Learn to see. Realize that everything connects to everything else.
— Leonardo Da Vinci
You know we’re serious when we bring one of history’s greatest minds into play to illustrate a belief that is at the core of everything we do: the power of connected health.
When it comes to living a full, active life, we agree with Leo. Recognizing the data and decisions that lead to good health is key. So, we are always looking for new ways to foster those connections:
Robert Ford, chairman of the board and chief executive officer, Abbott, put it this way at the HLTH conference:
“The potential for this future — one where our body’s information is clear and understandable, where we can make better-informed decisions, at our fingertips — this is what inspires us at Abbott. It’s a future that pairs health with technology to put us all in greater control. And I’m so excited to say: That future is here.”
This excitement is borne out by a growing number of examples of connected health making a difference in people’s lives right now — and a world of opportunity waiting right around the corner.
Connecting People with Safe, Effective, Efficient Technology
One of our connected health neuromodulation products has literally opened a world of possibilities for people living with chronic pain or movement disorders, like Parkinson’s disease or essential tremor. The NeuroSphere Virtual Clinic is a secure, in-app video chat and remote programming tool, accessible via our patient controller app that can be used on a patient’s own iOS device.
It allows for remote office visits during which the physician can assess the patient and adjust treatment through a hand-held device, with the same capabilities as if they were in the clinic next to them. That message is sent to a stimulator, which delivers mild electrical impulses to treat the patient. The physician can also use the device to assess the effect of the treatment and adjust accordingly.
This freedom allows patients to be examined and treated from any location with a Wi-Fi signal and a sufficiently charged patient controller, saving them the time and extraordinary effort it might take them to get to their doctor.
Think of this as the flip side of our normal electronics experience, actually improving health and saving time using our devices.
“We knew that changing the paradigm and placing control in patients’ hands was important. Equally important was making things more convenient for the doctors, so they could have flexibility from where they are and provide treatment,” said Ryan Lakin, divisional vice president, digital solutions, Abbott Medical Devices.
“In a world where physicians are typically overburdened, it gives them added flexibility that historically they’ve never had, while saving patients from added inconvenience and discomfort.”
As is the case with many connected health devices, success breeds success, and the NeuroSphere myPath app was soon available for patients to be used on both Android and iOS devices.
Before a chronic pain relief device is fully implanted, a trial period of about a week is used to figure out how effective the device is and how it can be optimized. The myPath app allows the patient to document pain relief information, track trial experiences and facilitate doctor-patient communication, allowing full implantation to proceed post-trial with more comprehensive data.
It’s kind of like being able to watch a trailer for the movie about how your life could be better — especially with more data.
Exciting as these innovations are, they’re only the beginning.
“There are big opportunities ahead,” Lakin said. “The advantage of working off smartphones is they get smarter and develop better cameras, voice tools and faster processers, giving them ever-stronger capabilities.”
Connecting with Tools that Provide a Clearer Understanding of Health, 24/7
One of the advantages to evolving connected health technology is the ability to continuously monitor cardiac conditions — like abnormal heart rhythm (i.e., cardiac arrhythmias) — that can address diagnosis and treatment challenges.
Our Assert-IQ Insertable Cardiac Monitor (ICM) provides constant real-time monitoring to identify this condition through a device small enough to be placed just under the skin, powered by a battery, with a life of up to six years.
All of that time and anxiety that heart patients spend wondering what’s to come and what to do about it? This small device is on the case all day, every day.
The ICM remains connected to their smartphone — checking heart rhythms continuously, sending real-time results to a clinic’s portal.
Making the device even more connected, some models allow the clinician to adjust settings to optimize performance and limit unnecessary alerts/transmissions, all without the patient having to visit the clinic, using the remote programming capability built into the system.
Not only does the device provide 24/7 monitoring, it also offers advanced diagnostic capabilities to provide physicians with more clinically relevant information about the cardiovascular health of the patient, allowing them to make informed medical decisions.
Patients want peace of mind. Doctors want data that informs their best decisions. Win-win.
“Assert-IQ delivers important data which helps assess what causes symptoms and connects them with actual clinical events. Our advanced algorithms significantly reduce false positives, making the alerts more reliable,” Lakin said.
“Healthcare should be convenient, and patient centered. We want the people we serve to be in as much control of their health as they choose.”
Tapping into Richer Information to Make Better-informed Decisions
Another cardiovascular connection comes in the form of the AVEIR DR leadless pacemaker, the first such system with an intra-body connection that allows wireless communication between co-implanted devices.
In simpler terms: We have tech talking tech to other tech.
AVEIR DR is the first dual chamber leadless pacemaker approved by the U.S. Food and Drug Administration and is designed for people living with a slow or abnormal heartbeat.
Why is that a big deal?
A couple of reasons. Traditionally, pacemakers have required “leads,” thin wires that start at a generator placed near the collarbone and run down the chest into the heart. But the beauty of the AVEIR DR system is it’s self-contained: Each pacemaker consists of a single unit, smaller than a triple-A battery, implanted directly into the chamber of the heart. Discreet.
You may be thinking: If I have a heart condition, the last thing I’m thinking about is how I look with a few wires and bumps under my clothes.
That just means you don’t have a heart condition. We all care.
But there are bigger things about that smaller package.
With this dual chamber system, physicians can implant two leadless pacemakers, one in the right ventricle and one in the right atrium. These two devices can talk to each other, letting each other know the signals they sense from their chambers, helping the two chambers beat synchronously.
Think of it as the symphony of life. This type of intra-body connection has never been available with a leadless pacemaker before and allows the atrial and ventricular AVEIR units to send communications to one another as often as once every heartbeat to stay coordinated. If the heart needs a boost to beat faster, the system senses it and adjusts in a fraction of a second.
Even your best friends aren’t that quick to help.
“The AVEIR DR system is a great example of connected health with two single devices communicating wirelessly every single cardiac cycle to maintain the cardiac synchrony between two heart chambers,” said Kyungmoo Paul Ryu, Ph.D. senior director, R&D Clinical Engineering and Applied Research. “It does not miss a beat.”
Nor does its data miss an entry. “All of the diagnostic information generated is self-stored in the devices and later will be sent to our patient ecosystem that manages cardiac information for those with implanted devices,” Ryu said.
The system likewise better connects patients with the rest of their lives.
“Both devices are self-contained in the heart, without any wires or requiring subcutaneous device pocket in the chest, which means they aren’t restricted in terms of physical or even cosmetic concerns,” Ryu said.
Like we said: Everyone cares.
More Control, Less Waste, Faster Response and Better Data
A virtual clinic in neuromodulation or remote programming of an ICM that can save hundreds of miles, dozens of hours and endless inconvenience for people who can afford them least.
A monitor that transmits the kind of information that can warn of an approaching cardiac event.
A next-generation pacemaker that allows chambers of the heart to communicate and stay in sync.
All are impressive. And just the beginning of what comes next.
Remember Ryan Lakin, from earlier, who was telling us all about these devices? He’s far from done.
His job is to not only further connect individual technologies and users, but to develop new ways that devices can work together to improve care and provide both patients and healthcare professionals with insights — that are easier to use — so that they can make better-informed decisions.
While there is literally no end in this ever-evolving space, Lakin has identified three broad areas of interest.
Simply put, it’s getting the most useful health data from our connected devices to where the users want it. “No matter our business, from Diagnostics to Diabetes Care to Heart Failure to Neuromodulation, that need is consistent,” Lakin said. “We can, and are, doing better all the time. We’re getting more usable data to care teams within their workflow, which gives them what they need in a form most useful to them.”
The word data can sound dull, but when properly gathered and assessed, it is a life-changer on a regular day, and a lifesaver on a tougher one.
The work is not simple — different care teams use different systems and needs change — but it is vital to make sure each customer has a workable solution that simplifies their work.
“Due to the pandemic and related healthcare worker burnout, it’s absolutely essential for us to ease the burden of data management for both patients and providers,” Lakin said.
“One of the biggest advantages to connected health technology is it can help better identify which patients need what intervention at the right time,” Lakin said. “We’re helping hospital systems better identify high-risk patients who need to be referred to a specialist.
“A few years ago, we started a service within our cardiovascular businesses that helps hospitals — using guidelines and their clinical expertise — build a rules engine within their EMR (Electronic Medical Record) to identify at-risk patients who need a referral to a sub-specialist.”
The impact for patients is clear: Knowing you need help is a great start but knowing the best help to get and getting it at the right time is the stuff of interesting stories to tell for years to come.
“We are also focusing on what role we should play, “said Lakin. “There are so many interesting possibilities. We not only have a lot of connected health devices across our portfolio, but we are always developing more and making them easier to use.
“We’re focused on better ways to move important information, helping people better understand and control their health, while cutting out extra work for providers.”
Admittedly, “digital strategy” is not a phrase that dances across the page, but since it’s shorthand for the innovations that may save or greatly improve the quality of life for someone you love at some point, we hope you understand our fondness for the words.
Making Good Connections, Moving on From Bad Ones
While we understand the value of connection, we feel just as strongly about the power of disconnecting. We are always looking for new ways to improve lives by separating:
We will continue to recognize that everything connects to everything else, enhancing the associations that power our science and removing the impediments to longer, healthier lives. It’s what Leo would want.
IMPORTANT SAFETY INFORMATION
ASSERT-IQ
TACTIFLEX ABLATION CATHETER, SENSOR ENABLED
AVEIR LEADLESS PACEMAKER SYSTEM
AVEIR™ DR
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 management of one or more of the following permanent conditions: Syncope, Pre-syncope, Fatigue, Disorientation. 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: 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, Chronic atrial fibrillation, Severe physical disability.
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/or 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 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:
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 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, contrast media, 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.
MAT-2306873 v1.0 | Item is approved for US Use
ASSERT-IQ
By Prescription Only
Abbott Insertable Cardiac Monitors
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: Abbott ICMs are indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms that may be cardiac-related such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias such as bradycardia, tachycardia, and sinus pauses. Abbott ICMs are also indicated for patients who have been previously diagnosed with atrial fibrillation (AF) or who are susceptible to developing AF. Abbott ICMs are intended to be inserted subcutaneously in the left pectoral region, also described as the left anterior chest wall. Abbott ICMs have not been specifically tested for pediatric use.
Intended Use: Abbott ICMs are intended to help physicians and clinicians monitor, diagnose and document the heart rhythm in patients who are susceptible to cardiac arrhythmias and unexplained symptoms by detecting arrhythmias and transmitting data for review.
Contraindications: There are no known contraindications for the insertion of Abbott ICMs. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated.
Potential Adverse Events: Possible adverse events (in alphabetical order) associated with the device, include the following: allergic reaction, bleeding, chronic nerve damage, erosion, excessive fibrotic tissue growth, extrusion, formation of hematomas or cysts, infection, keloid formation and migration.
Refer to the User’s Manual for detailed indications for use, contraindications, warnings, precautions and potential adverse events.
An Abbott mobile transmitter is available for patients without their own compatible mobile device
TACTIFLEX ABLATION CATHETER, SENSOR ENABLED
CAUTION: This product is intended for use by or under the direction of a physician. Prior to use, reference Instructions for Use, inside the product carton (when available) or at manuals.sjm.com or eifu.abbottvascular.com for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.
Indications: The TactiFlex™ Ablation Catheter, Sensor Enabled™ is indicated for use in cardiac electrophysiological mapping and for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation and concomitant atrial flutter, when used in conjunction with a compatible RF generator and three-dimensional mapping system.
Contraindications: Do not use for any of the following conditions: recent ventriculotomy or atriotomy heart surgery; prosthetic valves; active systemic infection; use in coronary vasculature; myxoma or intracardiac thrombus, transseptal approach with an interatrial baffle or patch; retrograde trans-aortic approach in patients with aortic valve replacement; patients unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation.
Warnings: The temperature data transmitted by the sensor in this catheter is representative of the irrigated electrode only and does not provide tissue temperature data. Application of RF energy on the left atrial posterior wall exceeding 40 W in power, or use of contact force ≥15g, increases the risk of esophageal perforating complications including atrio-esophageal fistula and death. Application of RF energy outside of the power and duration recommendations may increase the likelihood of steam pop occurrence. Patients undergoing septal accessory pathway ablation are at risk for complete AV block which requires the implantation of a permanent pacemaker. Implantable pacemakers and implantable cardioverter/defibrillator (ICDs) may be adversely affected by RF current. The combination of intracoronary placement of the ablation catheter and RF energy application has been associated with myocardial infarction and death. Inspect tubing, connections, and saline irrigation for air bubbles prior to and throughout its use in the procedure. Air or bubbles in the saline irrigation may cause emboli, potential injury, or fatality. Increased contact force may increase the risk for perforation during manipulation of the catheter. Contact force in excess of 20 g may not significantly change the characteristics of lesion formation. Contact force accuracy above 50 g has not been established. Caution should be taken when placing lesions in the proximity of the specialized conduction system. To avoid thromboemboli, intravenous heparin should be used when entering the left heart during ablation. Always maintain a constant saline irrigation flow to prevent coagulation within the lumen of the catheter. When using the catheter with conventional EP lab system (using fluoroscopy to determine catheter tip location) or with a 3D navigational system, careful catheter manipulation must be performed, especially when used in combination with a long sheath, in order to avoid cardiac damage, perforation, or tamponade.
Precautions: Always straighten the catheter tip before insertion or withdrawal. If irrigation flow is interrupted, immediately inspect and re flush the catheter outside of the patient. Re-establish irrigation flow prior to placing catheter in the body. Irrigated ablation systems have been shown to create larger lesions than standard radiofrequency ablation catheters. Be careful when ablating near electrically vulnerable, thin walled, or other arterial structures.
Potential Adverse Events: Potential adverse events include, but are not limited to, cardiovascular related complications, including hematoma, pericardial effusion and infection. More serious complications are rare, which can include damage to the heart or blood vessels; blood clots (which may lead to stroke); tamponade; severe pulmonary vein stenosis; heart block; myocardial infarction; esophageal fistula, or death.
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:
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)
MAT-2115646 v1.0
TACTIFLEX ABLATION CATHETER, SENSOR ENABLED
CAUTION: This product is intended for use by or under the direction of a physician. Prior to use, reference Instructions for Use, inside the product carton (when available) or at manuals.sjm.com or eifu.abbottvascular.com for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.
Indications: The TactiFlex™ Ablation Catheter, Sensor Enabled™ is indicated for use in cardiac electrophysiological mapping and for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation and concomitant atrial flutter, when used in conjunction with a compatible RF generator and three-dimensional mapping system.
Contraindications: Do not use for any of the following conditions: recent ventriculotomy or atriotomy heart surgery; prosthetic valves; active systemic infection; use in coronary vasculature; myxoma or intracardiac thrombus, transseptal approach with an interatrial baffle or patch; retrograde trans-aortic approach in patients with aortic valve replacement; patients unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation.
Warnings: The temperature data transmitted by the sensor in this catheter is representative of the irrigated electrode only and does not provide tissue temperature data. Application of RF energy on the left atrial posterior wall exceeding 40 W in power, or use of contact force ≥15g, increases the risk of esophageal perforating complications including atrio-esophageal fistula and death. Application of RF energy outside of the power and duration recommendations may increase the likelihood of steam pop occurrence. Patients undergoing septal accessory pathway ablation are at risk for complete AV block which requires the implantation of a permanent pacemaker. Implantable pacemakers and implantable cardioverter/defibrillator (ICDs) may be adversely affected by RF current. The combination of intracoronary placement of the ablation catheter and RF energy application has been associated with myocardial infarction and death. Inspect tubing, connections, and saline irrigation for air bubbles prior to and throughout its use in the procedure. Air or bubbles in the saline irrigation may cause emboli, potential injury, or fatality. Increased contact force may increase the risk for perforation during manipulation of the catheter. Contact force in excess of 20 g may not significantly change the characteristics of lesion formation. Contact force accuracy above 50 g has not been established. Caution should be taken when placing lesions in the proximity of the specialized conduction system. To avoid thromboemboli, intravenous heparin should be used when entering the left heart during ablation. Always maintain a constant saline irrigation flow to prevent coagulation within the lumen of the catheter. When using the catheter with conventional EP lab system (using fluoroscopy to determine catheter tip location) or with a 3D navigational system, careful catheter manipulation must be performed, especially when used in combination with a long sheath, in order to avoid cardiac damage, perforation, or tamponade.
Precautions: Always straighten the catheter tip before insertion or withdrawal. If irrigation flow is interrupted, immediately inspect and re flush the catheter outside of the patient. Re-establish irrigation flow prior to placing catheter in the body. Irrigated ablation systems have been shown to create larger lesions than standard radiofrequency ablation catheters. Be careful when ablating near electrically vulnerable, thin walled, or other arterial structures.
Potential Adverse Events: Potential adverse events include, but are not limited to, cardiovascular related complications, including hematoma, pericardial effusion and infection. More serious complications are rare, which can include damage to the heart or blood vessels; blood clots (which may lead to stroke); tamponade; severe pulmonary vein stenosis; heart block; myocardial infarction; esophageal fistula, or death.
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:
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)
MAT-2115646 v1.0
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