MitraClip Transcatheter Mitral Valve Repair | Abbott
CARDIOVASCULAR
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MitraClip

Life-Changing TEER Therapy for Select Patients with Mitral Regurgitation

MitraClip™ is the world’s first mitral transcatheter edge-to-edge repair (TEER) therapy -- also referred to as TMVr (transcatheter mitral valve repair) -- that delivers a minimally invasive treatment option for select patients with primary or secondary mitral regurgitation (MR) who would otherwise go untreated.1,2 With more than 18 years of clinical experience and over 150,000 patients treated worldwide, MitraClip™ is a well-established procedure with the highest-reported MR reduction, proven safety and survival, and durable clinical outcomes.3,9

Learn about the clinical performance of the MitraClip™ TEER System.

Tailored. Optimized. Proven.

At Abbott, we continue to innovate with the fourth-generation MitraClip™ device. MitraClip™ G4 features several enhancements that offer physicians more treatment options that can be tailored to a patients' unique mitral valve anatomy.
 

Expanded Range of Clip Sizes

A total of 4 clip sizes—now including clips with wider grasping area—gives physicians the ability to choose a clip size based on each patient’s mitral valve anatomy.1,4-5

Controlled Gripper Actuation (CGA)

With more options to confirm and optimize leaflet grasping, CGA allows physicians to grasp leaflets simultaneously or independently.1,4

Predictable Procedure Experience5-6

Precision and stability from a delivery system specifically designed for the mitral valve facilitates Left Atrial Pressure (LAP) monitoring.4

Both AHA/ACC/HFSA and the ACC/AHA Guidelines Favor Intervention

Transcatheter edge-to-edge repair (TEER) therapy is recommended by the 2022 AHA/ACC/HFSA7 and the 2020 ACC/AHA Guideline8 for select primary and secondary* MR patients. Determining the severity of MR is an important factor in the management of the condition. The guidelines support aggressive monitoring and early action, with the goal of preventing complications due to left ventricular volume overload.7


*Secondary MR patients despite optimal guideline-directed management and therapy (GDMT).

ACC/AHA Treatment Guidelines

Learn more about MitraClip™ TEER by visiting the Abbott Structural Heart website

Ordering Information

MitraClip™ G4 System

Product Code Description Piece Count
MCG40100 MitraClip G4 System 1
CDS0701-NT MitraClip G4 NT Clip Delivery System 1
CDS0701-NTW MitraClip G4 NTW Clip Delivery System 1
CDS0701-XT MitraClip G4 XT Clip Delivery System 1
CDS0701-XTW MitraClip G4 XTW Clip Delivery System 1
SGC0701 MitraClip G4 Steerable Guide Catheter 1


Required Accessories

Product Code Description Piece Count
SZR01ST Stabilizer 1
LFT01ST Lift 1
PLT01ST Support Plate 1

References

  1. MitraClip G4 Instructions for Use.
  2. Lim DS, et al. Improved functional status and quality of life in prohibitive surgical risk patients with degenerative mitral regurgitation after the transcatheter mitral valve repair. J Am Coll Cardiol. 2014;64(2):182-192.
  3. Data on file at Abbott.
  4. Tests performed by and data on file at Abbott.
  5. Rottbauer W. D. Contemporary Clinical Outcomes with MitraClip™ (NTR/XTR) System: Core-lab Echo Results from +1000 Patient the Global EXPAND Study. Data presented at PCR 2020.
  6. Maisano F. Clip Selection Strategy and Outcomes with MitraClip™ (NTR/XTR): Evidence-Based Recommendations from the Global EXPAND Study. Data presented at PCR 2020.
  7. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association. Joint Committee on Clinical Practice Guidelines.” J Am Coll Cardiol. Apr 01, 2022. Epublished DOI: 10.1016/j.jacc.2021.12.012
  8. Otto C, et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2021;77(4):e25-e127.
  9. Rodriguez E. Contemporary Outcomes with the MitraClip™ G4 System: Preliminary Results based on the EXPAND G4 Study. Data presented at TCT 2021

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Important Safety Information

MITRACLIP™ CLIP DELIVERY SYSTEM

Indications for Use

  • The MitraClipTM G4 System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.
  • The MitraClipTM G4 System, when used with maximally tolerated guideline-directed medical therapy (GDMT), is indicated for the treatment of symptomatic, moderate-to-severe or severe secondary (or functional) mitral regurgitation (MR; MR ≥ Grade III per American Society of Echocardiography criteria) in patients with a left ventricular ejection fraction (LVEF) ≥ 20% and ≤ 50%, and a left ventricular end systolic dimension (LVESD) ≤ 70 mm whose symptoms and MR severity persist despite maximally tolerated GDMT as determined by a multidisciplinary heart team experienced in the evaluation and treatment of heart failure and mitral valve disease.

Contraindications

The MitraClip G4 System is contraindicated in patients with the following conditions: Patients who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or post procedural anti-platelet regime; Patients with known hypersensitivity to clip components (nickel / titanium, cobalt, chromium, polyester), or with contrast sensitivity; Active endocarditis of the mitral valve; Rheumatic mitral valve disease; Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus

Potential Complications and Adverse Events

The following ANTICIPATED EVENTS have been identified as possible complications of the MitraClip G4 procedure: Allergic reactions or hypersensitivity to latex, contrast agent, anaesthesia, device materials (nickel / titanium, cobalt, chromium, polyester), and drug reactions to anticoagulation, or antiplatelet drugs, Vascular access complications which may require transfusion or vessel repair including: wound dehiscence, catheter site reactions, Bleeding (including ecchymosis, oozing, hematoma, hemorrhage, retroperitoneal hemorrhage), Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation / rupture, vascular occlusion, Emboli (air thrombotic material, implant, device component); Peripheral Nerve Injury; Lymphatic complications; Pericardial complications which may require additional intervention, including: Pericardial effuse on, Cardiac tamponade, Pericarditis; Cardiac complications which may require additional interventions or emergency cardiac surgery, including: Cardiac perforation, Atrial septal defect; Mitral valve complications, which may complicate or prevent later surgical repair, including: Chordal entanglement / rupture, Single Leaflet Device Attachment (SLDA), Thrombosis, Dislodgement of previously implanted devices, Tissue damage, Mitral valve stenosis, Persistent or residual mitral regurgitation, Endocarditis; Cardiac arrhythmias (including conduction disorders, atrial arrhythmias, ventricular arrhythmias); Cardiac ischemic conditions (including myocardial infarction, myocardial ischemia, and unstable / stable angina); Venous thromboembolism (including deep vein thrombosis, pulmonary embolism, post procedure pulmonary embolism); Stroke / Cerebrovascular accident (CVA) and Transient Ischemic Attack (TIA); System organ failure: Cardio-respiratory arrest, Worsening heart failure, Pulmonary congestion, Respiratory dysfunction / failure / atelectasis, Renal insufficiency or failure, Shock (including cardiogenic and anaphylactic); Blood cell disorders (including coagulopathy, hemolysis, and Heparin Induced Thrombocytopenia (HIT)); Hypotension / hypertension; Infection including: Urinary Tract Infection (UTI), Pneumonia, Septicemia; Nausea / vomiting; Chest pain; Dyspnea; Edema; Fever or hyperthermia; Pain; Death; Fluoroscopy, Transesophageal echocardiogram (TEE) and Transthoracic echocardiogram (TTE) -related complications: Skin injury or tissue changes due to exposure to ionizing radiation, Esophageal irritation; Esophageal perforation, Gastrointestinal bleeding

Important Safety Information

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