Medtronic cardiac devices secure FDA approval to enable patient access to diagnostic imaging

16 October 2016 (Last Updated October 16th, 2016 18:30)

Medtronic has secured US Food and Drug Administration (FDA) approval for its suite of cardiac rhythm and heart failure devices and leads to be scanned in both 3 and 1.5 Tesla (T) magnetic resonance imaging (MRI) machines.

Medtronic has secured US Food and Drug Administration (FDA) approval for its suite of cardiac rhythm and heart failure devices and leads to be scanned in both 3 and 1.5 Tesla (T) magnetic resonance imaging (MRI) machines.

This advancement gives patients with Medtronic SureScan MR-conditional pacemakers, implantable cardioverter-defibrillators (ICDs), cardiac resynchronisation therapy-defibrillators (CRT-Ds) and leads access to MRI scans on any part of the body.

Every year, around 12-16% of patients with cardiac devices have a condition in which MRI would normally be prescribed, but less than 1% receive a scan due to device or lead restrictions.

"Advancements in MR-conditional cardiac device technology give patients more access to this important diagnostic tool."

Prior to the availability of MR-conditional technology, patients with cardiac devices were contraindicated from undergoing MRI scans to avoid a potential interaction between the MRI and the device function.

North Carolina-based WakeMed Heart and Vascular Physicians cardiologist Marc Silver said: "The potential interaction between cardiac devices and MRIs has been a long-running concern for patients and physicians.

"Fortunately, advancements in MR-conditional cardiac device technology give patients more access to this important diagnostic tool."

MRI is an imaging technology used to diagnose conditions such as stroke, cancer, Alzheimer's disease, and muscle, bone and joint pain.

3T MRI provides better image quality, better diagnosis and reduced scan duration compared to 1.5T scans.

Over the next five years, the adoption of 3T MR systems is expected to reach approximately 30-40% of hospitals across the US.

Medtronic cardiac rhythm and heart failure division vice president and general manager of the heart failure business, and medical director David Steinhaus said: "Our goal is to help patients get the cardiac device therapy they need while ensuring they also retain access to other needed tools, such as diagnostic MRI.

"We are proud to be the first and only company to offer a comprehensive suite of MR-conditional devices and leads in the US."