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MITRAL REGURGITATION
(MR) IS PREVALENT AND
GROWING

THE NUMBER OF PEOPLE IN THE UNITED STATES WITH MODERATE TO SEVERE MR IS EXPECTED TO DOUBLE BY 20301

Mitral regurgitation is severely under-referred and under-treated

Prevalence of MR

  • 2% of the U.S. population has primary MR5
  • 1 out of 5 heart failure (HF) patients has moderate to severe or severe secondary MR6-11

MITRAL REGURGITATION KILLS

If left untreated, MR can initiate a cascade of events leading to heart failure and death, with a 1-year mortality up to 57%.12


74% of eligible patients with primary MR were not referred for surgery for valve replacement.13 Furthermore, nearly 50% of all MR patients will be denied valve replacement surgery due to risks.14


When patients symptoms persist despite maximally tolerated medical therapy and surgery is not a viable option, there are minimally invasive options available to treat these patients.

Woman doing cardio training on a spinning bike

Many patients can benefit
from a less invasive
procedure for the treatment
of Mitral Regurgitation (MR)

For select patients suffering from mitral regurgitation, a less invasive option to repair the mitral valve is required.

Learn more about transcatheter mitral valve repair

change the course for these patients with a MitraClip™ referral

MitraClip is a well-established procedure

2020 ACC/AHA Guideline recommends TEER for Primary and now, Secondary* MR Patients.

LEARN MORE ABOUT MITRACLIP procedure

†Data on file at Abbott
*Secondary MR patients despite optimal GDMT

MAT-2410455 v1.0 | Item approved for U.S. use only

References
  1. De Backer O, Piazza N, Banai S, et al. Percutaneous transcatheter mitral valve replacement: an overview of devices in preclinical and early clinical evaluation. Circ Cardiovasc Interv. 2914;7(3):400-409.
  2. Millennium Research Group. US Markets for Heart Valve Devices 2014. 2013;RPUS12HV13:151.
  3. Mills J, Furlong C. CANACCORD: Biomedical Devices and Services. Nov 8, 2016 and Millenium Research Group. US Markets for Heart Valve Devices 2014. 2013; RPUS12HV13:92.
  4. Stuge O, Liddicoat J. Emerging opportunities for cardiac surgeons within structural heart disease. J Thorac Cardiovasc Surg. 2006;132(6):1258-1261.
  5. Adams DH, Rosenhek R, Falk V. Degenerative mitral valve regurgitation: best practice revolution. Eur Heart J. 2010;31(16):1958-1966.
  6. Benjamin EJ, Blaha MJ, Chiuve SE, et al; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics-2017 update: a report from the American Heart Association. Circulation. 2017;135(10):e146-e603.
  7. Yancy CW, Jessup M, Bozkurt B, et al; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013;62(16):e147-e239.
  8. Pecini R, Thune JJ, Torp-Pedersen C, et al. The relationship between mitral regurgitation and ejection fraction as predictors for the prognosis of patients with heart failure. Eur J Heart Fail. 2011;13(10):1121-1125.
  9. Asgar A, Mack MJ, Stone GW. Secondary mitral regurgitation in heart failure: pathophysiology, prognosis, and therapeutic considerations. J Am Coll Cardiol. 2015;65(12):1231-1248.
  10. Nieminen, MS, Brutsaert D, Dickstein K, et al; EuroHeart Survey Investigators; Heart Failure Association, European Society of Cardiology. EuroHeart Failure Survey II (EFFS II): a survey on hospitalized acute heart failure patients: description of population. Eur Heart J. 2006;27(22):2725-2736.
  11. Patel JB, Borgeson DD, Barnes ME, et al. Mitral regurgitation in patients with advanced systolic heart failure. J Cardiac Fail. 2004;10(4):285-291.
  12. Cioffi G, Tarantini L, De Feo S, et al. Functional mitral regurgitation predicts 1-year mortality in elderly patients with systolic chronic heart failure. Eur J Heart Fail. 2005;7(7):1112-1117.
  13. Bach DS, Awais M, Gurm HS, Kohnstamm S. Failure of guideline adherence for intervention in patients with severe mitral regurgitation. J Am Coll Cardiol. 2009;54(9):860-865.
  14. Mirabel M, Iung B, Baron G, et al. What are the characteristics of patients with severe, symptomatic, mitral regurgitation who are denied surgery? Eur Heart J. 2007;28(11):1358-1365.

  15. Nkomo et al. Burden of Valvular Heart Diseases: A Population-based Study, Lancet, 2006; 368: 1005-11.

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Important Safety Information

Rx Only
Important Safety Information

MITRACLIP™ CLIP DELIVERY SYSTEM

  • The MitraClip™ 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 MitraClip™ 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.

 

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