Intended Use: Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices are intended to provide ventricular antitachycardia pacing and ventricular cardioversion/defibrillation. CRT-D devices are also intended to resynchronize the right and left ventricles.

Indications: CRT-D devices are indicated for the automated treatment of life-threatening ventricular arrhythmias. CRT-D devices are also indicated for treating symptoms in patients with congestive heart failure with ventricular dyssynchrony.

In addition, CRT-D devices with the AT/AF detection algorithm are indicated for patients with atrial tachyarrhythmias or patients at significant risk of developing atrial tachyarrhythmias.

MR Conditional CRT-Ds are conditionally safe for use in the MRI environment when used in a complete MR Conditional system and according to the instructions in the MRI-Ready Systems manual. Scanning under different conditions can result in serious patient injury, death, or device failure.

Contraindications: Contraindications to the use of the pulse generator system include ventricular tachyarrhythmias caused by transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction.

Entrant HF Cardiac Resynchronization Therapy Defibrillator (CRT-D) yazısı ilk önce Aventin Health üzerinde ortaya çıktı.

Kullanım Amacı: Kardiyak Resenkronizasyon Tedavisi Defibrilatörü (CRT-D) cihazlarının ventriküler antitaşikardi pacing ve ventriküler kardiyoversiyon/defibrilasyon sağlaması amaçlanmıştır. CRT-D devices are also intended to resynchronize the right and left ventricles.

Indications: CRT-D devices are indicated for the automated treatment of life-threatening ventricular arrhythmias. CRT-D devices are also indicated for treating symptoms in patients with congestive heart failure with ventricular dyssynchrony.

In addition, CRT-D devices with the AT/AF detection algorithm are indicated for patients with atrial tachyarrhythmias or patients at significant risk of developing atrial tachyarrhythmias.

MR Conditional CRT-Ds are conditionally safe for use in the MRI environment when used in a complete MR Conditional system and according to the instructions in the MRI-Ready Systems manual. Scanning under different conditions can result in serious patient injury, death, or device failure.

Contraindications: Contraindications to the use of the pulse generator system include ventricular tachyarrhythmias caused by transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction.

Gallant HF Cardiac Resynchronization Therapy Defibrillator (CRT-D) yazısı ilk önce Aventin Health üzerinde ortaya çıktı.

• Depolarization pattern
• Engagement of areas around scar tissue
• Hemodynamics
• Resync

Using the Quadra Allure MP CRT-P with the Quartet™ quadripolar LV pacing lead with four pacing electrodes and 14 pacing vectors provides more choice and more control over the CRT response.

US IDE STUDY: THE IMPORTANCE OF MPP™ TECHNOLOGY PROGRAMMING

The most recent IDE study1 post-hoc subanalysis (n = 199) showed that wider cathode spacing and nearly simultaneous intraventricular timing delays provided the best MPP technology response in 87 percent and a “super-response” in 54 percent (52 patients).

See details of the US IDE study and other clinical support for MultiPoint Pacing.

ADDITIONAL INTERNATIONAL CLINICAL DATA

This evidence is based on our quadrupole standard of care giving you more options for stepping up in the preferred LV region and has resulted in the following results:

• Improved CRT result
• Fewer surgical revisions
• Reduced need for lead repositioning at the implant results in shorter procedure times and reduced fluoroscopic exposure
• More baseline pacing opportunities without sacrificing lead stability

QUADRA ALLURE MP CRT-P ADVANCED FEATURES AND BENEFITS

Designed to Optimize Tissue Selection

Quadra Allure MP CRT-P offers the Auto VectSelect Quartet™ Test as:

• Automatically identifies tissue regions with latest activation via RV-LV conduction delay measurements
• Performs threshold testing, evaluates applicability of LVCap™ Validation and allows flagging of PNS

Pacing at the tissue site of the most recent activation improves:

• acute hemodynamic response
• Reverse remodeling
• Life quality

Advanced Programming Options

• SyncAV™ CRT technology automatically adjusts pacing based on real-time changes in the patient’s heart condition.

Providing Insightful Diagnostics and RF Monitoring

The Quadra Allure MP CRT-P helps you better manage your patients’ heart failure with intuitive programming options and provides timely access to vital heart failure diagnostic data via radio frequency (RF) monitoring and provides:

• CorVue™ congestion monitoring for an earlier insight into HF progression
• Daily remote monitoring of AT/AF alerts for changes in patient’s AF status
• DirectTrend™ reports for a simplified view of all device data

COMPREHENSIVE HEART FAILURE MANAGEMENT

Quadra Allure MP™ CRT-P is one of our heart failure management treatments. Our vision is to transform heart failure treatment by designing technology that delivers excellent clinical results and improves workflow and efficiency.

Quadra Allure MP™ Cardiac Resynchronization Therapy Pacemaker (CRT-P) yazısı ilk önce Aventin Health üzerinde ortaya çıktı.

• Depolarization pattern
• Engagement of areas around scar tissue
• hemodynamics
• resync

Featuring a Quartet™ quadripolar LV pacing lead with four pacing electrodes and 10 pacing vectors, the Quadra Assura MP™ CRT-D provides more choice and more control over CRT response.

US IDE STUDY: THE IMPORTANCE OF MULTIPOINT™ PACING TECHNOLOGY PROGRAMMING

The most recent IDE study post-hoc subanalysis (n = 199) showed that wider cathode spacing and nearly simultaneous intraventricular timing delays provided the best MultiPoint Pacing technology response at 87 percent and a “super response” at 54 percent (52 patients). .

Learn more:

• Read the full article on the US MultiPoint™ Pacing IDE study.
• Visit our clinical evidence for MultiPoint Pacing.

Additional International Clinical Data

This evidence is based on our quadrupole standard of care giving you more options for stepping up in the preferred LV region and has resulted in the following results:

• Improved CRT result
• Fewer surgical revisions
• Reduced need for lead repositioning at the implant results in shorter procedure times and reduced fluoroscopic exposure
• More baseline pacing opportunities without sacrificing lead stability

QUADRA ASSURA MP CRT-D ADVANCED FEATURES AND BENEFITS

MRI Ready Now

The Quadra Assura MP CRT-D is MR conditional when used with specific leads and lead lengths and allows full body, 1.5T MRI scans that meet specific scan conditions.*

• Meets industry standard MRI testing requirements
• Can do full body 1.5T MRI imaging scans

Designed to Optimize Texture Selection

Quadra Assura MP RF CRT-D offers the Auto VectSelect Quartet™ Test as:

• Automatically identifies tissue regions with latest activation via RV-LV conduction delay measurements
• Performs threshold testing, evaluates LVCap™, confirms applicability, and flags PNS

Pacing at the tissue site of the most recent activation improves:

• acute hemodynamic response
• Reverse remodeling
• Life quality

Advanced Programming Options

• SyncAV™ CRT technology automatically adjusts pacing based on real-time changes in the patient’s heart condition.
• Antitachycardia pacing (ATP) during charging and before charging in the VF region further expands programming options to terminate tachyarrhythmias without high voltage shock.
• The SenseAbility™ feature provides flexibility to fine-tune programming around T-wave oversensing without reducing sensitivity.

Additional Monitoring and Security Features

• ShockGuard™ technology with DecisionTx™ programming
• SecureSense™ RV lead noise discrimination
• Far Field MD™ morphology discrimination
• DeFT Response™ technology
• CorVue™ congestion monitoring
• QuickOpt™ timing loop optimization

Quadra Assura MP™ Cardiac Resynchronization Therapy Defibrillator (CRT-D) yazısı ilk önce Aventin Health üzerinde ortaya çıktı.

The Leaded Agilis HisPro™ steerable catheter is a rotatable, cleavable catheter with two distal tip electrodes for delivery of cardiac leads to the targeted anatomy. To facilitate insertion of the tip in a desired position in the heart, when fully bent, the distal portion can be formed into a “U” shape.

Lead electrodes provide the ability to detect intracardiac electrograms (EGM) and rate when connected to the WorkMate Claris™ Recording System or Merlin™ Pacing System Analyzer (PSA).

Redefining the Lead Delivery Experience with Groundbreaking Design

Pacing patients is an evolving practice and tools must evolve to meet the changing needs of both your practice and your patients. More and more implant specialists are considering non-traditional options for ventricular activation in certain patients.

We designed the Agilis HisPro catheter to simplify pacing procedures, enabling you to target the exact anatomy with greater control, precision, and repeatability.

Technology You Can Trust to Easily Find the Exact Cardiac Anatomy

By design, the leaded Agilis HisPro™ steerable catheter includes technology you can trust to target the exact cardiac anatomy.

Features and Key Features

• OD: 10.5 F, ID: 7.0 F
• Use with a minimum 10.5 F handle
• Catheter designed for delivery of the 6F lead
• The working length of the catheter is 38 cm.
• Requires a tip length of at least 58 cm

1. Integrated bipolar lead electrodes
2. Double declination and curve
3. 180° deflection control knob
4. Integrated split core and duct

 

Integrated Distal Tip Electrodes

Currently, no other lead delivery catheter is capable of sensing cardiac signals or accelerating tissue to allow for more accurate targeting and a simplified workflow. Narrow pitch bipolar electrodes at the tip of the Agilis HisPro catheter provide high-quality, near-field signals.

• “Split ring” electrode design
• Two 3×3 mm platinum iridium electrodes
• 180° apart from each other
• The catheter can accelerate and detect

Double Deflection and Unique Curve

The controlled deflection of the Agilis HisPro catheter lets you consistently reach specific locations. Its unique curved design enables a pacing lead to be easily oriented to the septum, if desired. Additionally, significant support within the catheter facilitates stable lead fixation.

• Designed to achieve at least 180° deflection with two ~90° bends
• PEBAX braided shank with varying stiffness along the shaft

One-Handed Control Knob for 180° Deflection

The ergonomic handle of the Agilis HisPro catheter provides one-handed control for single operator use. One-way button facilitates precise mm-to-mm movements to target the exact position for lead fixation.

• Unidirectional, 180° rotation
• Tactile markings indicate “home” and 180° position

Integrated Slittable Hub and Channel

The integrated cleavable hub and channel of the Agilis HisPro catheter, with its integrated hemostasis valve, increase procedural efficiency. Its molded core provides a smooth transition from the handle to the catheter shaft during slitting. Internal rails guide the cutter down the catheter and between the electrodes for added stability and a clean exit.

• Integrated hemostasis valve in the navel
• Slitting guide rails built into the spindle

Agilis HisPro™ | Lead Steerable Catheter yazısı ilk önce Aventin Health üzerinde ortaya çıktı.

The myMerlin™ mobile app accompanies Abbott’s Bluetooth®-enabled wearable cardiac monitors. The app is compatible with your patient’s iPhone‡ or Android‡ smartphone.* When paired with an attached Abbott ICM, the myMerlin mobile app provides data 20 times faster than other ICMs, making it easy, effective and confidential to monitor your patient’s heart.

myMerlin™ Mobile app yazısı ilk önce Aventin Health üzerinde ortaya çıktı.

Merlin.net™ Patient Care Network (PCN) is a remote monitoring system that imports and manages cardiac information for patients with Abbott implanted devices. The system allows you and other clinicians to upload and manage patient device data via a web interface. All you need is an Internet connection and a compatible browser.

Merlin.net™ Patient Care Network (PCN) yazısı ilk önce Aventin Health üzerinde ortaya çıktı.

The myMerlinPulse™ mobile app accompanies Abbott — Gallant™ and Entrant™’s latest Bluetooth® enabled ICD and CRT-D. The app is compatible with your patient’s iPhone‡ or Android‡ smartphone.* When paired with your patient’s implanted Gallant or Entrant devices, the app empowers you and your patient with a mobile solution that encourages continuous and reliable interaction with remote monitoring.

Check Connection Status

to make sure their devices are properly monitored

 

Submit Data Manually

as instructed by a clinician

 

Accessing Device Status

to check battery status and device model

 

View History

scheduled data transfers, connection issues, and patient notifications

 

Find Support

resources such as clinical information, technical support numbers, and FAQs

myMerlinPulse™ Mobile App yazısı ilk önce Aventin Health üzerinde ortaya çıktı.

Merlin@home™ Transmitter yazısı ilk önce Aventin Health üzerinde ortaya çıktı.

MerlinOnDemand™ Capability yazısı ilk önce Aventin Health üzerinde ortaya çıktı.