Technology | Implantable Cardioverter Defibrillator (ICD) | December 22, 2015

FDA Approves Biotronik Iperia ICD Systems with Full-Body ProMRI Technology

Iperia series of ICDs and leads allow range of patient access to MRI
 

December 22, 2015 — Biotronik received U.S. Food and Drug Administration (FDA) approval for use of its latest family of implantable cardioverter defibrillator (ICD) systems with magnetic resonance imaging (MRI) scans. Biotronik ProMRI technology allows patients with approved device systems to have 1.5 Tesla MRI scans without an exclusion zone. ICD patients will have expanded access to MRI diagnostic scans, which can be critical for diagnosing conditions such as stroke, brain and cardiac tumors or orthopedic injuries.
 
The Biotronik ProMRI ICD family approval includes the Iperia DR-T in both DF-1 and DF4 configurations; and the Iperia DX System, the only ICD hybrid that combines the benefits of both single- and dual-chamber devices.
 
Also included is Inventra ProMRI DX, which is the only ICD available that offers ultra-high energy (42 Joules) on the first shock, for patients with complex heart conditions who may require a higher-powered first shock for effective therapy. The devices are MR conditional when used with appropriate Biotronik leads to complete the approved ProMRI system.
 
MRI scans are used to diagnose a multitude of conditions, especially those involving “soft” tissue like heart, brain, muscles and liver. Seventy-five percent of patients with an implantable electronic device (pacemaker or ICD) will need an MRI in their lifetime.[1]  Until recently, people with ICDs were denied access to MRIs. Biotronik is one of the first companies in the United States with ICDs that allow this access, following the first FDA approval in September 2015.
 
“We have truly entered a new era of total health care for cardiac rhythm management patients who rely on ICDs to monitor their hearts and provide life-saving therapy when demanded,” said Mark A. Marieb, M.D., clinical director of electrophysiology at Yale-New Haven Hospital and Yale School of Medicine in New Haven, Conn., and an investigator in the ProMRI Clinical Study.
“Devices that are tested to be safe and approved by the FDA for use in MRI scans provide assurance to patients and all of their current and future healthcare providers that this therapy will not create a compromise for other diagnostic needs in the patients’ lifetimes.” 

In addition to ProMRI technology, the newly approved devices include other features unique to Biotronik devices:

•        Closed Loop Stimulation (CLS), Biotronik’s proprietary rate response algorithm that allows patients to receive the most physiologic pacing adaptation in accordance with their metabolic needs.

•        DX technology is based on more than a decade of engineering refinement to ensure accurate and reliable sensing and processing of the atrial signal. Due to its unique technology, the DX System has continued to drive Biotronik’s U.S. customer adoption since it was initially introduced in February 2013.

•        Biotronik Home Monitoring offers the highest patient compliance [2] and has demonstrated mortality reduction for patients with heart failure.[3]

•        BiotronikProMRI ICD family is equipped with competitive battery capacity to offer longevity leadership even with energy-consuming processes active.[4]

About ProMRI
BIOTRONIK ProMRI technology enables patients with a pacemaker, implantable defibrillator or cardiac monitor to undergo an MRI scan. Internationally, BIOTRONIK has the broadest portfolio of cardiac devices approved for use in the MR environment on the market. 

For more information: www.biotronik.com/promri
 
References:
1. Roguin A, et al. Europace. 2008; 10(3).
2. Varma N, et al. Circ: Arrhythmia Electrophysiology. 2010 Oct;3(5)
3. Hindricks G. et al. The Lancet. 2014, 384(9943).
4. Data on file with Biotronik

Related Content

Results of the STROKE-VT trial showed direct oral anticoagulants (DOACs) are more effective than aspirin in reducing cerebrovascular events, including stroke in patients undergoing ventricular tachycardia ablation.

Results of the STROKE-VT trial showed direct oral anticoagulants (DOACs) are more effective than aspirin in reducing cerebrovascular events, including stroke in patients undergoing ventricular tachycardia ablation.

News | EP Lab | July 29, 2021
July 29, 2021 – Results of the STROKE-VT tr...
The devices compared in the study were the Bardy Carnation Ambulatory Monitor long-term continuous ECG system (left) and the BioGuardian MCT cardiac event monitor (right).  #HRS21 #HRS2021 #HeartRhythm21

The devices compared in the study were the Bardy Carnation Ambulatory Monitor long-term continuous ECG system (left) and the BioGuardian MCT cardiac event monitor (right). 

News | EP Lab | July 29, 2021
July 29, 2021 – Results from a new clinical trial find human-oversight dependent continuous electrocardiography (ECG)
St. Jude Medical Pays $27 Million for Allegedly Selling Defective ICD and CRT-D devices
News | EP Lab | July 28, 2021
July 28, 2021 — The U.S. Justice Department announced earlier this month that St. Jude Medical Inc.
Heart Rhythm Society, HRS, 2021 Late-Breaking Clinical Trials in Electrophysiology. #HRS #HRS2021 #HRS21 #Heartrhythm21
Feature | EP Lab | July 28, 2021
July 28, 2021 — Here is the complete list of late-breaking clinical trials (LBCT) and links to articles on all of the
The AcQMap 3D Imaging and Mapping System, left, and the AliveCor KardiaMobile device and app for personal ECG monitoring using a smartphone, right. The companies plan to use remote monitoring to see if it helps improve care for ablation patients.

The AcQMap 3D Imaging and Mapping System, left, and the AliveCor KardiaMobile device and app for personal ECG monitoring using a smartphone, right. The companies plan to use remote monitoring to see if it helps improve care for ablation patients.

News | EP Lab | July 27, 2021
July 27, 2021 — AliveCor Inc., which offers FDA-cleared, smart-phone enabled personal electrocardiogram (ECG) technol
Medtronic announced new data from the landmark WRAP-IT study published in Heart Rhythm,[1] demonstrating a significantly lower infection risk for patients who develop hematomas after cardiac implantable electronic devices (CIEDs) when the Tyrx Absorbable Antibacterial Envelope is used at implant. The analysis showed an 82% reduction in major CIED infections among patients with the Tyrx Envelope who developed hematomas compared to patients in the control group who developed hematomas.
News | EP Lab | July 27, 2021
July 27, 2021 — Medtronic announced new data from the landmark WRAP-IT study...
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 ...