Tell us more about Evera MRI SureScan.
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Dr Mauro Biffi
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Evera MRI SureScan implantable cardioverter-defibrillator (ICD) system is the first ICD system approved for magnetic resonance imaging (MRI) scans positioned on any region of the body. It features a contoured shape with thin, smooth edges that better fits inside the body, increasing patient comfort by reducing skin pressure by 30 per cent. In addition, Evera MRI is paired with the Sprint Quattro Secure family of ICD leads, which has 10 years of proven performance with active monitoring and is safe for use in an MRI environment. Evera MRI includes SmartShock 2.0 – an exclusive shock reduction algorithm that enables the device to better differentiate between dangerous and harmless heart rhythms and deliver shock only in response to a genuine arrhythmia event. SmartShock technology delivers a 98-per cent inappropriate shock free rate at one year. Also included in the Evera MRI is OptiVol 2.0 Fluid Status Monitoring and complete diagnostics, which helps to identify patients at risk of worsening heart failure and atrial fibrillation.
What are its major advantages?
Evera MRI SureScan comes with several advantages. There are no regional restrictions and a person with an implanted Evera ICD can get an MRI scan done for any part of the body. It is estimated that 50 – 75 per cent of patients with an implantable cardiac device will need an MRI scan over the lifetime of their device. And the launch of these devices will be a boon for all such patients.
Secondly, its SmartShock 2.0 technology which is an exclusive shock reduction algorithm that enables the device to better differentiate between dangerous and harmless heart rhythms and deliver shock only in response to a genuine arrhythmia event. While the majority of shocks delivered are necessary to treat potentially fatal arrhythmias, studies estimate that approximately 20 per cent of patients with implantable defibrillators may experience inappropriate shocks in response to a benign arrhythmia or electrical noise sensed by the device. SmartShock technology helps to eliminate these inappropriate shocks, and delivers a 98-per cent inappropriate shock free rate at one year.
What are the characteristics that make it safe for MRI?
The Surescan technology used in these devices makes it safe for MRI scans. This trademarked technology from Medtronic has advanced circuit designs, software as well as device programming making it safer for MRI. Apart from this, the material of the device has also been modified in order to reduce the amount of ferro-magnetic substances, thereby reducing the interference with the powerful magnetic fields and radio waves which are a part of MRI scans.
How will this technology help imaging evolve?
It is estimated that as many as 63 per cent of ICD patients will need an MRI within 10 years of receiving a device. Until the availability of MR-conditional ICD systems, patients with devices have been contraindicated from receiving MRI scans because of potential interactions between the MRI and device function. With this technology, imaging will be accessible to more and more people who need to undergo this very critical test of diagnosis.
Tell us about how the product has been adopted by healthcare industry?
Medtronic was the first to launch the MRI conditional pacemaker in 2008. In the past few years, it has been witnessed that the adoption of this device has increased rapidly. Today, more than 25 per cent of the Medtronic dual chamber pacemakers implanted in India is MRI conditional. And a similar response is expected for the new products as well.
How cost-effective is it? How do you plan to market it in India?
The new products are priced at a nominal 10 per cent premium over the existing models – in order to make it more affordable and accessible to everybody.
As mentioned earlier, there are as many as 63 per cent of ICD patients who will need an MRI scan within the next 10 years. The product would be marketed to these set of patients and answer their unmet need of not being able to undergo this critical test of diagnosis for accurate analysis of disease condition.