Abbott's pipeline in 2026: A look at the healthcare R&D, clinical programs and product launches shaping future growth

INDICATION FOR USE

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.

CONTRAINDICATIONS

The Amplatzer™ Amulet™ Left Atrial Appendage (LAA) Occluder is contraindicated for patients:

• With the presence of intracardiac thrombus.
• With active endocarditis or other infections producing bacteremia.
• Where placement of the device would interfere with any intracardiac or intravascular structures.

POTENTIAL ADVERSE EVENTS

Potential adverse events associated with the device or implant procedure include, but are not limited to, the following: Air embolism; Airway trauma; Allergic reaction; Anemia; Anesthesia reaction (nausea, vasovagal reaction, confusion/altered mental status or other); Arrhythmia; Atrial septal defect; Bleeding; Cardiac arrest; Cardiac tamponade; Chest pain/discomfort; Congestive heart failure; Death; Device embolization; Device erosion; Device malfunction; Device malposition; Device migration; Device-related thrombus; Fever; Hematuria; Hypertension/hypotension; Infection; Multi-organ failure; Myocardial infarction; Perforation; Pericardial effusion; Pleural effusion; Renal failure/dysfunction; Respiratory failure; Seizure; Significant residual flow; Stroke; Thrombocytopenia; Thromboembolism: peripheral and pulmonary; Thrombus formation; Transient ischemic attack; Valvular regurgitation/insufficiency; Vascular access site injury (hematoma, pseudoaneurysm, arteriovenous fistula, groin pain or other); Vessel trauma/injury.

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 for Use: The AVEIR™ Leadless Pacemaker system is indicated for management of one or more of the following chronic clinical presentations: syncope, pre-syncope, fatigue, disorientation, and one or more of the indications which follow. Rate-modulated pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. Dual-chamber pacing is indicated for patients exhibiting one or more of the following conditions: sick sinus syndrome; chronic, symptomatic second- and third-degree AV block; recurrent Adams-Stokes syndrome; symptomatic bilateral bundle-branch block when tachyarrhythmia and other causes have been ruled out. Atrial pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems. Ventricular pacing is indicated for patients with significant bradycardia and: normal sinus rhythm with only rare episodes of AV block or sinus arrest, or chronic atrial fibrillation. 

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 and the right atrium. The LP is intended to provide sensing of intrinsic cardiac signals and delivery of cardiac pacing therapy within the implanted chamber for the target treatment group. The LP is also intended to operate optionally with another co-implanted LP to provide dual-chamber pacing therapy.

The AVEIR™ Delivery Catheter is intended to be used in the 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:

• In patients with an implanted inferior vena cava filter, femoral access is contraindicated.

• In patients with an implanted superior vena cava filter, internal jugular access is contraindicated.

• Use is contraindicated in patients with a mechanical tricuspid valve because of interference between this device and the delivery system during implantation.

• In patients who are known to be hypersensitive to device material components or a single dose of 1.0 milligram of dexamethasone sodium phosphates.

Adverse Events: Potential complications associated with the use of the AVEIR™ Leadless Pacemaker system are the same as with the use of single or dual chamber pacemakers with active fixation pacing leads including, but not limited to: cardiac arrhythmias; Carotid artery injury; Cardiac perforation; Cardiac tamponade; Cerebrovascular accident (CVA); Death; Diaphragmatic/phrenic nerve stimulation/extra-cardiac stimulation; endocarditis; Heart failure; Hypotension; Hypersensitivity reaction to device materials, contrast media, or medications; Infection; Pacemaker syndrome; Palpitations; Pericardial effusion; Pericarditis; Pneumothorax/Hemothorax; RV-pacing induced cardiomyopathy; Syncope; Thoracic/lymphatic duct injury; Valve damage or regurgitation. Adverse device effects include the following: Battery malfunction/premature battery depletion; Corrupted, intermittent, or loss of i2i™ communication; Device dislodgement; Embolization of foreign material; Helix distortion; Inadequate fixation during implant with or without device migration (Intra-procedural); Inability to interrogate or program the LP due to programmer or LP malfunction; Inability to release/re-dock of the LP from catheter; Inappropriate sensor response; Increased capture threshold (Exit block, High-impedance, Threshold elevation); Intermittent or complete loss of capture, pacing or sensing (non-battery related); Interruption of desired LP function due to electrical interference, either electromyogenic or electromagnetic; Mechanical malfunction of the LP (non-battery related); Oversensing; Premature deployment; Undersensing. As with any percutaneous catheterization procedure, potential complications include, but are not limited to: Air embolism; Bleeding or hematoma; General procedural risks and complications from comorbidities, including but not limited to anesthetic complications, dyspnea, respiratory failure, syncope, pneumonia, hypertension, hypotension, cardiac failure, kidney failure due to reaction to contrast media, pain and anemia; Local and systemic infection; Peripheral nerve damage; Thrombus formation; Thromboembolism; Vascular access complications, such as arteriovenous fistula, pseudoaneurysm, perforation, dissection, puncture, venous occlusion.

Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions, and adverse events.

™ Indicates a trademark of the Abbott group of companies. 

^‡ Indicates a third-party trademark, which is property of its respective owner.

Important Risk Information

Indications for Use

The Cologuard® and Cologuard Plus™ tests are intended for the qualitative detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. A positive result may indicate the presence of colorectal cancer (CRC) or advanced adenoma (AA)/advanced precancerous lesions (APL) and should be followed by a colonoscopy. The Cologuard test and Cologuard Plus test are indicated to screen adults of either sex, 45 years or older, who are at average risk for CRC. These tests are not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.

Do not use the Cologuard products if you have:

• Had adenomas, which are a type of colon polyp that can sometimes become cancer
• inflammatory bowel disease (IBD) or other hereditary syndromes
• a personal or first-degree family history of colorectal cancer
• or a positive result from another colon cancer screening method within that test's recommended screening interval.

Talk to your healthcare provider if any of these situations apply to you.

Cologuard results should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for colonoscopy.

A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their healthcare provider when they need to be tested again.

False positives and false negatives can occur. It is important to talk to your doctor about your test results.

Do not provide a sample if you have diarrhea or have blood in your urine or stool.

The risks related to using the Cologuard collection kit are low, with no serious adverse events reported among people in a clinical trial. You should be careful when opening and closing the lids to avoid the risk of hand strain.

Please read the Instructions for Use and talk to your healthcare provider to see if a Cologuard test is right for you. This product is available by prescription only.

Refer to the Cologuard Patient Brochure or the Cologuard Plus Patient Brochure for additional information on the about the benefits and risk of using each version of the Cologuard product for CRC screening.

FULL INDICATIONS AND IMPORTANT SAFETY INFORMATION

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

GET INFORMED

• Before using the App, please review the complete product instructions and safety information in the User's Manual and take a look at the Interactive Tutorial on our website www.FreeStyleLibre.com. Tips for Kids are there too if you need.
• Be safe and follow the instructions properly. Using the System incorrectly could cause you to miss a severe low or high glucose event and/or make a harmful treatment decision.
• You'll always find the latest version of the User's Manual, including performance data in the Support section at www.FreeStyleLibre.com. If you need a free printed copy, just call Customer Service: 1-855-632-8658, 7 days a week from 8 a.m. to 8 p.m. Eastern Time; excluding holidays.
• Talk to your health care professional about how to use your Sensor glucose information to help manage your diabetes.
• During the first 12 hours of Sensor wear the symbol will display, and you cannot use Sensor values to make treatment decisions during this time. Confirm Sensor glucose readings with a blood glucose test before making treatment decisions during the first 12 hours of Sensor wear when you see the symbol.

COMPATIBLE SENSORS

You can use Libre app with the FreeStyle Libre 3 Sensor and the FreeStyle Libre 3 Plus Sensor (simply referred to as Libre 3 Sensor and Libre 3 Plus Sensor). Some of the information in the User's Manual and the performance characteristics vary between the Sensors. Please reference the labeling content that applies to your Sensor. Make sure you have a Libre 3 Plus Sensor if you plan to connect with a compatible automated insulin dosing (AID) system.

Libre 3 Sensor

• 14 day wear
• Can be used by people age 4 and older
• Do not use with automated insulin dosing (AID) systems
• Taking more than 500 mg of Vitamin C per day may affect Sensor readings. This could cause you to miss a severe low glucose event.

Libre 3 Plus Sensor

• 15 day wear
• Can be used by people age 2 and older
• Can be used with compatible automated insulin dosing (AID) systems
• Taking more than 1000 mg of Vitamin C per day may falsely raise Sensor readings. This could cause you to miss a severe low glucose event. You can take up to 1000 mg of Vitamin C per day and still use the Sensor readings to make treatment decisions.

INDICATION FOR USE

Libre 3 Sensor users:

The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.

The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.

The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions.

Libre 3 Plus Sensor users:

The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the management of diabetes in persons age 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.

The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.

The System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.

CHECK COMPATIBILITY

• Libre app is only compatible with certain phones and operating systems. Always check the Phone and OS Compatibility Guide before upgrading your phone or its operating system. This Guide is available in the App's Help Menu and in the Support section on www.FreeStyleLibre.com.
• Authorized compatible products that you can use with your Sensor are also listed at www.FreeStyleLibre.com. Using your Sensor with products that are not on this list may cause inaccurate glucose readings. If you use a computer, you are responsible for keeping it secure and up to date, for example by using anti-virus software and installing system updates.

CONTRAINDICATIONS

Diathermy: Remove all parts of your System before high-frequency electrical heat (diathermy) treatment. The effect of diathermy on the System hasn’t been tested. The exposure may damage the Sensor, which could impact proper device function and cause inaccurate readings.

Automated Insulin Dosing (AID): The Libre 3 Sensor must not be used with AID systems, including closed loop and insulin suspend systems.

WARNINGS

• Don't ignore low or high glucose symptoms. Use your blood glucose meter to make treatment decisions when your Sensor readings don’t match your symptoms or expectations. Get medical attention when appropriate.
• Use your blood glucose meter to make treatment decisions when your Sensor reading doesn’t match how you feel, has no number, or you see the symbol during the first 12 hours of Sensor wear. You cannot use Sensor values to make treatment decisions during the first 12 hours.
• Choking hazard: The System has small parts that may be dangerous if swallowed.
• You must have access to a blood glucose monitoring system. One is not provided when you use the App.

CAUTIONS – OVERALL SYSTEM

What to know before using the System:

• Avoid infection by taking standard precautions for bloodborne pathogens.
• Don't share the App with another person to avoid confusing glucose information.
• The App doesn’t share data with your System’s Reader. Before you start a Sensor, you must choose whether to use the Reader or the App with the Sensor. Once you start a Sensor, you cannot switch your device.
• Make sure that your phone and Sensor Kits are kept in a safe place and under your control. This is important to help stop anyone from accessing or tampering with the System.

Who should not use the System:

• Don't use in people under the age in the Indications for Use. The System is not cleared for use under this age.
• Don't use if you are on dialysis or critically ill. The System hasn’t been evaluated in these groups. Sensor readings may be inaccurate.
• The System hasn’t been evaluated when used with other implanted medical devices, such as pacemakers.

When is Sensor glucose different from blood glucose:

• Glucose levels in interstitial fluid (what your Sensor measures) can be different from blood glucose levels (what your meter measures). You may notice this when your glucose is changing quickly. For example, after eating, taking insulin, or exercising.

CAUTIONS – APP USE

What to know about the App:

• Disable your phone’s automatic operating system (OS) updates. Before updating your phone’s OS or the App, check the Phone and OS Compatibility Guide to see if the App is compatible. This Guide is available in the App’s Help menu and also in the Support section on www.FreeStyleLibre.com. Check it regularly to make sure that your phone and OS remain compatible with the App.
• We may contact you if an App or OS update will make your previously compatible phone incompatible. Make sure that your LibreView account has your current email address to receive important information.
• After an OS update, open the App and check your device settings to make sure it's working properly. Some OS features may impact your ability to get alarms or glucose readings. For example, if you use the iPhone Screen Time feature, add Libre app to the list of Always Allowed apps to ensure that you receive alarms. Or, if you use an Android phone, don’t use the Android Digital Wellbeing app.
• If you restart your phone, open the App to make sure it’s working properly.
• During set up, the App asks for phone permissions. Please allow these. If your phone is not set up properly, you will not be able to use the App and will not get alarms, including the Urgent Low Glucose Alarm. Confirm your settings are as follows:
  • iPhone settings:
    • In the phone settings, keep Bluetooth ON
    • In the phone settings for the App, allow the App to access Bluetooth
    • In the phone settings for the App under Notifications, keep Critical Alerts ON
  • Android phone settings:
    • In the phone settings, keep Bluetooth ON
    • In the phone settings for the App, keep Do Not Disturb access permission ON
    • In the phone settings for the App, keep Nearby Devices permission ON (for Android 12 and above)

Follow the instructions in the App to turn on these settings and permissions. If your phone is not configured correctly, you will see Alarms Unavailable on your screen.

• Android users may need to add Libre app to the list of the apps that will not be restricted or put to sleep.
• If you adjust the phone ringer volume (iPhone) or Media volume (Android) to silent or use the phone do not disturb setting, keep 'Override Do Not Disturb' setting in the App ON for Low Glucose, High Glucose, and Signal Loss Alarms to ensure you receive audible alarms.

For you to receive alarms:

• Keep your phone charged and turned on.
• Don't force close the App. The App must be running in the background to get alarms.
• Always keep your phone within 33 feet of you, with no obstacles between you. The Sensor itself will not issue alarms! If you’re out of range, you may not get alarms. If you want to use the App's optional alarms, keep these turned on.
• Disconnect headphones or speakers from your phone when not in use. You may miss alarm sounds if you don’t.
• Remember that if you have accessories connected to your phone (like wireless headphones or a smartwatch), you may get alarms on only one device, not all.

Go to the Alarms section in the user manual to learn more about the App's alarms.

CAUTIONS – SENSOR USE

What to know before you apply the Sensor:

• The Sensor inserts just under your skin. You may have some bruising or bleeding.
• Clean your hands before handling the Sensor Kit contents. This will help prevent infection.
• Carefully follow the instructions to prepare the application site on the back of your upper arm. This will help your Sensor stay on for the full wear time and not fall off early. Wash the site using a plain soap. Then, dry and clean with an alcohol wipe. This removes any oily residue and helps the Sensor stick. Allow the site to air dry before applying the Sensor.
• Only apply the Sensor to the back of your upper arm. The Sensor may not work properly in other areas. Avoid scars, moles, stretch marks, and lumps. Choose an area that stays mostly flat (no bending or folding) during your day. Keep at least 1 inch away from insulin injection sites.
• Change sites between Sensors so your skin can recover.

What to know about wearing a Sensor:

• Your Sensor's product insert tells you how long you can wear your Sensor. Remember to always have your next Sensor on hand before your current one ends so you can keep getting your glucose readings.
• If your Sensor stops working and you don’t have another Sensor, use another method to check your glucose and make treatment decisions.
• The App can detect when the Sensor isn’t working properly. It will shut your Sensor off and tell you to replace it. This may happen if the Sensor gets knocked off your body, or if there’s a problem with it. Call us if you receive a Replace Sensor message before the end of your wear time. Customer Service: 1-855-632-8658. Available 7 days a week, 8 a.m. to 8 p.m. Eastern Time; excluding holidays.
• Some people may be sensitive to the adhesive that keeps the Sensor attached to the skin. If you notice significant skin irritation around or under your Sensor, remove the Sensor. Contact your health care professional before continuing to use the System.
• Intense exercise may cause your Sensor to loosen due to sweat or Sensor movement. If the Sensor gets loose or its tip comes out of your skin, you may get no readings or unreliable low readings. Remove your Sensor and apply a new one.
• Don’t attempt to reinsert the old one! Call us if any Sensor gets loose or falls off before the end of your wear time. Customer Service: 1-855-632-8658. Available 7 days a week, 8 a.m. to 8 p.m. Eastern Time; excluding holidays. Don't reuse Sensors. The Sensor and Sensor Applicator are designed for single use. Reuse may result in no glucose readings and infection. Not suitable for re-sterilization. Further exposure to irradiation may cause unreliable low results.
• If a Sensor breaks in your body, call your health care professional.

How to store the Sensor Kit:

• Store between 36°F and 82°F. Storing outside this range may cause inaccurate Sensor glucose readings.
• If you think that the temperature may exceed 82°F (for example, in an un-airconditioned home in summer), you should refrigerate your Sensor Kit. Don’t freeze your Sensor Kit.
• Store in a cool, dry place. Don’t store in a parked car on a hot day.
• Store between 10-90% non-condensing humidity.

When to remove the Sensor:

• If the Sensor is becoming loose or if its tip is coming out of your skin, you may get no readings. Or, you may get unreliable readings that don’t match how you feel. Check to make sure your Sensor is not loose. If it’s loose, remove it and apply a new one. Please call Customer Service.
• If you think your glucose readings are incorrect or don’t match how you feel, do a blood glucose test on your finger to check your glucose. If the problem continues, remove the Sensor and apply a new one. Call Customer Service: 1-855-632-8658. Available 7 days a week, 8 a.m. to 8 p.m. Eastern Time; excluding holidays.

When not to use the Sensor:

• Don't use if the Sensor Kit carton or Sensor Applicator look damaged or if tamper label indicates Sensor Applicator has already been opened. Infection may result.
• Don't use if Sensor Kit contents have expired.

Go to the Applying Your Sensor section in the user manual to learn how to prepare and apply your Sensor.

MRI safety information:

• You can safely have a 1.5T or 3T MRI exam while wearing your Sensor, under the conditions listed below. Injury may result if the conditions are not followed. Leave your phone and Reader outside of the exam room. Sensor readings may be inaccurate during the MRI, but System function returns fully back to normal after 1 hour.

SECURITY INFORMATION

• You are responsible for properly securing and managing your phone. If you suspect an adverse cybersecurity event related to the App, contact Customer Service.
• The App is not intended for use on a phone that has been altered or customized to remove, replace or circumvent the manufacturer’s approved configuration or use restriction, or that otherwise violates the manufacturer’s warranty.
• Don't use the App on a jailbroken or rooted device. When used on a jailbroken or rooted device or in the case of a potential cybersecurity event, the App will stop without notification. This means you won't receive alarms and will need to use another method to check your glucose. Please contact Customer Service.
• Use of an unsupported mobile device or OS version may affect App security and functionality. You are responsible for the risks associated with the use of the App on an unsupported mobile device or OS version.
• The App should only be downloaded and/or updated through authorized distributors, including the App Store (iPhone) and Google Play Store (Android).

INTERFERING SUBSTANCES

Libre 3 Sensor

Taking Vitamin C supplements while wearing the Sensor may falsely raise Sensor glucose readings. Taking more than 500 mg of Vitamin C per day may affect the Sensor readings. This could cause you to miss a severe low glucose event. Vitamin C can be found in supplements including multivitamins. Some supplements, including cold remedies such as Airborne® and Emergen-C®, may contain high doses of 1000 mg of Vitamin C. These should not be taken while using the Sensor. See your health care professional to understand how long Vitamin C is active in your body.

Libre 3 Plus Sensor

Taking more than 1000 mg of Vitamin C per day may falsely raise your Sensor readings. This could cause you to miss a severe low glucose event. Vitamin C can be found in supplements including multivitamins and cold remedies such as Airborne® and Emergen-C®. See your health care professional to understand how long Vitamin C is active in your body.

INDICATIONS FOR USE

The MitraClip™ G5 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™ G5 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™ G5 System is contraindicated for use in patients with the following conditions:

• Intolerance, including allergy or untreatable hypersensitivity, to procedural anticoagulation
• Untreatable hypersensitivity to Implant components (nickel- titanium alloy, cobalt-chromium alloy)
• Active endocarditis or other active infection of the mitral valve 

POTENTIAL COMPLICATIONS AND ADVERSE EVENTS

The following events have been identified as possible complications of the MitraClip™ G5 procedure:
Allergic reactions or hypersensitivity to latex, contrast agent, anaesthesia, device materials, and drug reactions to anticoagulation, or antiplatelet drugs, additional treatment/surgery from device-related complications, atrial septal defect, bleeding, blood disorders (including coagulopathy, hemolysis, and Heparin Induced Thrombocytopenia (HIT)), Cardiac arrhythmias (including conduction disorders, atrial arrhythmias, ventricular arrhythmias), Cardiac ischemic conditions (including myocardial infarction, myocardial ischemia, unstable angina, and stable angina), Cardiac perforation, Cardiac tamponade, chest pain, death, Dyspnea, Edema, Embolization (device or components of the device), Endocarditis, fever or hyperthermia, Fluoroscopy and Transesophageal echocardiogram (TEE) -related complications: Skin injury or tissue changes due to exposure to ionizing radiation, Esophageal irritation, Esophageal perforation, Gastrointestinal bleeding, Hypotension / hypertension; Infection including: Septicemia; Mitral valve complications, which may complicate or prevent later surgical repair, including: Chordal entanglement / rupture, Single leaflet device attachment (SLDA), dislodgement of previously implanted devices, tissue damage, mitral valve stenosis, worsening, persistent or residual regurgitation, nausea or vomiting, pain, Pericardial effusion, stroke / cerebrovascular accident (CVA) and transient ischemic attack (TIA), system organ failure: cardio-respiratory arrest, worsening heart failure, Pulmonary congestion, Respiratory dysfunction or failure or atelectasis, Renal insufficiency or failure, Shock (including cardiogenic and anaphylactic), Thrombosis, Vascular access complications which may require additional intervention, including: wound dehiscence, bleeding of the access site, Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation (rupture), vascular occlusion, Embolism (air, thrombus), Peripheral nerve injury, Venous thrombosis (including deep vein thrombosis) and thromboembolism (including pulmonary embolism)

INDICATIONS

The TriClip™ G5 System is indicated for improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, who are at intermediate or greater risk for surgery and in whom transcatheter edge-to-edge valve repair is clinically appropriate and is expected to reduce tricuspid regurgitation severity to moderate or less, as determined by a multidisciplinary heart team.

CONTRAINDICATIONS

The TriClip™ G5 System is contraindicated for use in patients with the following conditions: Intolerance, including allergy or untreatable hypersensitivity, to procedural anticoagulation; Untreatable hypersensitivity to Implant components (nickel-titanium alloy, cobalt-chromium alloy); Active endocarditis or other active infection of the tricuspid valve.

POTENTIAL ADVERSE EVENTS

The following events have been identified as possible complications of the TriClip™ G5 Procedure. Allergic reactions or hypersensitivity to latex, contrast agent, anaesthesia, device materials and drug reactions to anticoagulation, or antiplatelet drugs; Additional treatment / surgery from device-related complications; Bleeding; Blood disorders (including coagulopathy, hemolysis, and Heparin Induced Thrombocytopenia (HIT)); Cardiac arrhythmias (including conduction disorders, atrial arrhythmias, ventricular arrhythmias); Cardiac ischemic conditions (including myocardial infarction, myocardial ischemia, unstable angina, and stable angina); Cardiac perforation; Cardiac tamponade; Chest pain; Death; Dyspnea; Edema; Embolization (device or components of the device); Endocarditis; Fever or hyperthermia; Fluoroscopy and Transesophageal echocardiogram (TEE) -related complications: Skin injury or tissue changes due to exposure to ionizing radiation, Esophageal irritation, Esophageal perforation, Gastrointestinal bleeding; Hypotension / hypertension; Infection including: Septicemia; Nausea or vomiting; Pain; Pericardial effusion; Stroke / cerebrovascular accident (CVA) and transient ischemic attack (TIA); System organ failure: Cardio-respiratory arrest, Worsening heart failure, Pulmonary congestion, Respiratory dysfunction or failure or atelectasis, Renal insufficiency or failure, Shock (including cardiogenic and anaphylactic); Thrombosis; Tricuspid valve complications, which may complicate or prevent later surgical repair, including: Chordal entanglement / rupture, Single leaflet device attachment (SLDA), Dislodgement of previously implanted devices, Tissue damage, Tricuspid valve stenosis, Worsening, persistent or residual regurgitation; Vascular access complications which may require additional intervention, including: Wound dehiscence, Bleeding of the access site, Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation (rupture), vascular occlusion, Embolism (air, thrombus), Peripheral nerve injury; Venous thrombosis (including deep vein thrombosis) and thromboembolism (including pulmonary embolism).