The MitraClip Story

Breakthrough innovation often requires persistance. Learn how one team brought MitraClip to thousands of people.

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Products and Innovation | June 23, 2016

Breakthrough innovation often requires creativity and persistence. Luckily, the team of pioneering researchers, scientists and doctors who developed MitraClip had a large supply of both. Their determination has helped more than 30,000 people with mitral regurgitation (a potentially fatal heart condition) in 40 countries live a better life1.

Today, as we celebrate "MitraClip Day" around the world, we're recognizing MitraClip – its incredible development journey and the people it helps every day.

It Started with a Bold Idea

MitraClip's story starts in California in the late 1990s. The team at the medical device company Evalve Inc. (purchased by Abbott in 2009) wanted to achieve something new – to use a catheter-based approach to repair the mitral valve in a beating heart. The idea was unheard of. In fact, at the time, some cardiologists were skeptical of the idea.

Sometimes Great Ideas Need a Champion
Ferolyn Powell, who was the CEO of Evalve, led the development of MitraClip. She was convinced the device she was working on would revolutionize therapy for mitral regurgitation (MR), so she put together a multidisciplinary team of people who could help turn this vision into a reality.

The team included Ferolyn’s sister, Liz McDermott, who decided not to retire so she could help by leading the clinical and regulatory groups, and Dr. Fred St. Goar, a cardiologist who sketched the first drawings of this catheter-based device in his lab book.

One of their first meetings took place at a California diner. There, Dr. St. Goar showed the team his drawings. As you can imagine, the discussion largely focused on one key question — could this work?

"Crazy" Ideas Lead to Innovation
Dr. St. Goar’s early sketches gave engineers a place to start.

“There were some crazy ideas and I think the engineering team came up with even crazier ones,” said Troy Thornton, then-Vice President of Research and Development at Evalve. “We tried lots of different things to find what the right path or the best path at the time would be.”

A key engineering moment occurred when the team transitioned from a suture-based approach traditionally used by surgeons who treat the mitral valve to what became the present-day clip.

Watch this video to learn more about mitral regurgitation and how MitraClip works.

A Life-Changing Moment for the First Mitraclip Patient

In 2003, 55-year old Octalina Mendoza from Caracas, Venezuela was the very first patient to receive the MitraClip device to treat her MR.

Her cardiologist, Dr. Jose Condado diagnosed her mitral regurgitation, determining that her heart was pumping harder to accommodate the leak in her mitral valve. As he was planning her treatment, Dr. Condado decided Octalina would be a good candidate for the MitraClip device.

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Octalina Mendoza from Caracas, Venezuela was the first-ever MitraClip patient.

Octalina was treated with the MitraClip device, which successfully reduced her mitral regurgitation without open heart surgery.

“We had shown in real time that you could resolve mitral regurgitation,” said Dr. St. Goar as he reflected on the very first procedure using MitraClip. “This was a game-changing, life-changing moment.”

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The team following the first MitraClip procedure.

Today, more than 30,000 people worldwide have received our MitraClip device 1. This catheter-based, less-invasive treatment option is for treating patients with MR who can't have open-heart surgery due to the risk of death and complications.

Learn more about Octalina Mendoza, the first MitraClip patient.

Reference

1Data as of May31, 2016. Source: Data on file at Abbott Vascular on file

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