INVESTORS
NEWSROOM
Responsibility
SUBSCRIBE
CONSUMERS
HEALTHCARE PROFESSIONALS
CAREERS
ABOUT ABBOTT
How tech advances are helping physicians improve patient lives.
Our MitraClip™ device has been used to provide heart valve repair without surgery to more than 100,000 people worldwide1 with leaking mitral valves.
Our fourth generation MitraClip™ Transcatheter Mitral Valve Repair System, which received U.S. Food and Drug Administration (FDA) approval in 2019 and has now received CE Mark, making this the latest version of our first-of-its-kind device approved for use in the EU.
In addition, over this summer, MitraClip has expanded in new areas throughout the globe. This past summer saw China's first-ever introduction to MitraClip*, and an additional new approval of our enhanced fourth-generation MitraClip G4 device in Japan**.
Indeed, MitraClip usage is on the rise in more than 75 countries around the world and underscores the need for our innovative therapy in new and existing regions where people suffer from the debilitating effects of mitral regurgitation (MR). The latest version of this device offers physicians more treatment options that can be tailored to a patients' unique mitral valve anatomy with predictable procedure experience.2
Here's what to know.
MitraClip G4 Offers New Sizes, Technology
Abbott's MitraClip is used to treat people with primary or secondary MR, also known as a leaky heart valve. MR is a condition in which there's a problem with the mitral valve: the valve's leaflets, or flaps, that should open and close to allow proper blood flow aren't able to close effectively. Rather than allowing blood to flow out to the body as it should, the faulty valve causes blood to move backward within the heart, disrupting proper blood flow. Furthermore, because of this regurgitation, the heart's left chamber may become enlarged, making it difficult for the heart to pump blood.
This condition is progressive and worsens over time without treatment. MitraClip is a small device that clips the valve leaflets together to allow them to function properly and prevent blood from flowing backward through the heart. The device is inserted through a small incision in the leg, making it a minimally invasive option that allows people to avoid open-heart surgery.
While MitraClip has been approved in the EU since 2008 and in the U.S. since 2013, the latest fourth-generation MitraClip offers more clip sizes for tailored repair, allowing doctors the ability to choose clip size based on each mitral valve anatomy. It also has a new leaflet grasping technology called Controlled Gripper Actuation™, which allows physicians to grasp leaflets simultaneously or independently to confirm and optimize leaflet insertion.3 The MitraClip G4 delivery system is specifically designed for the mitral valve to allow precise and controlled steering and facilitates Left Atrial Pressure Monitoring.4
What This Means for People with MR
MitraClip can help select people with mitral regurgitation, especially those who need a minimally invasive therapy to avoid open-heart surgery, which may carry with it risks and complications depending on a patient's age, comorbidities and general condition. Transcatheter mitral valve repair with MitraClip gives people an option – without the potential risks of surgery – and has proven benefits backed by more than 16 years of safety and effectiveness data.
In 2018, Abbott received approval for MitraClip to treat select individuals with heart failure due to secondary MR. People with secondary MR have typically had poor outcomes, with increased hospitalizations and reduced life expectancy.5 The landmark COAPT™ Trial found that people in this group had significant reduction in hospitalizations, and improvements in survival, symptoms, social abilities and overall quality of life when treated with MitraClip.6
Backed by results from the COAPT Trial as well as additional clinical and real-world data of MitraClip usage around the globe, the device has shown improved outcomes and reduction in patients with primary and secondary MR. Click here for more information on MitraClip trials including EVEREST, REALISM, EXPAND and REPAIR MR.
With this body of data and track record of availability beginning in 2008, Abbott is the global leader in transcatheter mitral valve technology, giving eligible people an option for heart valve repair without surgery. The latest-generation MitraClip aims to continue the results seen with previous iterations, bringing this life-saving treatment to even more people in need.
Recently, the U.S. Centers for Medicare & Medicaid Services' (CMS) released a proposed national coverage determination (NCD) to include coverage for the MitraClip therapy for Medicare beneficiaries with significant symptomatic secondary MR. If finalized, MitraClip will be an option to help even more people in the U.S. than it does today.
What's Next in Valve Disease Treatments
We'll continue to invest in pushing valve repair and replacement technologies ahead to help people live their best lives. That includes the U.S.-based TRILUMINATE™ Pivotal Trial underway to evaluate a device to repair the tricuspid valve called TriClip™*** (not available in the U.S.).
With a design based on the MitraClip technology, TriClip will treat people with tricuspid regurgitation and could give people with tricuspid regurgitation a much-needed minimally invasive treatment option. The device recently received CE Mark approval in spring of 2020, making it an important treatment option for people in the EU suffering from severe tricuspid regurgitation.
Repair of the mitral valve isn't always an option when the mitral valve is too damaged. Also approved in the EU (not available in the US) early 2020, our new Tendyne™*** valve, is a minimally invasive mitral valve replacement device that is inserted through a small incision in the chest to replace the natural mitral valve. The valve is currently being studied in the U.S. in our SUMMIT trial.
*MitraClip™ NTR/XTR received approval in China in June 2020 to treat primary MR. **MitraClip G4 received approval in Japan in June 2020 to treat primary and secondary MR. ***The TriClip™ Transcatheter Tricuspid Valve Repair System and Tendyne™ Transcatheter Mitral Valve Implantation System are for investigational use only in the U.S.
1Data on file at Abbott. 2020. 2Rottbauer 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. 3MitraClip G4 IFU. Tests performed by and data on file at Abbott. 4Tests performed by and data on file at Abbott. 5Dwivedi A, Vainrib A, Saric M. Functional mitral regurgitation in patients with heart failure and depressed ejection fraction. Current Opinion in Cardiology. September 2016 - Volume 31 - Issue 5 - p 483–492. 6Nishimura RA. 2017 AHA/ACC focused update of the 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017;136(9):1-123. DOI: 10.1161/CIR.0000000000000503.
Indications and Important Safety Information
Transcatheter Mitral Valve Repair
IMPORTANT SAFETY INFORMATION
MITRACLIP CLIP DELIVERY SYSTEMS
INDICATION 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 MitraClipTM 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 regimen
• 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
WARNINGS
• DO NOT use MitraClipTM outside of the labeled indication.
• The MitraClipTM G4 Implant should be implanted with sterile techniques using fluoroscopy and echocardiography (e.g. transesophageal [TEE] and transthoracic [TTE]) in a facility with on-site cardiac surgery and immediate access to a cardiac operating room.
• Read all instructions carefully. Use universal precautions for biohazards and sharps while handling the MitraClipTM G4 System to avoid user injury. Failure to follow these instructions, warnings and precautions may lead to device damage, user injury or patient injury including:
• MitraClipTM G4 Implant erosion, migration or malposition
• Failure to deliver MitraClipTM G4 Implant to the intended site
• Difficulty or failure to retrieve MitraClipTM G4 system components
• Use caution when treating patients with hemodynamic instability requiring inotropic support or mechanical heart assistance due to the increased risk of mortality in this patient population. The safety and effectiveness of MitraClipTM in these patients has not been evaluated.
• Patients with a rotated heart due to prior cardiac surgery in whom the System is used may have a potential risk of experiencing adverse events such as atrial perforation, cardiac tamponade, tissue damage, and embolism which may be avoided with preoperative evaluation and proper device usage.
• For the Steerable Guide Catheter and Delivery Catheter only:
• The Guide Catheter: the distal 65 cm of the Steerable Guide Catheter with the exception of the distal soft tip, is coated with a hydrophilic coating.
• The Delivery Catheter: coated with a hydrophilic coating for a length of approximately 131 cm.
• Failure to prepare the device as stated in these instructions and failure to handle the device with care could lead to additional intervention or serious adverse event.
• The Clip Delivery System is provided sterile and designed for single use only. Cleaning, re-sterilization and / or reuse may result in infections, malfunction of the device and other serious injury or death.
• Note the product “Use by” date specified on the package.
• Inspect all product prior to use. Do not use if the package is open or damaged, or if product is damaged.
PRECAUTIONS
• Prohibitive Risk Primary (or degenerative) Mitral Regurgitation
• Prohibitive risk is determined by the clinical judgment of a heart team, including a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, due to the presence of one or more of the following documented surgical risk factors:
◆ 30-day STS predicted operative mortality risk score of 4 ≥8% for patients deemed likely to undergo mitral valve replacement or 4 ≥6% for patients deemed likely to undergo mitral valve repair
• Porcelain aorta or extensively calcified ascending aorta.
• Frailty (assessed by in-person cardiac surgeon consultation)
• Hostile chest
• Severe liver disease / cirrhosis (MELD Score > 12)
• Severe pulmonary hypertension (systolic pulmonary artery pressure > 2/3 systemic pressure)
• Unusual extenuating circumstance, such as right ventricular dysfunction with severe tricuspid regurgitation, chemotherapy for malignancy, major bleeding diathesis, immobility, AIDS, severe dementia, high risk of aspiration, internal mammary artery (IMA) at high risk of injury, etc.
• Evaluable data regarding safety or effectiveness is not available for prohibitive risk Primary patients with an LVEF < 20% or an LVESD > 60 mm. MitraClipTM should be used only when criteria for clip suitability for Primary have been met.
• The heart team should include a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease and may also include appropriate physicians to assess the adequacy of heart failure treatment and valvular anatomy.
• Secondary Mitral Regurgitation
• Evaluable data regarding safety or effectiveness is not available for secondary MR patients with an LVEF < 20% or an LVESD > 70 mm.
• The multidisciplinary heart team should be experienced in the evaluation and treatment of heart failure and mitral valve disease and determine that symptoms and MR severity persist despite maximally tolerated GDMT.
POTENTIAL COMPLICATIONS AND ADVERSE EVENTS
The following ANTICIPATED EVENTS have been identified as possible complications of the MitraClipTM 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 effusion
• 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
Abbott 3200 Lakeside Dr., Santa Clara, CA. 95054 USA, Tel: 1.800.227.9902
Caution: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use provided inside the product carton (when available) or at eifu.abbottvascular.com or at medical.abbott/manuals for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. TM Indicates a trademark of the Abbott Group of Companies. www.Cardiovascular.Abbott © 2020 Abbott. All rights reserved. MAT-2004726 v2.0 | Item approved for U.S. use only.