief | Zhao Qing Reviewed by | Yi He
