Improving Heart Health with Innovation

A healthy heart is a pumping machine. But when it’s not working properly, it can slow you down. Our science can help.

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Healthy Heart | Dec. 15, 2017

Your heart looks nothing like an emoji. It's not bright red and shiny. It doesn't have two humps. And it does much more than sparkle and cover the front of Valentines Day cards.

Your heart is a muscle — about the size of your fist — that works hard to move blood around your body to provide you with oxygen and nutrients. The blood flow also carries away waste.

When your heart is healthy, it is one mean, lean, pumping machine. But when your heart is not working properly, it can slow you down and harm your health. That's where science can help. Here's how.

Drumming the Right Beat

If a heartbeat is too slow or too fast, a doctor may recommend a pacemaker, a small battery-operated device that helps your heat beat in a regular rhythm, according to the American Heart Association (AHA). It helps improve heart health and enables people with abnormal heartbeats to live normal lives. Here's a rundown of how a pacemaker works, as explained by the AHA:

  • A pacemaker consists of wires and the small generator, which runs on a battery.
  • A surgeon implants the generator under skin through a small incision.
  • The wires, or leads, connect the generator to the heart.
  • The generator sends electrical impulses through the wires to stimulate your heart to beat.
  • The impulses are timed to flow at regular intervals.

Early Innovation

The pacemaker was invented by happy accident.

According to The Washington Post, Wilson Greatbatch, an assistant professor of electrical engineering at the University of Buffalo, was building equipment to monitor heart sounds back in 1956. He mistakenly placed a powerful transistor into an instrument, and the combination produced an electrical pulse similar to the rhythm of a human heart. Greatbatch realized the device could help the human heart beat and — eureka! — the first pacemaker.

Today's Pacemaker Progress

Pacemakers have come a long way since Greatbatch's discovery. Over the years, scientific innovation has allowed the medical device to become smaller and smarter.

Abbott's breakthrough pacemaker, for example, called the Assurity MRI™ pacemaker, is now the world's smallest, longest-lasting, wireless MRI-compatible pacemaker.

The Assurity MRI pacemaker was recently approved for magnetic resonance-conditional labeling by the U.S. Food and Drug Administration. The groundbreaking pacemaker includes wireless remote monitoring that allows doctors to access the user's diagnostic data and daily device measurements. This information helps doctors monitor and track a person's heart.

Stronger with Stents

A stent is a small tube inserted in an artery. Stents are generally made of metal mesh or sometimes fabric. Fabric stents, called stent grafts, are usually inserted in large arteries. If you have a weak artery, a doctor may place a stent inside to improve blood flow and stop the weakened arteries from bursting.

Think of scaffolding that helps support a building or bridge that's undergoing construction or repair. Like scaffolding, stents help keep weak arteries from falling down, and they strengthen the structure of your heart.

Cutting edge advancements have been made around stents in recent years. Abbott's XIENCE Everolimus Eluting Coronary Stent System, for example, provides mechanical support to a person's artery while a drug called everolimus is slowly released into the artery wall around the stent. The release of everolimus helps limit the overgrowth of tissue within the coronary stent.

While stents and pacemakers have advanced by leaps and bounds over the years, there are still more scientific developments to be made around the heart-aiding devices. That's why the interest and brain power of young scientists is so important. People just like you can easily become the next Wilson Greatbatch with a little curiosity and a whole lot of cool science!

IMPORTANT SAFETY INFORMATION

XIENCE Everolimus Eluting Coronary Stent System
Assurity MRI™

Dual-Chamber Pacemaker

BRIEF SUMMARY:

Prior to using these devices, please review the User's Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

INDICATIONS:

Implantation is indicated in one or more of the following permanent conditions: syncope, presyncope, fatigue, disorientation due to arrhythmia/bradycardia or any combination of those symptoms. 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 those 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 A-V block or sinus arrest, chronic atrial fibrillation, severe physical disability. AF Suppression™ algorithm is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications.

CONTRAINDICATIONS:

Dual-chamber pulse generators are contraindicated in patients with an implanted cardioverter-defibrillator. Rate-Adaptive Pacing may be inappropriate for patients who experience angina or other symptoms of myocardial dysfunction at higher sensor-driven rates. An appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation rate tolerated by the patient.

AF Suppression™ stimulation is not recommended in patients who cannot tolerate high atrial-rate stimulation. Dual-Chamber Pacing, though not contraindicated for patients with chronic atrial flutter, chronic atrial fibrillation, or silent atria, may provide no benefit beyond that of single-chamber pacing in such patients. 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. Single-Chamber Atrial Pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction.

POTENTIALS ADVERSE EVENTS:

The following are potential complications associated with the use of any pacing system: arrhythmia, heart block, thrombosis, threshold elevation, valve damage, pneumothorax, myopotential sensing, vessel damage, air embolism, body rejection phenomena, cardiac tamponade or perforation, formation of fibrotic tissue/local tissue reaction, inability to interrogate or program a device because of programmer malfunction, infection, interruption of desired device function due to electrical interference, loss of desired pacing and/or sensing due to lead displacement, body reaction at electrode interface or lead malfunction (fracture or damage to insulation), loss of normal device function due to battery failure or component malfunction, device migration, pocket erosion or hematoma, pectoral muscle stimulation, phrenic nerve or diaphragmatic stimulation. The following, in addition to the above, are potential complications associated with the use of rate-modulated pacing systems: inappropriate, rapid pacing rates due to sensor failure or to the detection of signals other than patient activity, loss of activity-response due to sensor failure, palpitations with high-rate pacing.

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

XIENCE Everolimus Eluting Coronary Stent System

The XIENCE V®, XIENCE nano®, XIENCE PRIME®, XIENCE PRIME® LL, XIENCE Xpedition®, XIENCE Xpedition® SV and XIENCE Xpedition® LL , XIENCE Alpine®, and XIENCE SierraTM (XIENCE Family) of Everolimus Eluting Coronary Stents on the MULTI-LINK VISION® or MULTI-LINK MINI VISION® Delivery System

INDICATIONS

The XIENCE Sierra stent system is indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32 mm) with reference vessel diameters of ≥ 2.25 mm to ≤ 4.25 mm. In addition, the XIENCE Sierra stent system is indicated for treating de novo chronic total coronary occlusions.

CONTRAINDICATIONS

The XIENCE Sierra stent system is contraindicated for use in:

Patients who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or the post-procedural antiplatelet regimen.

Patients with hypersensitivity or contraindication to everolimus or structurally related compounds, or known hypersensitivity to stent components (cobalt, chromium, nickel, tungsten, acrylic, fluoropolymers), or with contrast sensitivity.

WARNINGS

It is not recommended to treat patients having a lesion that prevent complete inflation of an angioplasty balloon.

Judicious patient selection is necessary because the use of this device carries the associated risk of stent thrombosis, vascular complications, and/or bleeding events.

This product should not be used in patients who are not likely to comply with the recommended antiplatelet therapy.

PRECAUTIONS

Ensure that the inner package sterile barrier has not been opened or damaged prior to use.

Stent implantation should only be performed by physicians who have received appropriate training.

Stent placement should be performed at hospitals where emergency coronary artery bypass graft surgery (CABG) is accessible.

Subsequent restenosis may require repeat dilatation of the arterial segment containing the stent. Long-term outcomes following repeat dilatation of the stent are presently unknown.

Care should be taken to control the guiding catheter tip during stent delivery, deployment and balloon withdrawal. Before withdrawing the stent delivery system, visually confirm complete balloon deflation by fluoroscopy to avoid guiding catheter movement into the vessel and subsequent arterial damage.

When DES are used outside the specified Indications for Use, patient outcomes may differ from the results observed in the SPIRIT family of trials.

Compared to use within the specified Indications for Use, the use of DES in patients and lesions outside of the labeled indications may have an increased risk of adverse events, including stent thrombosis, stent embolization, MI, or death.

Orally administered everolimus combined with cyclosporine is associated with increased serum cholesterol and triglycerides levels.

A patient’s exposure to drug and polymer is proportional to the number and total length of implanted stents. See Instructions for Use for current data on multiple stent implantation.

Safety and effectiveness of the XIENCE Family of stents have not been established for subject populations with the following clinical settings:

Patients with prior brachytherapy of the target lesion or the use of brachytherapy for treated site restenosis, patients in whom mechanical atherectomy devices or laser angioplasty catheters are used in conjunction with XIENCE Family stents, women who are pregnant or lactating, men intending to father children, pediatric patients, unresolved vessel thrombus at the lesion site, coronary artery reference vessel diameters < 2.25 mm or > 4.25 mm or lesion length > 32 mm, lesions located in saphenous vein grafts, unprotected left main coronary artery, ostial lesions, lesions located at a bifurcation or previously stented lesions, diffuse disease or poor flow (TIMI < 1) distal to the identified lesions, excessive tortuosity proximal to or within the lesion, recent Acute Myocardial Infarction (AMI) or evidence of thrombus in target vessel, multivessel disease, and in-stent restenosis.

Everolimus has been shown to reduce the clearance of some prescription medications when administered orally along with cyclosporine (CsA). Formal drug interaction studies have not been performed with the XIENCE Family of stents because of limited systemic exposure to everolimus eluted from the stent.

Everolimus is an immunosuppressive agent. Consideration should be given to patients taking other immunosuppressive agents or who are at risk for immune suppression.

Oral everolimus use in renal transplant patients and advanced renal cell carcinoma patients was associated with increased serum cholesterol and triglycerides, which in some cases required treatment.

Non-clinical testing has demonstrated that the XIENCE Sierra stent, in single and in overlapped configurations up to 71 mm in length, is MR Conditional. It can be scanned safely under the conditions in the Instructions for Use.

The XIENCE Family of stents should be handled, placed, implanted, and removed according to the Instructions for Use.

POTENTIAL ADVERSE EVENTS

Adverse events (in alphabetical order) which may be associated with percutaneous coronary intervention treatment procedures and the use of a coronary stent in native coronary arteries include, but are not limited to, the following:

Abrupt closure, hematoma, or hemorrhage, Acute myocardial infarction, Allergic reaction or hypersensitivity to latex, contrast agent, anesthesia, device materials (platinum, polymer, cobalt, chromium, nickel, tungsten, acrylic, fluoropolymers), and drug reactions to everolimus, anticoagulation, or antiplatelet drugs, Arterial rupture, Arteriovenous fistula, Arrhythmias, atrial and ventricular, Bleeding complications, which may require transfusion, Cardiac tamponade, Coronary artery spasm, Coronary or stent embolism, Coronary or stent thrombosis, Death, Dissection of the coronary artery, Fever, Hypotension and/or hypertension, Ischemia (myocardial), Myocardial infarction (MI), Nausea and vomiting, Palpitations, Peripheral ischemia, Pseudoaneurysm, Renal Failure, Restenosis, Shock/pulmonary edema, Stroke/cerebrovascular accident (CVA), Total occlusion of coronary artery, Unstable or stable angina pectoris, Vascular access complications which may require vessel repair, Vessel dissection

The risks described below include, but are not limited to, the anticipated adverse events relevant for the cardiac population referenced in the contraindications, warnings, and precautions sections of the everolimus labels.

Abdominal pain; Anemia; Angioedema; Constipation; Cough; Diarrhea; Dyslipidemia (including hyperlipidemia and hypercholesterolemia); Dyspnea; Edema (peripheral); Headache; Hyperglycemia; Hypertension; Hypokalemia; Elevations of serum creatinine; Infections: bacterial, viral, fungal, and protozoan infections (may include opportunistic infections); Lymphoma and skin cancer; Male infertility; Oral ulcerations; Nausea; Non-infectious pneumonitis; Pain; Proteinuria; Pyrexia; Rash; Thrombotic microangiopathy (TMA)/Thrombotic thrombocytopenic purpura (TTP)/Hemolytic uremic syndrome (HUS); Urinary tract infection; Upper respiratory tract infection; Vomiting

Live vaccines should be avoided and close contact with those that have had live vaccines should be avoided. Fetal harm can occur when administered to a pregnant woman. There may be other potential adverse events that are unforeseen at this time.