CARDIOVASCULAR
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BREAKTHROUGH THERAPY FOR SELECT HIGH-SURGICAL-RISK PATIENTS

MitraClip is the world’s first transcatheter mitral valve repair (TMVr) therapy that delivers a treatment option for patients with significant, symptomatic mitral regurgitation who would otherwise go untreated.1,2 Used in over 70,000 patients worldwide, MitraClip is a well-established procedure with a growing body of clinical and real-world experience.*

 

*Worldwide data as of November 2018, on file at Abbott.

MINIMALLY INVASIVE PROCEDURE

The MitraClip procedure is a minimally invasive catheter-based therapy performed by multidisciplinary Heart Teams.1 Open-heart surgery to repair or replace the mitral valve is generally recommended, but it is not an option for many patients. TMVr with MitraClip therapy delivers a treatment option for select high-surgical-risk patients who would otherwise go untreated.1-3

Clinically important results in patients with significant, symptomatic mitral regurgitation (MR) demonstrate1,2:

  • Positive safety profile
  • Reduction in MR
  • Improvement in patient symptoms
  • Reduction in hospitalizations for heart failure
  • Short hospital length of stay

References

1. MitraClip NTR XTR Clip Delivery System 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. Nishimura RA, et al. 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;135(25):e1159-e1195.

FIRST-IN-CLASS TECHNOLOGY

The MitraClip procedure is performed using venous access and real-time imaging (echocardiography and fluoroscopy), thereby avoiding cardiopulmonary bypass. The MitraClip device grasps and coapts the mitral valve leaflets, resulting in fixed coaptation (approximation) of the mitral leaflets throughout the cardiac cycle.1

  • Femoral venous access
  • Beating heart procedure—no cardiopulmonary bypass
  • Allows for real-time MR reduction assessment
  • Ability to reposition clip for optimal MR reduction
  • Designed to preserve surgical options

INNOVATIVE CLIP DELIVERY SYSTEM

The Clip Delivery System—introduced into the body through a Steerable Guide Catheter—includes the MitraClip device attached to a highly maneuverable delivery catheter, with all controls at the proximal end.1

MitraClip Delivery System

“MitraClip

THE MITRACLIP DEVICE FEATURES1:

  • Cobalt chromium construction
  • Polyester cover designed to promote tissue growth
  • Magnetic resonance conditional to 3 tesla (T)*

*Static magnetic field up to 3 T; maximum spatial gradient in static field of 2500 gauss/cm or less; maximum whole-body averaged specific absorption rate (SAR) of 3.0 W/kg for 15 minutes of scanning.

MORE OPTIONS, MORE POSSIBILITIES

We continue to innovate with the third generation of MitraClip, which allows you to treat your everyday cases and more complex cases with greater ease.*

  • MitraClip NTR: the original NT Clip size on an improved Clip Delivery System (CDS) is designed to be more precise and predictable through new ease-of-use features
  • MitraClip XTR: features longer Clip arms for easier grasping and better reach*,† on an improved CDS

 

MitraClip NTR and MitraClip XTR

Learn More About Our MitraClip Device Innovations

 

*Tests performed by and data on file at Abbott.
Performance of MitraClip XTR is in comparison to previous generation of MitraClip NT system.
This figure reflects the additional grasping width at 120º achieved with the MitraClip XTR Clip.

 

References

1. MitraClip NTR XTR Clip Delivery System 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.

SUCCESSFUL AND DURABLE OUTCOMES WITH MITRACLIP THERAPY*

The longest, prospective follow up of degenerative mitral regurgitation (DMR) patients at prohibitive surgical risk who were treated with MitraClip therapy has shown that clinical benefits remain durable out to 5 years3:

  • Reduction in mitral regurgitation (MR) severity
  • Reduction and stability of left ventricular (LV) volumes
  • Improvement in NYHA Functional Class
  • No new or ongoing safety concerns through 5 years

Reduction in MR severity is durable out to 5 years3

Reduction in MR severity with MitraClip

 

 

Improvement in LV end diastolic volume is durable out to 5 years3

Improvement in NYHA Functional Class with MitraClip

 

 

Improvement in NYHA Functional Class is durable out to 5 years3

Improvement in NYHA Functional Class with MitraClip

RATE OF HOSPITALIZATION FOR HEART FAILURE1,‡

Reduction in the rate of hospitalizations for heart failure

Reduction in hospitalizations for heart failure with MitraClip

*A prohibitive risk DMR cohort (n=127) was retrospectively identified among high risk patients enrolled in the EVEREST II studies. Clinical outcomes of MitraClip therapy assessed at 5 years included survival, MR severity, change in LV volumes and dimensions, and NYHA Class.
†In surviving patients with paired data.
‡A reduction on heart failure hospitalizations was reported in the 12 months post-MitraClip procedure from 12 months pre-MitraClip procedure.2

hospital length of stay

FAVORABLE SAFETY PROFILE

Study results demonstrate the safety of the MitraClip device despite the majority of patients being elderly with a high rate of serious comorbidities.1

  • Low procedural mortality rate of 6.3%
  • No elevated risk of mortality in patients who had the MitraClip procedure over non-surgical management
  • 18.9% of patients experienced a major adverse event at 30 days, with transfusion (12.6%) being the most common event

For additional efficacy and safety results with MitraClip therapy, visit www.MitraClip.com

 

 



References

1. MitraClip NTR XTR Clip Delivery System 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. Lim DS, et al. 5-year durability results of transcatheter mitral valve repair with the MitraClip system in patients with severe degenerative mitral regurgitation and prohibitive surgical risk. J Am Coll Cardiol. 2018;71(11 Supplement):A1262. DOI: 10.1016/S0735-1097(18)31803-5

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

rx-only-logoMITRACLIP CLIP DELIVERY SYSTEMS

 

INDICATION FOR USE

The MitraClip® 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.

CONTRAINDICATIONS

  • Patients who cannot tolerate procedural anticoagulation or post procedural antiplatelet regimen
  • 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 MitraClip® outside of the labeled indication. Treatment of non-prohibitive risk DMR patients should be conducted in accordance with standard hospital practices for surgical repair and replacement.
  • MitraClip® is intended to reduce mitral regurgitation. The MitraClip® procedure is recommended to be performed when an experienced heart team has determined that reduction of MR to ≤ 2+ is reasonably expected following the MitraClip®. If MR reduction to ≤ 2+ is not achieved, the benefits of reduced symptoms and hospitalizations, improved quality of life, and reverse LV remodeling expected from MitraClip® may not occur.
  • The MitraClip® 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. Failure to follow these instructions, warnings and precautions may lead to device damage, user injury or patient injury. Use universal precautions for biohazards and sharps while handling the MitraClip® System to avoid user injury.
  • Use of the MitraClip® should be restricted to those physicians trained to perform invasive endovascular and transseptal procedures and those trained in the proper use of the system.
  • 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 or other serious injury or death.

PRECAUTIONS

  • 
Patient Selection:
    • 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
        • ≥8% for patients deemed likely to undergo mitral valve replacement or
        • ≥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 DMR patients with an LVEF < 20% or an LVESD > 60 mm. MitraClip® should be used only when criteria for clip suitability for DMR have been met.
  • The major clinical benefits of the MitraClip® Implant are a reduction of MR to ≤ 2+ resulting in reduced hospitalizations, improved quality of life, reverse LV remodeling and symptomatic relief in patients who have no other therapeutic option. No mortality benefit following MitraClip® therapy has been demonstrated.

  • 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.
  • The heart team may determine an in-person surgical consult is needed to complete the assessment of prohibitive risk. The experienced mitral valve surgeon and heart team should take into account the outcome of this surgical consult when making the final determination of patient risk status.
  • For reasonable assurance of device effectiveness, pre-procedural evaluation of the mitral valve and underlying pathologic anatomy and procedural echocardiographic assessment are essential.
  • 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.

SPECIAL PATIENT POPULATIONS

  • Mitral Valve Etiology
    Safety and effectiveness of the MitraClip® device has not been established in patients with MR due to underlying ventricular pathology (functional mitral regurgitation or FMR).
  • Pregnancy
    The MitraClip® device has not been tested in pregnant women. Effects on the developing fetus have not been studied. The risks and reproductive effects are unknown at this time.
  • Gender
    No safety or effectiveness related gender differences were observed in clinical studies.
  • Ethnicity
    Insufficient subject numbers prevent ethnicity-related analyses on the clinical safety and effectiveness.
  • Pediatrics
    Safety and effectiveness of the MitraClip® device has not been established in pediatric patients.
  • Anatomic Considerations
    For optimal results, the following anatomic patient characteristics should be considered. The safety and effectiveness of the MitraClip® outside of these conditions has not been established. Use outside these conditions may interfere with placement of the MitraClip® Implant or mitral valve leaflet insertion.
    • The primary regurgitant jet is non-commissural.
If a secondary jet exists, it must be considered clinically insignificant
    • Mitral valve area ≥ 4.0 cm2
    • Minimal calcification in the grasping area
    • No leaflet cleft in the grasping area
    • Flail width < 15 mm and flail gap < 10 mm

POTENTIAL COMPLICATIONS AND ADVERSE EVENTS

The following ANTICIPATED EVENTS have been identified as possible complications of the MitraClip® procedure.

Allergic reaction (anesthetic, contrast, Heparin, nickel alloy, latex); Aneurysm or pseudo-aneurysm; Arrhythmias; Atrial fibrillation; Atrial septal defect requiring intervention; Arterio-venous fistula; Bleeding; Cardiac arrest; Cardiac perforation; Cardiac tamponade / Pericardial Effusion; Chordal entanglement / rupture; Coagulopathy; Conversion to standard valve surgery; Death; Deep venous thrombus (DVT); Dislodgement of previously implanted devices; Dizziness; Drug reaction to anti-platelet / anticoagulation agents / contrast media; Dyskinesia; Dyspnea; Edema; Emboli (air, thrombus, MitraClip® Implant); Emergency cardiac surgery; Endocarditis; Esophageal irritation; Esophageal perforation or stricture; Failure to deliver MitraClip® to the intended site; Failure to retrieve MitraClip® System components; Fever or hyperthermia; Gastrointestinal bleeding or infarct; Hematoma; Hemolysis; Hemorrhage requiring transfusion; Hypotension / hypertension; Infection; Injury to mitral valve complicating or
preventing later surgical repair; Lymphatic complications; Mesenteric ischemia; MitraClip® Implanterosion, migration or malposition; MitraClip® Implant thrombosis; MitraClip® System component(s) embolization; Mitral stenosis; Mitral valve injury; Multi-system organ failure; Myocardial infarction; Nausea / vomiting; Pain; Peripheral ischemia; Prolonged angina; Prolonged ventilation; Pulmonary congestion; Pulmonary thrombo-embolism; Renal insufficiency or failure; Respiratory failure / atelectasis / pneumonia; Septicemia; Shock, Anaphylactic or Cardiogenic; Single leaflet device attachment (SLDA); Skin injury or tissue changes due to exposure to ionizing radiation; Stroke or transient ischemic attack (TIA); Urinary tract infection; Vascular trauma, dissection or occlusion; Vessel spasm; Vessel perforation or laceration; Worsening heart failure; Worsening mitral regurgitation; Wound dehiscence

 

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