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FDA Approves ‘Smart’ Defibrillator for Heart Patients

A new heart implant that will allow patients to safely undergo MRI scans has been approved by the US Food and Drug Administration (FDA).


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The Claria MRI Quad Cardiac Resynchronization Therapy Defibrillator SureScan, made by medical equipment giant Medtronic, will also help people with irregular heart rhythms through the use of sophisticated technology.

Medtronic’s defibrillator has built-in software that monitors the effectiveness of a pulse sent to a patient’s heart and automatically adjusts the rate to a safe level.

MRI Scans

What makes this new product stand out is the ability for patients with the implant to undergo MRI scans. Each year, approximately 12-16 per cent of patients with a cardiac device have conditions that require a scan. However, due to restrictions involving their heart devices, less than one per cent of patients actually have the scan. Previously, physicians had feared an MRI, which uses strong magnetic fields, could interfere with a patient’s heart implant.

Recently Approved

The FDA recently gave approval for Medtronic’s new ‘smart’ defibrillator after the company submitted a premarket notification 510k. A 510k allows the FDA to determine whether a medical device to be marketed is at least as safe and effective as a legally marketed device. A premarket notification would have been needed for Medtronic’s new cardiac implant, as it contains modifications from other devices already on the market.

The key to successful marketing of a new heart implant, such as this one, is getting the product advertised as quickly as possible. How long does it take to get a FDA 510k approved? Well, that depends on the way the company deals with its submission. The FDA have set up a third party review, available with help from companies such as fdathirdpartyreview, to improve the efficiency and timeliness of a 510k process. If medical companies choose to use an accredited person for their 510k submission, the FDA must issue a decision, by law, within 30 days of receiving the premarket notification.

Improving Patient Care

Medtronic says their aim is to help people receive the cardiac treatment they require but also have access to other medical technology, such as MRI scans. Now heart patients, who may also suffer from conditions like cancer, Alzheimer’s disease and joint pain, can have access to all their treatment needs.

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