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It’s time for a better solution

Someday we will be able to predict heart failure events weeks before they happen.

Someday clinicians will be able to intervene earlier and help reduce patient hospitalizations.

Someday an actionable alert will help enable proactive care instead of reactive treatment.

That someday is today. With HeartLogic™ Heart Failure Diagnostic.*

*The HeartLogic Heart Failure Diagnostic is a validated diagnostic tool to detect gradual worsening of heart failure (HF) over days or weeks using multiple physiologic measurements.

 

Late-Breaking Clinical Trial Session

The HeartLogic Multi-sensor Algorithm Significantly Augments the
Prognosis of a Baseline NT-proBNP Assessment for Heart Failure Events

Presented by
John P. Boehmer, MD
Professor of Medicine, Penn State College of Medicine
Heart Failure Program Director, The Penn State Hershey Medical Center

The HeartLogic™ Heart Failure Diagnostic continues to impress, this time during a Late Breaking Clinical Trial session, presented by John P. Boehmer, MD.

  • New analysis of data from the MultiSENSE trial demonstrated HeartLogic significantly expanded the ability of a baseline blood test to identify when patients were at an elevated risk of a HF event3.
  • The combination of HeartLogic with a baseline NT-proBNP measurement identified over half of patient follow-up with a very low risk of experiencing a HF event (0.02 events/patient-year), compared against patients in an active HeartLogic alert who were at a 23 to 50 times increased risk of experiencing a HF event3.

Additional Boston Scientific abstract and clinical trial presentations at HFSA 2017

ABSTRACTS

Changes in Respiratory Rate, Third Heart Sound, and HeartLogic Identify Worsening Heart Failure in a Patient with no Decrease in Impedance
Heart Failure Diagnostics Sensor Measurements Change Prior to Heart Failure Decompensation Events
Night-time Elevation Angle in Heart Failure Patients Indicates Orthopnea and Paroxysmal Nocturnal Dyspnea
Ambulatory S3 Measured by an Implanted Device Changes Consistently with Echocardiography in Stable and Acute Decompensated Heart Failure
Third Heart Sound Measured by Implanted Accelerometer in Heart Failure Patients is Coincident with the Deceleration Phase of Early Diastolic Filling

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A promising step beyond current approaches, HeartLogic is a diagnostic tool that includes a composite index monitored over time and is designed to deliver proactive alerts of worsening heart failure to clinicians.
Multiple sensors track key physiological trends related to heart failure from within a high voltage Resonate™ family device.
HeartLogic combines these trends into one composite index.
Once the composite index crosses a programmable, clinician-set threshold, heart failure following clinicians are sent a proactive alert and given access to a detailed report. This is the information that your patient’s care team needs to know, before they’d expect to know it.
Multiple physiological sensors. One great choice for patients.

Our algorithm was designed to detect the early warning signs of worsening heart failure from a diverse set of sensors chosen to target the different aspects of heart failure pathology.

   

 
High Sensitivity.
Low alert burden.
Weeks of Advance Notice.
The published results of the MultiSENSE Study validated HeartLogic’s high sensitivity of 70% for predicting heart failure events with a very low burden of less than two total alerts per patient per year. In most cases, clinicians could have several weeks of advanced notice of a potential heart failure event.4 Based on the MultiSENSE performance data, we believe our proprietary service can offer your care team an unprecedented level of confidence for addressing heart failure events and the correlated costs.**
 

**The HeartLogic Index and Alert were validated using data from the MultiSENSE study; however, HeartLogic’s impact on clinical outcome has not been established. Establishment of the impact will require a post market trial designed specifically to study clinical outcomes directly related to the use of this feature.

The choice you make now could help your heart failure patients in the future.

Choosing to implant a high voltage Resonate™ family device is the first step in helping you move from reactive treatment to proactivecare for your patients with heart failure. Why wouldn’t you choose a device that is HeartLogic compatible?

CRT-D Systems –RESONATE™HF, RESONATE™, RESONATE™X4, VIGILANT™, VIGILANT™X4, MOMENTUM™, MOMENTUM™ X4

INDICATIONS AND USAGE

These Boston Scientific Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: Moderate to severe heart failure (NYHA Class III-IV) with EF ≤ 35% and QRS duration ≥ 120 ms; left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure

CONTRAINDICATIONS

There are no contraindications for this device.

WARNINGS

Read this manual thoroughly before implantation to avoid damage to the pulse generator and/or lead. For single patient use only. Do not reuse, reprocess, or resterilize. Always have external defibrillation equipment available during implant and electrophysiologic testing. Ensure that an external defibrillator and medical personnel skilled in CPR are present during post-implant device testing should the patient require external rescue. Do not use defibrillation patch leads with the pulse generator system. Do not use this pulse generator with another pulse generator. Program the pulse generator Tachy Mode(s) to Off during implant, explant, or postmortem procedures. Do not kink, twist, or braid the lead with other leads. For leads that require the use of a Connector Tool, use caution handling the lead terminal when the Connector Tool is not present on the lead. Do not directly contact the lead terminal with any surgical instruments or electrical connections such as PSA (alligator) clips, ECG connections, forceps, hemostats, and clamps. Do not contact any other portion of the DF4–LLHH or DF4–LLHO lead terminal, other than the terminal pin, even when the lead cap is in place. Do not contact any other portion of the IS4–LLLL lead terminal, other than the terminal pin, even when the lead cap is in place. When implant a system that uses both a DF4–LLHH or DF4–LLHO and IS4–LLLL lead, ensure that the leads are inserted and secured in the appropriate ports. Do not use atrial tracking modes in patients with chronic refractory atrial tachyarrhythmias. Do not use atrial-only modes in patients with heart failure. Left ventricular lead dislodgement to a position near the atria can result in atrial oversensing and left ventricular pacing inhibition. Physicians should use medical discretion when implanting this device in patients who present with slow VT. Advise patients to seek medical guidance before entering environments that could adversely affect the operation of the active implantable medical device, including areas protected by a warning notice that prevents entry by patients who have a pulse generator. RESONATE HF, RESONATE, and VIGILANT devices with an IS-1/DF4/IS4 lead connection are considered MR Conditional. For these devices, unless all of the MRI Conditions of Use are met, MRI scanning of the patient does not meet MR Conditional requirements for the implanted system, and significant harm to or death of the patient and/or damage to the implanted system may result. For potential adverse events applicable when the Conditions of Use are met or not met, refer to the MRI Technical Guide.. Do not subject a patient with an implanted pulse generator and/or lead to diathermy. If desired, ensure that Patient Triggered Monitor (PTM) is enabled prior to sending the patient home by confirming the magnet response is programmed to Store EGM. Once the PTM feature has been triggered and the magnet response set to Inhibit therapy the patient should not reapply the magnet.

PRECAUTIONS

For specific information on precautions, refer to the following sections of the product labeling: clinical considerations, sterilization and storage, implantation, device programming, environmental and medical therapy hazards, hospital and medical environments, home and occupational environments, follow-up testing, explant and disposal, supplemental precautionary information. Advise patients to avoid sources of EMI because EMI may cause the pulse generator to deliver inappropriate therapy or inhibit appropriate therapy.

POTENTIAL ADVERSE EVENTS

Potential adverse events include, but are not limited to, the following: allergic/physical/physiologic reaction, death, erosion/migration, fibrillation or other arrhythmias, lead or accessory breakage (fracture/insulation/lead tip), hematoma/seroma, inappropriate or inability to provide therapy (shocks /pacing/sensing), infection, procedure related, and component failure. Patients may develop psychological intolerance to a pulse generator system and may experience fear of shocking, fear of device failure, or imagined shocking. In rare cases severe complications or device failures can occur.

Refer to the product labeling for specific indications, contraindications, warnings/precautions and adverse events. Rx only.(Rev B)

ICD Systems – RESONATE™ HF, RESONATE™ EL, PERCIVA™ HF, PERCIVA™, VIGILANT™ EL, MOMENTUM™ EL

INDICATIONS AND USAGE

Boston Scientific implantable cardioverter defibrillators (ICDs) are intended to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

CONTRAINDICATIONS

Use of these Boston Scientific pulse generators are contraindicated for the following: patients whose ventricular tachyarrhythmias may have reversible cause, such as: digitalis intoxication, electrolyte imbalance, hypoxia, sepsis; or patients whose ventricular tachyarrhythmias have a transient cause, such as:  acute myocardial infarction (MI), electrocution, drowning; or patients who have a unipolar pacemaker.

WARNINGS

Read this manual thoroughly before implantation to avoid damage to the pulse generator and/or lead. For single patient use only. Do not reuse, reprocess, or resterilize. Always have external defibrillation equipment available during implant and electrophysiologic testing. Ensure that an external defibrillator and medical personnel skilled in CPR are present during post-implant device testing should the patient require external rescue. Do not use this pulse generator with another pulse generator. Program the pulse generator Tachy Mode(s) to Off during implant, explant, or postmortem procedures to avoid inadvertent high voltage shocks.  Do not kink, twist, or braid the lead with other leads as doing so could cause lead insulation abrasion damage or conductor damage. For leads that require the use of a Connector Tool, use caution handling the lead terminal when the Connector Tool is not present on the lead. Do not directly contact the lead terminal with any surgical instruments or electrical connections such as PSA (alligator) clips, ECG connections, forceps, hemostats, and clamps. Do not contact any other portion of the DF4–LLHH or DF4–LLHO lead terminal, other than the terminal pin, even when the lead cap is in place. Do not use atrial tracking modes in patients with chronic refractory atrial tachyarrhythmias. Tracking of atrial arrhythmias could result in ventricular tachyarrhythmias. Advise patients to seek medical guidance before entering environments that could adversely affect the operation of the active implantable medical device, including areas protected by a warning notice that prevents entry by patients who have a pulse generator. RESONATE HF, RESONATE, PERCIVA HF, PERCIVA, and VIGILANT devices with a DF4 right ventricular lead connection are considered MR Conditional. For these devices, unless all of the MRI Conditions of Use are met, MRI scanning of the patient does not meet MR Conditional requirements for the implanted system, and significant harm to or death of the patient and/or damage to the implanted system may result. For potential adverse events applicable when the Conditions of Use are met or not met, refer to the MRI Technical Guide. Do not subject a patient with an implanted pulse generator and/or lead to diathermy. If desired, ensure that Patient Triggered Monitor is enabled prior to sending the patient home. Once the Patient Triggered Monitor feature has been triggered by the magnet and an EGM has been stored, or after 60 days have elapsed from the day that Store EGM was enabled, the patient should not apply the magnet.

PRECAUTIONS

For specific information on precautions, refer to the following sections of the product labeling: clinical considerations, sterilization and storage, implantation, device programming, environmental and medical therapy hazards, hospital and medical environments, home and occupational environments, follow-up testing, explant and disposal, and supplemental precautionary information.

POTENTIAL ADVERSE EVENTS

Potential adverse events include, but are not limited to, the following: allergic/physical/physiologic reaction, death, erosion/migration, fibrillation or other arrhythmias, lead or accessory breakage (fracture/insulation/lead tip), hematoma/seroma, inappropriate or inability to provide therapy (shocks /pacing/sensing), infection, procedure related, and component failure. Patients may develop psychological intolerance to a pulse generator system and may experience fear of shocking, fear of device failure, or imagined shocking. In rare cases severe complications or device failures can occur.

Refer to the product labeling for specific indications, contraindications, warnings/precautions and adverse events. Rx only.(Rev B)

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