In this unpredictable environment, Abbott has proved to be a consistent performer with its diversified business model and robust product portfolio.
This has translated to another dividend increase: an 8.5% boost to the quarterly dividend payouts for 2023, paying out at 51 cents per share.
This marks the 51st consecutive year Abbott has raised its dividend payout, and it’s the 396th consecutive quarterly dividend to be paid by Abbott since 1924. The company is a longtime member of the prestigious S&P 500 Dividend Aristocrats Index, comprising companies that have raised their dividend payout for at least 25 years.
Fueling this increase is strength across the company's diversified businesses and continued investment in its new product pipeline.
In 2022, Abbott's key growth-drivers expanded beyond the company's FreeStyle Libre system, MitraClip and Alinity to also include a number of minimally invasive cardiovascular technologies:
Combined, these new cardiovascular technologies are growing 50% and are still "in the early innings of growth," said Abbott Chairman and CEO Robert Ford during the company's third quarter earnings call.
Fifty-one years of dividend increases demonstrates Abbott's longstanding commitment to delivering sustainable growth that fuels innovations as well as shareholder returns.
Learn more about Abbott's latest quarterly dividend increase.
IMPORTANT SAFETY INFORMATION
FREESTYLE LIBRE 3 SYSTEM
MITRACLIP SYSTEM
AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER
AVEIR LEADLESS PACEMAKER SYSTEM
CARDIOMEMS
FREESTYLE LIBRE 2 SYSTEM
The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older.*WARNINGS/LIMITATIONS*:
The System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems. Remove the sensor before MRI, CT scan, X-ray, or diathermy treatment. Do not take high doses of vitamin C (more than 500 mg per day), as this may falsely raise your Sensor readings. Failure to use the System according to the instructions for use may result in missing a severe low blood glucose or high blood glucose event and/or making a treatment decision that may result in injury. If glucose alarms and readings from the System do not match symptoms or expectations, use a fingerstick blood glucose value to make diabetes treatment decisions. Seek medical attention when appropriate and contact Abbott Toll Free (855-632-8658) or visit * www.freestylelibre.us for detailed indications for use and safety information.
*Please refer to www.freestylelibre.us for the indications and important safety information.
FREESTYLE LIBRE 3 SYSTEM
Failure to use FreeStyle Libre 3 system as instructed in labeling may result in missing a severe low or high glucose event and/or making a treatment decision, resulting in injury. If glucose alarms and readings do not match symptoms or expectations, use a fingerstick value from a blood glucose meter for treatment decisions. Seek medical attention when appropriate or contact Abbott at 855-632-8658 or FreeStyleLibre.us for safety info.
MITRACLIP SYSTEM
INDICATION FOR USE • The MitraClipTM G4 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 MitraClipTM G4 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 MitraClipTM G4 System is contraindicated in patients with the following conditions: • Patients who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or post procedural anti-platelet regimen • Patients with known hypersensitivity to clip components (nickel / titanium, cobalt, chromium, polyester), or with contrast sensitivity • 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 MitraClipTM outside of the labeled indication. • The MitraClipTM G4 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. Use universal precautions for biohazards and sharps while handling the MitraClipTM G4 System to avoid user injury. Failure to follow these instructions, warnings and precautions may lead to device damage, user injury or patient injury including: n MitraClipTM G4 Implant erosion, migration or malposition n Failure to deliver MitraClipTM G4 Implant to the intended site n Difficulty or failure to retrieve MitraClipTM G4 system components • 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 MitraClipTM in these patients has not been evaluated. • Patients with a rotated heart due to prior cardiac surgery in whom the System is used may have a potential risk of experiencing adverse events such as atrial perforation, cardiac tamponade, tissue damage, and embolism which may be avoided with preoperative evaluation and proper device usage. • For the Steerable Guide Catheter and Delivery Catheter only: • The Guide Catheter: the distal 65 cm of the Steerable Guide Catheter with the exception of the distal soft tip, is coated with a hydrophilic coating. The Delivery Catheter: coated with a hydrophilic coating for a length of approximately 131 cm. • Failure to prepare the device as stated in these instructions and failure to handle the device with care could lead to additional intervention or serious adverse event. • 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 and other serious injury or death. • 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. PRECAUTIONS • Prohibitive Risk Primary (or degenerative) Mitral Regurgitation n 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 4 ≥8% for patients deemed likely to undergo mitral valve replacement or 4 ≥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 Primary patients with an LVEF < 20% or an LVESD > 60 mm. MitraClipTM should be used only when criteria for clip suitability for Primary 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 MitraClipTM G4 procedure. • Allergic reactions or hypersensitivity to latex, contrast agent, anaesthesia, device materials (nickel / titanium, cobalt, chromium, polyester), and drug reactions to anticoagulation, or antiplatelet drugs • Vascular access complications which may require transfusion or vessel repair including: n wound dehiscence n catheter site reactions n Bleeding (including ecchymosis, oozing, hematoma, hemorrhage, retroperitoneal hemorrhage) • Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation / rupture, vascular occlusion n Emboli (air thrombotic material, implant, device component) n Peripheral Nerve Injury • Lymphatic complications • Pericardial complications which may require additional intervention, including: • Pericardial effusion n Cardiac tamponade n Pericarditis • Cardiac complications which may require additional interventions or emergency cardiac surgery, including: • Cardiac perforation • Atrial septal defect • Mitral valve complications, which may complicate or prevent later surgical repair, including: • Chordal entanglement / rupture • Single Leaflet Device Attachment (SLDA) • Thrombosis • Dislodgement of previously implanted devices • Tissue damage • Mitral valve stenosis n Persistent or residual mitral regurgitation • Endocarditis • Cardiac arrhythmias (including conduction disorders, atrial arrhythmias, ventricular arrhythmias) • Cardiac ischemic conditions (including myocardial infarction, myocardial ischemia, and unstable / stable angina) • Venous thromboembolism (including deep vein thrombosis, pulmonary embolism, post procedure pulmonary embolism) • Stroke / Cerebrovascular accident (CVA) and Transient Ischemic Attack (TIA) • System organ failure: • Cardio-respiratory arrest • Worsening heart failure • Pulmonary congestion • Respiratory dysfunction / failure / atelectasis • Renal insufficiency or failure • Shock (including cardiogenic and anaphylactic) • Blood cell disorders (including coagulopathy, hemolysis, and Heparin Induced Thrombocytopenia (HIT)) • Hypotension / hypertension • Infection including: • Urinary Tract Infection (UTI) • Pneumonia • Septicemia • Nausea / vomiting • Chest pain • Dyspnea • Edema • Fever or hyperthermia • Pain • Death • Fluoroscopy, Transesophageal echocardiogram (TEE) and Transthoracic echocardiogram (TTE) -related complications: • Skin injury or tissue changes due to exposure to ionizing radiation • Esophageal irritation • Esophageal perforation • Gastrointestinal bleeding. Caution: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use provided inside the product carton (when available) or at eifu.abbottvascular.com or at medical.abbott/manuals for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. TM Indicates a trademark of the Abbott Group of Companies. www.Cardiovascular.Abbott
AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER
The Amplatzer™ Amulet™ Left Atrial Appendage Occluder is a percutaneous transcatheter device intended to reduce the risk of thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular atrial fibrillation and who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are suitable for short term anticoagulation therapy, and have appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation, taking into consideration the safety and effectiveness of the device.
CAUTION: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or at eifu.abbottvascular.com or at Medical.abbott/manuals for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.
CONTRAINDICATIONS
The Amplatzer™ Amulet™ Left Atrial Appendage (LAA) Occluder is contraindicated for patients:
WARNINGS
IMPORTANT SAFETY INFORMATION
The Amplatzer™ Amulet™ device contains a nickeltitanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 120 days. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should be instructed to seek medical assistance immediately if they suspect they are experiencing an allergic reaction. Symptoms may include difficulty in breathing or swelling of the face or throat. While data are currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted.
PRECAUTIONS
MRI SAFETY INFORMATION
Non-clinical testing has demonstrated that the Amplatzer™ Amulet™ Left Atrial Appendage Occluder device is MR Conditional. A patient with the Amplatzer™Amulet™ device can be safely scanned in an MR system under the following conditions:
Under the scan conditions defined above, the device is expected to produce a maximum temperature rise of less than or equal to 4°C after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the device extends radially up to 20 mm from the device when imaged with a gradient echo pulse sequence in a 3.0T MR system.
POTENTIAL ADVERSE EVENTS
Potential adverse events associated with the device or implant procedure include, but are not limited to, the following:
CAUTION: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or at eifu.abbottvascular.com or at medical.abbott/manuals for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events
AVEIR LEADLESS PACEMAKER SYSTEM
Rx Only
Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use
Indications: The Aveir™ Leadless Pacemaker system is indicated for patients with significant bradycardia and:
▪ Normal sinus rhythm with rare episodes of A-V block or sinus arrest
▪ Chronic atrial fibrillation
▪ Severe physical disability
Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity.
Intended Use: The Aveir™ Leadless Pacemaker (LP) is designed to provide bradycardia pacing as a pulse generator with built-in battery and electrodes for implantation in the right ventricle. The LP is intended to provide sensing of intrinsic cardiac signals and delivery of cardiac pacing therapy to the target patient population.
The Aveir™ Delivery Catheter system is intended to be used in the peripheral vasculature and the cardiovascular system to deliver and manipulate an LP. Delivery and manipulation includes implanting an LP within the target chamber of the heart.
Contraindications: Use of the Aveir™ Leadless Pacemaker is contraindicated in these cases:
Use of any pacemaker is contraindicated in patients with a co-implanted ICD because high-voltage shocks could damage the pacemaker and the pacemaker could reduce shock effectiveness.
Single-chamber ventricular demand pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome, have retrograde VA conduction, or suffer a drop in arterial blood pressure with the onset of ventricular pacing.
Programming of rate-responsive pacing is contraindicated in patients with intolerance of high sensor-driven rates.
Use is contraindicated in patients with an implanted vena cava filter or mechanical tricuspid valve because of interference between these devices and the delivery system during implantation.
Persons with known history of allergies to any of the components of this device may suffer an allergic reaction to this device. Prior to use on the patient, the patient should be counseled on the materials (listed in Product Materials section in IFU) contained in the device and a thorough history of allergies must be discussed.
Adverse Events: Potential complications associated with the use of the Aveir™ Leadless Pacemaker system are the same as with the use of single chamber pacemakers with active fixation pacing leads including, but not limited to: Cardiac perforation, Cardiac tamponade, Pericardial effusion, Pericarditis, Valve damage and/or regurgitation, Heart failure, Pneumothorax/hemothorax, Cardiac arrhythmias, Diaphragmatic/phrenic nerve stimulation / extra-cardiac stimulation, Palpitations, Hypotension, Syncope, Cerebrovascular accident, Infection, Hypersensitivity reaction to device materials, medications, or direct toxic effect of contrast media on kidney function, Pacemaker syndrome, Inability to interrogate or program the LP due to programmer or LP malfunction, Intermittent or complete loss of pacing and/or sensing due to dislodgement or mechanical malfunction of the LP (non-battery related), Loss of capture or sensing due to embolization or fibrotic tissue response at the electrode, Increased capture threshold, Inappropriate sensor response, Interruption of desired LP function due to electrical interference, either electromyogenic or electromagnetic, Battery malfunction/ premature battery depletion, Device-related complications (Premature deployment, Device dislodgement/embolization of foreign material, Helix distortion), Death.
As with any percutaneous catheterization procedure, potential complications include, but are not limited to: Vascular access complications (such as perforation, dissection, puncture, groin pain), Bleeding or hematoma, Thrombus formation, Thromboembolism, Air embolism, Local and systemic infection, Peripheral nerve damage, General surgery risks and complications from comorbidities (such as hypotension, dyspnea, respiratory failure, syncope, pneumonia, hypertension, cardiac failure, reaction to sedation, renal failure, anemia, and death).
CARDIOMEMS
By Prescription Only
Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
CardioMEMS™ HF System Indications and Usage: The CardioMEMS HF System is indicated for wirelessly measuring and monitoring pulmonary artery pressure and heart rate in NYHA Class II or III heart failure patients who either have been hospitalized for heart failure in the previous year and/or have elevated natriuretic peptides. The hemodynamic data are used by physicians for heart failure management with the goal of controlling pulmonary artery pressures and reducing heart failure hospitalizations.
Contraindications: The CardioMEMS™ HF System is contraindicated for patients with an inability to take dual antiplatelet or anticoagulants for one month post implant.
CardioMEMS™ HF System Potential Adverse Events: Potential adverse events associated with the implantation procedure include, but are not limited to, the following: air embolism, allergic reaction, infection, delayed wound healing, arrhythmias, bleeding, hemoptysis, hematoma, nausea, cerebrovascular accident, thrombus, cardiovascular injury, myocardial infarction, death, embolization, thermal burn, cardiac perforation, pneumothorax, thoracic duct injury and hemothorax.
myCardioMEMS™ Mobile App Limitations: Patients must use their own Apple‡ or Android‡ mobile device to receive and transmit information to the myCardioMEMS™ Mobile App. To do so the device must be powered on, app must be installed and data coverage (cellular or Wi-Fi‡) available. The myCardioMEMS™ App can provide notification of medication adjustments and reminders, requests for lab work and acknowledgment that the PA pressure readings have been received. However there are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of the notifications and patient information as intended by the clinician. These factors include: patient environment, data services, mobile device operating system and settings, clinic environment, schedule/configuration changes, or data processing.
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