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:
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

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