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ABOUT ABBOTT
Abbott continues to bring forward new innovations to help people live their best lives.
The Chicago Innovation Awards have honored Abbott with a record 7th award for healthcare innovation.
For many years, Abbott has remained a significant force in innovation, discovering and developing new healthcare products and technologies that have helped generations of people to live their best lives. Most recently, Abbott was recognized with another Chicago Innovation Award.a
Abbott innovation goes way back to 1888, when 30-year-old Dr. Wallace C. Abbott, a practicing Chicago physician and drug store proprietor, founded the company. Dr. Abbott’s innovation was revolutionary: he developed tiny pills that allowed more consistent and effective medicinal dosages for patients.
This history of innovation continues today. Abbott received a Chicago Innovation Award for the MitraClip® System, a first-of-its-kind, catheter-based device that has transformed the treatment of certain kinds of mitral regurgitation (MR) for people who are too frail for open-heart surgery or those who are not candidates for surgery
Every year since 2002, the Chicago Innovation Awards recognizes businesses, nonprofits, and government organizations that develop the year’s most innovative new products and services. Abbott has received more Chicago Innovation Awards – seven – than any other company.
Often referred to as a leaky heart valve, MR is a dangerous condition that occurs when blood flows backward through the heart’s mitral valve. Because the heart must work harder to push blood through the body, patients experience fatigue, shortness of breath, increased vulnerability to heart failure and potentially, death.
The MitraClip device, which achieved FDA approval in 2013, is placed in the heart through a blood vessel in the leg – thus avoiding open-heart surgery. Once in position, the MitraClip device pinches, or clips, the leaky valve closed, keeping the blood from flowing backward and easing the strain on the heart.
Watch an animation of the procedure.
Clinical data show that treatment with the MitraClip device reduces the severity of MR, improves physical health and vitality, and decreases recovery time compared to open-heart surgery. To date, the system has been used to treat more than 25,000 people in 40 countries. Find a heart center offering treatment with the MitraClip device.
Ted E. Feldman, M.D., of NorthShore University HealthSystem located in the Chicago area, performed the very first U.S. implant of the device in 2003, and served as the principal investigator of the clinical trial that led to U.S. FDA approval of the device.
"The MitraClip device is a true breakthrough that has really changed the treatment of MR. For the first time, we are able to offer a minimally invasive therapy for many patients who did not have any option in the past. In our experience, many people go from bed rest back to normal daily activities after only a few days," Dr. Feldman said. "It has been extremely gratifying to be involved in the evolution of MitraClip from the very beginning and to see it now in use to improve the lives of thousands of people around the world."
"At Abbott, we are on a mission to help people live their best lives, and innovation is at the center of everything we do," said Robert Ford, executive vice president, Medical Devices, Abbott. "We are honored to be recognized with the Chicago Innovation Award for MitraClip – a first-of-its-kind device that resulted from the ongoing commitment of our employees to develop products that transform people's lives."
Abbott's previous Chicago Innovation Award-winning advances include:
In addition to the seven Chicago Innovation Awards, Miles D. White, Abbott's chairman and chief executive officer, also was recognized with the organization's Visionary Award in 2011.
*HUMIRA is no longer an Abbott product; for more information, visit www.abbvie.com.
IMPORTANT SAFETY INFORMATION
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