CE Mark and First Implant of Sorin’s KORA 100 MRI-Compatible Pacing System

It feels like we’re never far from a Sorin Group press release at the moment, the company having issued two pieces about its stents in the last week. Now the Italian Cardiovascular company has confirmed that it has gained CE Mark approval and seen a first implant of the KORA 100 pacing system, which is MRI compatible.

Background

We’ve covered the issue of MRI compatibility before, it being an issue because pacemaker patients, typically over 65 years are prone to other medical conditions such as arthritis, cancer or stroke that may require MRI examinations for optimal diagnosis and management.

Sorin says its KORA 100 SR and DR pacemakers when implanted with the Sorin BEFLEX pacing lead enable implanted patients to undergo magnetic resonance imaging safely.

Rather cleverly the KORA 100 pacing system automatically detects scanner’s magnetic field switching to a mode that allows safe operation during an MRI examination. Similarly the device senses when the patient leaves the MRI field, and returns to normal operation within five minutes. This Automatic MRI Mode feature, which is patented and available exclusively on Sorin Group pacemakers, limits the amount of time that KORA 100 pacemakers operate in MRI mode.

The KORA 100 pacing system also features technologies, proprietary to Sorin, designed to help physicians manage common cardiovascular co-morbidities such as sleep apnea, atrial fibrillation and heart failure.

Physician comments

Dr. Christian Wollmann, cardiologist at Landesklinikum St. Pölten, Austria, implanted the first KORA 100 in a 79-year old man. Dr. Harald Mayr, head of the Cardiology department at St. Pölten, commented: “The KORA 100 pacing system with the Automatic MRI Mode provides benefits to our patients, the cardiology practice, and to my colleagues in radiology. Because the pacemaker only operates in MRI mode during the actual MRI procedure, I can be more flexible in scheduling my pre-MRI visits. Since the pacemaker automatically switches back to the pre-programmed settings without further intervention, the radiologists can be confident about patient safety after the imaging procedure.”

Company comments

“The KORA 100 with Sorin’s proprietary SafeR algorithm, Sleep Apnea monitoring, and the patented Automatic MRI mode is the clear gold standard in pacing technology today. We are very proud to launch this latest innovative technology from Sorin Group, said Stefano Di Lullo, Sorin Group, President CRM Business Unit.

Source: Sorin, SpA

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