CARDIOVASCULAR
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We are excited to announce Abbott’s participation in the 26th Annual International AF Symposium on January 29-31, 2021! This intensive, three-day symposium brings together the world's leading medical scientists to share the most recent advances in the field of atrial fibrillation.

Abbott-Sponsored Scientific Session

Abbott will be sponsoring a scientific session on Friday, January 29, “Atrial Fibrillation in Patients with Heart Failure and Preserved Ejection Fraction." Register at the link below.


Moderator: Larry Chinitz, MD | Digital Moderator: Meleze Hocini, MD

Abbott EP Product Solutions for Atrial Fibrillation

Discover the Abbott products helping health care professionals in different scenarios and settings treat atrial fibrillation.

RSPV Live View

Abbott EP Solution in Paroxysmal AF

Case Description: This patient presented to the EP lab for a planned pulmonary vein isolation (PVI) procedure with roof line due to episodes of symptomatic paroxysmal atrial fibrillation (AF). An initial map and model of the left atrium was created using the Adviser™ HD Grid Mapping Catheter, Sensor Enabled™. PVI and roof line were completed using the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ and the EnSite™ AutoMark Module to help target a force measurement between 10 and 30 grams, and an impedance drop of greater than 10 ohms. This video shows continuation of AF in the right superior pulmonary vein (RSPV) following successful PVI. Synchronized cardioversion of the vein was attempted at 100 J with temporary success, but AF reinitiated within the isolated RSPV following a 12 mg bolus of adenosine. At that point, the Advisor HD Grid Mapping Catheter, SE and EnSite™ LiveView Dynamic Display software were used to target the site of earliest activation and consistent fractionation within the vein. Ablation at the EnSite LiveView Dynamic Display-suggested target site led to the termination of vein AF within 3 seconds.

Fast.1 Accurate.2 Easy to Use.3

The Advisor™ HD Grid Mapping Catheter, SE offers a high-density mapping catheter able to rapidly1 collect high-density electrograms to confirm acute PVI.

Advisor™ HD Grid Mapping Catheter, Sensor Enabled™

TactiCath Contact Force Ablation Catheter and Monitor Showing Cardiac Mapping

Accuracy Matters. See Things Differently

TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ is an innovative solution for the treatment of atrial fibrillation. It features advanced handle-shaft technology and full integration with Abbott’s EnSite Precision™ cardiac mapping system.

TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™

Cardiac Map Display of the EnSite Precision Cardiac Mapping System

Address Bipolar Blindness with Every Beat.

EnSite™ LiveView Dynamic Display lets you visualize mapping data in real time from the current location of Advisor™ HD Grid Mapping Catheter, Sensor Enabled™.

EnSite™ LiveView Dynamic Display

Perclose Proglide

Improve lab efficiency, same-day discharge and patient satisfaction.

With the broadest venous and arterial indication,4 Perclose ProGlide™ SMC System can be utilized for procedures requiring 5-24F (Max 29F OD5) venous sheaths and 5-21F (Max 26F OD5) arterial sheaths.

It supports your practice in offering immediate, durable hemostasis;6,7 expedited recovery time and reduced hospital costs.8

Perclose ProGlide™ Suture-Mediated Closure System

Capturing the rhythm of life

The Confirm Rx™ ICM with SharpSense™ technology gives you the information you need to clearly and confidently diagnose difficult to detect arrhythmias with fewer interruptions to patients’ daily lives.

Confirm Rx™ insertable cardiac monitor (ICM) with SharpSense™ technology

References

  1. Abbott. Report on file. 90299533.
  2. Abbott. Report on file. 90262900.
  3. Abbott. Report on file. 90355919.
  4. As compared to Angio-Seal, ExoSeal, Celt ACD, MANTA, Mynx, Vascade. Data on file at Abbott.
  5. Max. OD 26F/0.340 inches/8.62 mm; Max. OD 29F/0.378 inches/9.59 mm. Tests performed by and data on file at Abbott.
  6. U.S. Perclose ProGlide™ SMC System Instructions for Use.
  7. Kar, S., et al, The Use of Perclose ProGlide Suture-Mediated Closure (SMC) Device for Venous Access-Site Closure Up to 24F Sheaths. CRT 2018.
  8. Verma, S., et al, Feasibility and Safety of Same Day Discharge for Patients Undergoing Atrial Fibrillation (AF) Ablation in a Community Hospital Setting. HRS 2020 Science Online, May 2020.

Important Safety Warnings

Advisor™ HD Grid Mapping Catheter, Sensor Enabled

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Indications: The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. Contraindications: The catheter is contraindicated for patients with prosthetic valves and patients with left atrial thrombus or myxoma, or interatrial baffle or patch via transseptal approach. This device should not be used with patients with active systemic infections. The catheter is contraindicated in patients who cannot be anticoagulated or infused with heparinized saline.

Contraindications: Contraindicated for patients with prosthetic valves and patients with left atrial thrombus or myxoma, or interatrial baffle or patch via transseptal approach. This device should not be used with patients with active systemic infections. The catheter is contraindicated in patients who cannot be anticoagulated or infused with heparinized saline.

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 eifu.abbottvascular.com or at manuals.sjm.com for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

Warnings: Cardiac catheterization procedures present the potential for significant x-ray exposure, which can result in acute radiation injury as well as increased risk for somatic and genetic effects, to both patients and laboratory staff due to the x-ray beam intensity and duration of the fluoroscopic imaging. Careful consideration must therefore be given for the use of this catheter in pregnant women. Catheter entrapment within the heart or blood vessels is a possible complication of electrophysiology procedures. Vascular perforation or dissection is an inherent risk of any electrode placement. Careful catheter manipulation must be performed in order to avoid device component damage, thromboembolism, cerebrovascular accident, cardiac damage, perforation, pericardial effusion, or tamponade. Risks associated with electrical stimulation may include, but are not limited to, the induction of arrhythmias, such as atrial fibrillation (AF), ventricular tachycardia (VT) requiring cardioversion, and ventricular fibrillation (VF). Catheter materials are not compatible with magnetic resonance imaging (MRI).

Precautions: Maintain an activated clotting time (ACT) of greater than 300 seconds at all times during use of the catheter. This includes when the catheter is used in the right side of the heart. To prevent entanglement with concomitantly used catheters, use care when using the catheter in the proximity of the other catheters. Maintain constant irrigation to prevent coagulation on the distal paddle. Inspect irrigation tubing for obstructions, such as kinks and air bubbles. If irrigation is interrupted, remove the catheter from the patient and inspect the catheter. Ensure that the irrigation ports are patent and flush the catheter prior to re-insertion. Always straighten the catheter before insertion or withdrawal. Do not use if the catheter appears damaged, kinked, or if there is difficulty in deflecting the distal section to achieve the desired curve. Do not use if the catheter does not hold its curve and/or if any of the irrigation ports are blocked. Catheter advancement must be performed under fluoroscopic guidance to minimize the risk of cardiac damage, perforation, or tamponade.

TactiCath™ Ablation Catheter, Sensor Enabled

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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 TactiCath™ Ablation Catheter, Sensor Enabled™ is indicated for use in cardiac electrophysiological mapping and for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used in conjunction with a compatible RF generator and three-dimensional mapping system. Contraindications: Do not use for any of the following conditions: certain recent heart surgery; prosthetic valves; active systemic infection; use in coronary vasculature; myxoma or intracardiac thrombus, or an interatrial baffle or patch; retrograde trans-aortic approach in patients with aortic valve replacement.

Warnings: It is important to carefully titrate RF power; too high RF power during ablation may lead to perforation caused by steam pop. Contact force in excess of 70 g may not improve the characteristics of lesion formation and may increase the risk for perforation during manipulation of the catheter. 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 may be adversely affected by RF current. Always verify the tubing and catheter have been properly cleared of air prior to inserting the catheter into the vasculature since entrapped air can cause potential injury or fatality. The temperature data transmitted by the sensor in this catheter is representative of the irrigated electrode only and does not provide tissue temperature data.

Precautions: The long-term risks of protracted fluoroscopy and creation of RF induced lesions have not been established; careful consideration must be given for the use of the device in prepubescent children. When using the catheter with conventional EP lab system or with a 3-D navigational system, careful catheter manipulation must be performed, in order to avoid cardiac damage, perforation, or tamponade. Always maintain a constant saline irrigation flow to prevent coagulation within the lumen of the catheter. Care should be taken when ablating near structures such as the sino-atrial and AV nodes.

Potential Adverse Events: Potential adverse events include, but are not limited to, cardiovascular related complications, including groin 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 attack; esophageal fistula, or death.

Ensite™ LiveView Dynamic Display

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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 eifu.abbottvascular.com or at manuals.sjm.com for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

Indications: The EnSite Precision™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated. The EnSite Precision™ System interfaces to either the MediGuide™ Technology System or the EnSite Precision™ Module to combine and display magnetic processed patient positioning and navigation mapping information. When used with the EnSite™ Array™ Catheter, the EnSite Precision™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone. OR, when used with an EnSite Precision™ Surface Electrode Kit, the EnSite Precision™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.

Warnings: Refer to the ablation catheter labeling for a listing of adverse events related to the use of this device in conjunction with radio frequency ablation, as a part of the diagnosis and treatment of cardiac arrhythmias. For patient safety, any connections that directly connect the patient to the EnSite Precision Cardiac Mapping System must be routed through the appropriate module: EnSite Precision Link, Sensor Enabled™ NavLink, EnSite Precision Field Frame, ArrayLink, CathLink, SJM ECG Cable, RecordConnect, or GenConnect. When using the EnSite Precision Module full protection against the effects of cardiac defibrillator discharge and other leakage currents is dependent upon the use of appropriate cables. Refer to the ablation catheter labeling for a listing of adverse events related to the use of this device in conjunction with radio frequency ablation, as a part of the diagnosis and treatment of cardiac arrhythmias. For patient safety, any connections that directly connect the patient to the EnSite Precision Cardiac Mapping System must be routed through the appropriate module: EnSite Precision Link, Sensor Enabled™ NavLink, EnSite Precision Field Frame, ArrayLink, CathLink, SJM ECG Cable, RecordConnect, or GenConnect. When using the EnSite Precision Module full protection against the effects of cardiac defibrillator discharge and other leakage currents is dependent upon the use of appropriate cables.

Precautions: Do not operate the EnSite Precision Field Frame within 10 meters (m) of another operating Field Frame. Do not place the EnSite Precision Field Frame cable inside the measurement volume or wrap it around the Field Frame, as it may create a magnetic interference. Do not coil the EnSite Precision Field Frame cable. The cable carries enough electric current that a magnetic field will be created when the cable is placed in a circular formation. This magnetic field may disturb the Field Frame’s magnetic field. Do not place the EnSite Precision Link, Sensor Enabled™ within 1 m of the EnSite Precision Field Frame - Do not place tool cables within 30 millimeters (mm) of the EnSite Precision Field Frame cable. If placed this close—particularly if the cables are parallel to each other—the tool cable may become subject to electromagnetic interference. Metallic equipment used in close proximity to the magnetic field during the procedure, such as a sterile drape holder, may affect Sensor Enabled (SE) points and SE field scaling accuracy. Do not use the EnSite Precision Cardiac Mapping System in the presence of other magnetic fields. Do not drop the EnSite Precision Field Frame or subject it to impact. Physical damage to the Field Frame may alter the Field Frame’s factory calibration.

Perclose ProGlide™ SMC System

RxOnly

Indications: The Perclose ProGlide™ SMC System is indicated for the percutaneous delivery of suture for closing the common femoral artery and vein access site of patients who have undergone diagnostic or interventional catheterization procedures. The Perclose ProGlide™ SMC System is used without or, if required, with adjunctive manual compression. For access sites in the common femoral artery using 5F to 21F sheaths. For access sites in the common femoral vein using 5F to 24F sheaths. For arterial and venous sheath sizes greater than 8F, at least two devices and the pre-close technique are required.

Caution: Federal law restricts this device to sale by or on the order of a physician (or allied healthcare professionals, authorized by, or under the direction of, such physicians) who is trained in diagnostic and / or interventional catheterization procedures and who has been trained by an authorized representative of Abbott Vascular. Prior to use, the operator must review the Instructions for Use and be familiar with the deployment techniques associated with the use of this device. During closure of access sites using a procedural sheath greater than 8F it is recommended that a vascular surgeon or a surgeon with vascular training be available in case surgical conversion to control bleeding and to close the vessel is needed.

Contraindications: There are no known contraindications to the use of this device. Attention is drawn to the WARNINGS and PRECAUTIONS sections.

Warnings: Do not use the Perclose ProGlide™ SMC device or accessories if the packaging or sterile barrier has been previously opened or damaged or if the components appear to be damaged or defective. DO NOT RESTERILIZE OR REUSE. The Perclose ProGlide™ SMC device and accessories are intended for single use only. Do not use the Perclose ProGlide™ SMC System if the sterile field has been broken where bacterial contamination of the sheath or surrounding tissues may have occurred, since such a broken sterile field may result in infection. Do not use the Perclose ProGlide™ SMC System if the puncture site is located above the most inferior border of the inferior epigastric artery (IEA) and / or above the inguinal ligament based upon bony landmarks, since such a puncture site may result in a retroperitoneal hematoma. Perform a femoral angiogram to verify the location of the puncture site. NOTE: This may require both a Right Anterior Oblique (RAO) and Left Anterior Oblique (LAO) angiogram to adequately visualize where the sheath enters the femoral artery or vein. Do not use the Perclose ProGlide™ SMC System if the puncture is through the posterior wall or if there are multiple punctures, since such punctures may result in a hematoma or retroperitoneal bleed. Do not use the Perclose ProGlide™ SMC System if the puncture site is located in the superficial femoral artery or the profunda femoris artery, or the bifurcation of these vessels, since such puncture sites may result in a pseudoaneurysm, intimal dissection, or an acute vessel closure (thrombosis of small artery lumen). Perform a femoral angiogram to verify the location of the puncture site. NOTE: This may require both a Right Anterior Oblique (RAO) and Left Anterior Oblique (LAO) angiogram to adequately visualize where the sheath enters the femoral artery or vein.

Precautions: 1. Prior to use, inspect the Perclose ProGlide™ SMC System to ensure that the sterile packaging has not been damaged during shipment. Examine all components prior to use to verify proper function. Exercise care during device handling to reduce the possibility of accidental device breakage. 2. As with all catheter-based procedures, infection is a possibility. Observe sterile technique at all times when using the Perclose ProGlide™ SMC System. Employ appropriate groin management, as per hospital protocol, post procedure and post hospital discharge to prevent infection. 3. Use a single wall puncture technique. Do not puncture the posterior wall of the vessel. 4. Do not deploy the Perclose ProGlide™ SMC device at an angle greater than 45 degrees, as this may cause a cuff miss. 5. There are no reaccess restrictions if previous access site repairs were achieved with Abbott Vascular SMC devices. 6. If significant blood flow is present around the Perclose ProGlide™ SMC device, do not deploy needles. Remove the Perclose ProGlide™ SMC device over a 0.038" (0.97mm) (or smaller) guidewire and insert an appropriately sized introducer sheath. 7. When pushing the plunger assembly to advance the needles, stabilize the device to ensure the device does not twist or move forward during deployment. Twisting the device could lead to needle deflection resulting in a cuff miss. Do not use excessive force or repeatedly push the plunger assembly. Excessive force on the plunger during deployment could potentially cause breakage of the device, which may necessitate intervention and / or surgical removal of the device and vessel repair. 8. Do not apply excessive force to the lever when returning the foot to its original position (marked #4) down to the body of the device. Do not attempt to remove the device without closing the lever. Excessive force on the lever of the device or attempting to remove the device without closing the lever could cause breakage of the device and / or lead to vessel trauma, which may necessitate intervention and / or surgical removal of the device and vessel repair. 9. Do not advance or withdraw the Perclose ProGlide™ SMC device against resistance until the cause of that resistance has been determined (see Section 11.3 Single SMC DEVICE PLACEMENT section). Excessive force used to advance or torque the Perclose ProGlide™ SMC device should be avoided, as this may lead to significant vessel damage and / or breakage of the device, which may necessitate intervention and / or surgical removal of the device and vessel repair. 10. If excessive resistance in advancing the Perclose ProGlide™ SMC device is encountered, withdraw the device over a 0.038" (0.97 mm) (or smaller) guidewire and reinsert the introducer sheath or use manual compression. 11. Remove the Perclose ProGlide™ sheath before tightening the suture. Failure to remove the sheath prior to tightening the suture may result in detachment of the tip of the sheath. 12. During closure of access sites using a 5 – 8F procedural sheath, use manual compression in the event that bleeding from the femoral access site persists after the use of the Perclose ProGlide™ SMC device. 13. During closure of access sites using a procedural sheath > 8F, in the event that bleeding from the femoral access site persists after the use of the Perclose ProGlide™ SMC devices, the physician should assess the situation. Based on the physician assessment of the amount of bleeding use manual compression, compression assisted devices and / or a surgical repair to obtain hemostasis. 14. During closure of access sites using a procedural sheath > 8F, in those cases where the implanting physician is not a vascular surgeon, it is recommended that a vascular surgeon or a surgeon with vascular training be available during the procedure to perform any necessary surgical intervention.

Potential Adverse Events: Potential adverse events associated with use of suture mediated closure devices may include, but are not limited to, the following: Allergic reaction or hypersensitivity to device components, Anemia, Arterial stenosis / occlusion, Arteriovenous fistula, Bleeding / hemorrhage, Bruising / hematoma, Death, Deep vein thrombosis, Device entrapment, Device failure / malfunction / misplacement, Diminished pulses distal to closure site, Embolism, Hypotension / hypertension, Infection / sepsis, Inflammation, Intimal tear / dissection, Ischemia distal to closure site, Nerve injury, Numbness, Pain, Perforation, Pseudoaneurysm, Pulmonary embolism, Retroperitoneal hematoma / bleeding, Thrombus formation, Vascular injury, Vasoconstriction / vasospasm, Vasovagal episode, Wound dehiscence

Confirm Rx

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Indications: The Confirm Rx™ Insertable Cardiac Monitor (ICM) is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation. The Confirm Rx ICM has not been specifically tested for pediatric use.

Contraindications: There are no known contraindications for the insertion of the Confirm Rx ICM. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated.

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, contraindications, warnings, precautions and potential adverse events.

Additional information: Clinicians must log onto Merlin.net™ Patient Care Network (PCN) to view transmissions from patients’ Confirm Rx ICM. On Merlin.net PCN they can configure transmission schedules and enable or disable features on a patient’s myMerlin™ mobile app. Review of transmissions is dependent on the clinician and may not happen immediately following delivery of such transmissions.

Limitations: Patients may use their own Apple or Android mobile device to transmit information from their Confirm Rx ICM using the myMerlin mobile app. To do so the device must be powered on, app must be installed, Bluetooth® wireless technology enabled and data coverage (cellular or WiFi) available. The myMerlin mobile app provides periodic patient monitoring based on clinician configured settings. Data is resent if the transmission was not sent successfully. However, there are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of ICM and patient information as intended by the clinician. These factors include: patient environment, data services, mobile device operating system and settings, ICM memory capacity, clinic environment, schedule/configuration changes, or data processing. An Abbott mobile transmitter is available for patients without their own compatible mobile device.

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DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.