MitraClip G4: Tailored. Optimized. Proven.

How tech advances are helping physicians improve patient lives.

Healthy Heart|Sep.24, 2020

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.





XIENCE Skypoint™, XIENCE Sierra™, XIENCE Alpine™ (XIENCE™ Family) Everolimus Eluting Coronary Stent Systems

Indications: The XIENCE Skypoint™, XIENCE Sierra™ and XIENCE Alpine™ Stent Systems are indicated for improving coronary artery luminal diameter in patients, including those at high risk for bleeding and those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32 mm) with reference vessel diameters of ≥ 2.25 mm to ≤ 4.25 mm.. In addition, the XIENCE Skypoint™, XIENCE Sierra™ and XIENCE Alpine™ Stent Systems are indicated for treating de novo chronic total coronary occlusions.

Contraindications: The XIENCE Skypoint™, XIENCE Sierra™ and XIENCE Alpine™ Stent Systems are contraindicated for use in:

  • Patients who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or the post-procedural antiplatelet regimen.
  • Patients with hypersensitivity or contraindication to everolimus or structurally-related compounds, or known hypersensitivity to stent components (cobalt, chromium, nickel, tungsten, methacrylic polymer, fluoropolymer), or with contrast hypersensitivity.


  • Each stent and the delivery system are for single use only. Do not reuse, reprocess, or resterilize. Note the product “Use by” date on the package. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and / or delivery system and / or lead to device failure, which may result in patient injury, illness, or death. Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and / or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device and / or delivery system may lead to injury, illness, or death of the patient.
  • It is not recommended to treat patients having a lesion that prevents complete inflation of an angioplasty balloon.
  • Antiplatelet therapy should be administered post-procedure.
  • This product should not be used in patients who are not likely to comply with the recommended antiplatelet therapy.
  • Judicious selection of patients is necessary, since the use of this device carries the associated risk of stent thrombosis, vascular complications, and/or bleeding events.
  • The XIENCE Skypoint™, XIENCE Sierra™ and XIENCE Alpine™ Stent Systems are coated with an everolimus and polymer coating at the full implant stent length.
  • The distal and intermediate portions of the device, the tip, and tapers of the balloon are coated with HYDROCOAT™ Hydrophilic Coating.
  • Failure to abide by the warnings in this labeling might result in damage to the device coating, which may necessitate intervention or result in serious adverse events.


  • Implantation of the stent should be performed only by the physicians who have received appropriate training.
  • Stent placement should be performed at centers where emergency coronary artery bypass graft surgery (CABG) can be readily performed.
  • To confirm sterility has been maintained, ensure that the inner package sterile barrier has not been opened or damaged prior to use.
  • Subsequent restenosis may require repeat dilatation of the arterial segment containing the stent. The long-term outcome following repeat dilatation of the stent is unknown at present.
  • Care should be taken to control the guiding catheter tip during stent delivery, deployment, and balloon withdrawal. Before withdrawing the stent delivery system, visually confirm complete balloon deflation by fluoroscopy to avoid guiding catheter movement into the vessel and subsequent arterial damage.
  • When the XIENCE Skypoint™, XIENCE Sierra™ and XIENCE Alpine™ Stent Systems are used outside the specified Indications for Use, patient outcomes may differ from the results observed in the SPIRIT family of clinical trials.
  • Compared to use within the specified indications for use, the use of the XIENCE Skypoint™, XIENCE Sierra™ and XIENCE Alpine™ Stent Systems in patients and lesions outside of the labeled indications, including more tortuous anatomy, may have an increased risk of adverse events, including stent thrombosis, stent embolization, MI, or death.
  • The extent of the patient’s exposure to drug and polymer is directly related to the number of stents implanted. See Instructions for Use for current data on multiple stent implantation.
  • Safety and effectiveness of the XIENCE Skypoint™, XIENCE Sierra™ and XIENCE Alpine™ Stent Systems have not been established for subject populations with the following clinical settings:
    - Patients with prior brachytherapy of the target lesion or the use of brachytherapy for treated site restenosis.
    - Conjunctive use of the XIENCE Skypoint™, XIENCE Sierra™ and XIENCE Alpine™ Stent Systems with either mechanical atherectomy devices or laser angioplasty catheters.
    - Women who are pregnant or lactating, men intending to father children, pediatric.
    - Unresolved vessel thrombus at the lesion site, coronary artery reference vessel diameters < 2.25 mm or > 4.25 mm or lesion lengths > 32 mm, lesions located in saphenous vein grafts, lesions located in unprotected left main coronary artery, ostial lesions, or lesions located at a bifurcation or previously stented lesions, diffuse disease or poor flow (TIMI < 1) distal to the identified lesions, excessive tortuosity proximal to or within the lesion, recent Acute Myocardial Infarction (AMI) or evidence of thrombus in target vessel, multivessel disease, and in-stent restenosis.
  • Formal drug interaction studies have not been performed with the XIENCE Skypoint™, XIENCE Sierra™ or XIENCE Alpine™ Stent Systems because of limited exposure to everolimus eluted from XIENCE Skypoint™, XIENCE Sierra™ and XIENCE Alpine™ Stent Systems.
    - Everolimus, the active ingredient in the stents, is an immunosuppressive agent. Consideration should be given to patients taking other immunosuppressive agents or who are at risk for immune suppression.
    - Oral everolimus use in renal transplant and advanced renal cell carcinoma patients was associated with increased serum cholesterol and triglyceride levels, which in some cases required treatment.
    - Nonclinical testing has demonstrated that the XIENCE Skypoint™, XIENCE Sierra™ and XIENCE Alpine™ Stent Systems in single and in overlapped configurations up to 71 mm in length, are MR Conditional. See Instructions for Use for detailed scanning conditions

Potential Adverse Events: Adverse events that may be associated with PCI treatment procedures and the use of a stent in native coronary arteries include, but are not limited to, the following:

  • Allergic reaction or hypersensitivity to latex, contrast agent anesthesia, device materials, and drug reactions to everolimus, anticoagulation, or antiplatelet drugs
  • Vascular access complications which may require transfusion or vessel repair, including: Catheter site reactions, Bleeding, Arteriovenous fistula; pseudoaneurysm, aneurysm, dissection, perforation/rupture, Embolism, Peripheral nerve injury, Peripheral ischemia
  • Coronary artery complications which may require additional intervention, including: Total occlusion or abrupt closure, Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection. Perforation/rupture, Tissue prolapse/plaque shift, Embolism, Coronary or stent thrombosis, Stenosis or restenosis
  • Pericardial complications which may require additional intervention, including: Cardiac tamponade, Pericardial effusion, Pericarditis.
  • Cardiac arrhythmias
  • Cardiac ischemic conditions (including myocardial ischemia, myocardial infarction (including acute), coronary artery spasm, and unstable or stable angina pectoris)
  • Stroke/Cerebrovascular Accident (CVA) and Transient Ischemic Attack (TIA)
  • System organ failures: Cardio-respiratory arrest, Cardiac failure, Cardiopulmonary failure, Renal Insufficiency/failure, Shock
  • Bleeding
  • Blood cell disorders
  • Hypotension and/or hypertension
  • Infection
  • Nausea and vomiting
  • Palpitations
  • Dizziness
  • Syncope
  • Chest Pain
  • Fever
  • Pain
  • Death

The risks described below include the anticipated adverse events relevant for the cardiac population referenced in the contraindications, warnings and precaution sections of the everolimus labels / SmPCs and / or observed at incidences ≥ 10% in clinical trials with oral everolimus for different indications. Please refer to the drug SmPCs and labels for more detailed information and less frequent adverse events.

  • Abdominal pain
  • Anemia
  • Angioedema
  • Arterial Thrombotic Events
  • Bleeding and coagulopathy
  • Constipation
  • Cough
  • Diabetes mellitus
  • Diarrhea
  • Dyspnea
  • Embryo-fetal toxicity
  • Erythema
  • Erythroderma
  • Headache
  • Hepatic artery thrombosis
  • Hepatic disorders
  • Hypersensitivity to everolimus active substance, or to other rapamycin derivates
  • Hypertension
  • Infections (bacterial, fungal, viral or protozoan infections, including infections with opportunistic pathogens). Polyoma virus-associated nephropathy (PVAN), JC virus-associated progressive multiple leukoencephalopathy (PML), fatal infections and sepsis have been reported in patients treated with oral everolimus
  • Kidney arterial and venous thrombosis
  • Laboratory test alterations
  • Lymphoma and skin cancer
  • Male infertility
  • Menstrual irregularities
  • Nausea
  • Nephrotoxicity
  • Non-infectious pneumonitis
  • Oral ulcerations
  • Pain
  • Pancreatitis
  • Pericardial effusion
  • Peripheral edema
  • Pleural effusion
  • Pneumonia
  • Pyrexia
  • Rash
  • Renal Failure
  • Upper respiratory tract infection
  • Urinary tract infection
  • Venous thromboembolism
  • Vomiting
  • Wound healing complications

Live vaccines should be avoided and close contact with those that have had live vaccines should be avoided. Fetal harm can occur when administered to a pregnant woman. There may be other potential adverse events that are unforeseen at this time.