Technology | Implantable Cardioverter Defibrillator (ICD) | September 22, 2017

Abbott Secures FDA Approval for MRI Compatibility on Ellipse ICD

Approval adds to Abbott’s line of products designed to optimize treatment of abnormally fast heart rhythms

Abbott Secures FDA Approval for MRI Compatibility on Ellipse ICD

September 22, 2017 — Abbott announced U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labeling for one of the company's most widely-used implantable cardioverter defibrillators (ICD) and associated high voltage leads. The approval of MR-conditional labeling for the Ellipse ICD with the Tendril MRI pacing lead and Durata and Optisure high voltage leads adds another patient-centric benefit to the device and will help further improve access for patients suffering from abnormally fast heart rhythms who need an ICD and who may need an MRI scan in the future.

When electrical signals in the lower chamber of the heart fire erratically, the heart can beat abnormally fast – a condition known as ventricular tachycardia or tachyarrhythmia – which in turn leaves the heart unable to pump blood effectively. In addition to symptoms such as light-headedness, chest pains and shortness of breath, over time the condition can lead to a potentially life-threatening arrhythmia, heart failure, stroke or cardiac arrest. Abbott's ICD devices can monitor for and detect abnormally fast heart rhythms and deliver electricity to the heart to restore the heart's natural rhythm.

The new MR-conditional labeling for the Ellipse ICD allows patients to undergo an MRI scan if needed. In addition, patients previously implanted with an Ellipse device and Durata or Optisure leads can now undergo MRI scans.

The smaller shape and size of Ellipse ICD helps improve patient comfort once implanted, and Abbott engineered the device with features designed to optimize ICD therapy and improve patient safety. The features, known as Abbott's TailoredTherapy approach, include:

  • DeFT Response Technology: Allows physicians to adapt how therapy is delivered by the Ellipse ICD to ensure each patient receives therapy based on their unique need. The feature also helps ensure successful therapy delivery without the need to deliver an initial shock at the time of implant;
  • SecureSense: Abbott's SecureSense algorithm offers an additional level of protection for patients by providing proper sensing within the heart even in the presence of external interference (known as "lead noise") to safeguard against unnecessary therapy being delivered to the patient; and
  • DynamicTx: With Abbott's DynamicTx algorithm, physicians can be confident that their patient's devices are consistently evaluating the condition of the lead and adapting the path of the electrical impulse to deliver appropriate therapy.

 

As a further benefit, all therapy and other data captured by the Ellipse ICD can be directly, securely and wirelessly sent to a patient's physician through the Merlin.net Patient Care Network. This communication allows physicians to remotely monitor their patient's therapy and assess any need for intervention.

The latest labeling follows approval earlier this year of Abbott's Assurity MRI pacemaker and prior MR-conditional labeling approvals in Europe.

For more information: www.sjm.com

Related Content

Implicity provides a remote cardiac monitoring and research platform used by Independent Diagnostic Testing Facilities and medical centers to deliver high-quality care for patients with connected cardiac devices. On this platform, Implicity aggregates, normalizes and standardizes data from any implantable cardiac device across all manufacturers.

Implicity provides a remote cardiac monitoring and research platform used by Independent Diagnostic Testing Facilities and medical centers to deliver high-quality care for patients with connected cardiac devices. On this platform, Implicity aggregates, normalizes and standardizes data from any implantable cardiac device across all manufacturers.

News | EP Lab | June 02, 2021
June 2, 2021 — Implicity, a leader in remote patient monitoring software and cardiac data management solutions, annou
Left, the AcQCross Transseptal Crossing Device offers versatility to be utilized with top sheaths currently used in left atrium EP and structural heart procedures. Right, the AcQMap next-generation mapping catheter integrates high-resolution ultrasound-based imaging and non-contact mapping catheter with improved torque response, handling and maneuverability.

Left, the AcQCross Transseptal Crossing Device offers versatility to be utilized with top sheaths currently used in left atrium EP and structural heart procedures. Right, the AcQMap next-generation mapping catheter integrates high-resolution ultrasound-based imaging and non-contact mapping catheter with improved torque response, handling and maneuverability.

News | EP Lab | May 25, 2021
May 25, 2021 — Acutus Medical Inc.
Etripamil nasal spray was shown in a post-hoc analysis to resolve paroxysmal supraventricular tachycardia faster and more completely than placebo in most patients and reduced the number of emergency room visits for additional interventions. 

Etripamil nasal spray was shown in a post-hoc analysis to resolve paroxysmal supraventricular tachycardia faster and more completely than placebo in most patients and reduced the number of emergency room visits for additional interventions. 

Feature | EP Lab | May 16, 2021 | By Dave Fornell, Editor
May 16, 2020 — New data from in the ...
A device programmer showing the suspension of ICD therapies (orange bar, red arrow) with iPhone 12 laying over patient’s chest (green arrow) and fluoroscopy of iPhone 12 showing the circular magnet array (yellow arrow). Image from a small study at Henry Ford Hospital. Read the full study

A device programmer showing the suspension of ICD therapies (orange bar, red arrow) with iPhone 12 laying over patient’s chest (green arrow) and fluoroscopy of iPhone 12 showing the circular magnet array (yellow arrow). Image from a small study at Henry Ford Hospital. Read the full study

News | EP Lab | May 14, 2021
May 14, 2021 — The U.S.
Abbott Recalls Assurity and Endurity Pacemakers 
News | EP Lab | May 14, 2021
May 14, 2021 — Abbott is recalling a subset of Assurity and Endurity...
EP lab at the University of Colorado
News | EP Lab | May 12, 2021
May 12, 2021 — Galaxy Medical and Japan Lifeline announced an exclusive distribution agreement for the Alpha1 ablatio
The Bluegrass Vascular Surfacer System is designed to reliably, efficiently and repeatedly gain central venous access by inserting the Surfacer System through the right femoral vein and navigating it up through the patient’s venous system with an exit point in the right internal jugular vein, the optimal location for placing a central venous catheter. 

The Surfacer System is designed to reliably, efficiently and repeatedly gain central venous access by inserting the Surfacer System through the right femoral vein and navigating it up through the patient’s venous system with an exit point in the right internal jugular vein, the optimal location for placing a central venous catheter. 

News | EP Lab | May 06, 2021
May 6, 2021 - Bluegrass Vascular Technologies announced the publication of a report documenting the clinical utility
Patients receiving an implantable cardioverter defibrillator (ICD) should be regularly screened for anxiety and depression, according to research presented at European Heart Rhythm Association (EHRA) 2021 conference. ICD depression
News | EP Lab | April 26, 2021
April 26, 2021 — Patients receiving an implantable cardioverter defibrillator (ICD) should be regularly screened for
Former Vice President Mike Pence. Photo by Airman 1st Class Aubree Owens, 30th Space Wing Public Affairs

Photo by Airman 1st Class Aubree Owens, 30th Space Wing Public Affairs

News | EP Lab | April 19, 2021
April 19, 2021 — Former Vice President Mike Pence is recovering after having a...