MitraClip Now Helps Many More

With FDA approval for secondary mitral regurgitation treatment, device can help 2-3 times as many patients.

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Products and Innovation | Mar. 14, 2019

Where medication fails, MitraClip saves lives, reduces hospitalizations and dramatically improves quality-of-life in treating advanced heart failure patients with secondary mitral regurgitation.

With FDA approval for secondary mitral regurgitation treatment, MitraClip can help 2-3 times as many patients.1 MitraClip is the only mitral device approved to treat advanced heart failure patients with significant secondary mitral regurgitation (MR). Prior to this approval, the standard of care for most heart failure patients with severe MR was to manage their symptoms with medication, which doesn't treat the underlying cause of MR, a leaky mitral valve.

In over a decade of use, more than 80,000 people worldwide have been treated with MitraClip. The FDA's decision means it's now in position to help many thousands more.

How MitraClip Works

The heart is a pump, sending oxygenated blood throughout the body. Each valve has a purpose to keep blood moving to or from the heart, so the body can operate as intended. Mitral regurgitation occurs when blood backs up in the heart, from either a leaky mitral valve or from valve leaflets that cannot close due to the left chamber of the heart being enlarged from advanced heart failure.

Through a minimally invasive procedure, MitraClip restores normal function to the leaflets of the mitral valve by clipping them together, relieving MR and allowing the heart to pump blood more efficiently throughout the body.

A Groundbreaking Study with Life-Changing Results

For people living with heart failure, the ones who need the most help are often the least capable of receiving it, because of advanced age or frailty or other complicating factors.

But in September of 2018, we saw the results of the landmark COAPTTM Trial, which looked at 614 advanced heart failure patients living with moderate-to-severe and severe secondary mitral regurgitation.

The participants' median age was just over 72 years and more than 60 percent were male.

And the secondary MR they're living with is a tricky prognosis that's difficult to diagnose and manage.

As Neil Moat, chief medical officer for our Structural Heart business says, "Since severe secondary MR is extremely difficult to manage and associated with a very poor prognosis, people have historically had few options. The secondary MR indication for MitraClip opens new doors for these ailing patients and improves both their symptoms as well as their chance for survival."

MitraClip offers a minimally invasive — and safe and effective — alternative that met both of the trial's primary endpoints and all 10 secondary endpoints.

The COAPT Trial shows:

  • MitraClip provides almost immediate symptom relief.
  • On average, people left the hospital after two days.
  • When combined with medical therapy, MitraClip significantly reduced hospitalization in heart failure patients through two years compared to medical therapy alone, dropping from nearly 68 percent to just under 36 percent, annually.
  • One year out from the procedure, freedom from device-related complications was nearly 97 percent, exceeding the study's goal of 88 percent.
  • Two years out, people with MitraClip and medical therapy saw a sharp reduction in all-cause mortality compared to those with medication alone, from just over 46 percent of patients in the control group to just over 29 percent in the device group.

And for patients experiencing significant MR:

  • For MitraClip recipients, severity of their mitral regurgitation was greatly reduced.
  • And those same patients saw a 43 percent reduction in death or first heart failure hospitalization.

Not surprisingly, MitraClip provided a substantial improvement in patients' perception of their health status as measured by the KCCQ quality-of-life score.

Now Approved in the U.S. to Help Many More

The FDA's secondary MR indication for MitraClip means a viable potential treatment for secondary MR is available where it wasn't before.

That's good news for the many patients who may benefit from MitraClip to treat secondary MR and heart failure in addition to those being treated for the primary form of the disease, commonly associated with age.

"This is truly a significant approval for a device that has already helped many tens of thousands of people avoid surgery and get back to their lives," said Michael Dale, vice president of Abbott's structural heart business. "Physicians now have a new option to treat advanced heart failure patients with the secondary form of the disease – helping them stay out of the hospital while improving survival."

Our work in mitral therapy will continue to grow and expand, with MitraClip being used to treat patients in more than 50 countries. It's the kind of innovation the world expects from a leading health technology company and recognized leader.

References

1Goel SS, Bajaj N, Aggarwal B, et al. Prevalence and outcomes of unoperated patients with severe symptomatic mitral regurgitation and heart failure: comprehensive analysis to determine the potential role of MitraClip for this unmet need. J Am Coll Cardiol. 2014;63:185-6.

IMPORTANT SAFETY INFORMATION

MITRACLIP CLIP DELIVERY SYSTEMS

INDICATION FOR USE

The MitraClip™ NTR/XTR Clip Delivery 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™ NTR/XTR Clip Delivery 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™ NTR/XTR Clip Delivery System is contraindicated in patients with the following conditions:

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.

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.

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 MitraClip™ in these patients has not been evaluated.

PRECAUTIONS:

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.

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

≥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 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 MitraClip™ procedure.

Death; 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; 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™ Implant erosion, 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