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Biotronik Wins FDA Approval for Iperia; a Family of Cardiac Defibrillators

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The leading German multinational biomedical technology company- Biotronik got its Iperia ProMRI HF-T approved by the US Food and Drug Association (FDA).

germany biotronik official logoThe Iperia is a family of Implantable Cardiovascular Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT Ds) which are designed to detect and treat vascular tachyarrhythmias and provide rate adaptive bradycardia pacing support.

iperia 7 vr-t biotrinik

Figure 1. Iperia 7 HF-T (Image courtesy: Biotronik)

According to Biotronik, the HF-T version of Iperia provides Cardiac Resynchronization Therapy (CRT) through biventricular pacing. These are designed to collect diagnostic data in order to aid the physician’s assessment of a patient’s condition. This also helps the physician to assess the performance of the implanted device.

The FDA approval of Iperia HF-T demonstrates the shift that is happening in cardiovascular patient care,” said Marlou Janssen, President, BIOTRONIK, Inc.BIOTRONIK now offers a comprehensive portfolio of MR conditional ICDs. We’re driving the standard of care to new levels by providing physicians and hospitals with innovative, reliable, cardiac devices that ensure patients have access to imaging technology critical to diagnosing and treating future illness and injury. This is technology that is making a difference in patient’s lives.”

ProMRI Devices Biotronik

Figure 2. Biotronik ProMRI Devices (Image courtesy: Biotronik)

The Iperia HF-T has been developed using the ProMRI technology that enables patients with a pacemaker, implantable defibrillator, cardiac monitor or CRT D to undergo an MRI scan. The Iperia CRT Ds are indicated for use in patients with the following conditions:

  • Indicated for ICD therapy
  • Receiving optimized and stable congestive heart failure drug therapy
  • Symptomatic CHF
  • Intraventricular conduction delay

At the same time the Iperia devices are contraindicated for use in patients with the following conditions:

Patients whose ventricular tachyarrhythmia may have transient or reversible causes such as:-

  1. Acute myocardial infarction
  2. Digitation intoxication
  3. Drowning
  4. Electrocution
  5. Hypoxia
  6. Sepsis

Testing carried out by Biotronik has indicated that there may be an interaction between the implanted CRT D systems and cellular phones due to either the cellular phone signals or the magnet within the telephone. This may lead to the inhibition of the therapy when the cellular phone is within 6 inches of the CRT D.

One unique feature of the Iperia devices is the home monitoring system that is designed to notify clinicians in less than 24 hours of changes to the patient’s condition or status of the implanted device.

Biotronik has been delivering cardiac solutions since its setup. After its invention of the first German pacemaker Biotronik continues to serve patients with cardiac disorders and Iperia HF T is one such serving.

Featured image credit: Defibrillator Practice On A CPR © praisaeng (Stock Photo ID: 86177600)

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