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Medtronic has receive U.S. 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) and cardiac resynchronization therapy-defibrillators (CRT-Ds) and leads access to MRI scans on any part of the body.
Each year, approximately 12%-16% of patients with cardiac devices have a condition in which MRI would normally be prescribed, but less than 1% receives a scan because of device or lead restrictions. Before 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.
“The potential interaction between cardiac devices and MRIs has been a long-running concern for patients and physicians,” said Marc Silver, M.D., cardiologist at WakeMed Heart and Vascular Physicians in Raleigh, N.C. “Fortunately, advancements in MR-conditional cardiac device technology give patients more access to this important diagnostic tool.”
MRI is an important imaging technology to diagnose conditions such as stroke, cancer, Alzheimer’s disease, and muscle, bone and joint pain. 3T MRI offers better image quality, better diagnosis and reduced scan duration compared to 1.5T scans. In the next five years, the adoption of 3T MR systems is expected to reach approximately 30%-40% of hospitals across the United States.
“While 1.5T scanners still comprise the majority of installations, 3T scanners are expected to comprise more than half of new units – with some centers having only 3T scanners – since they offer faster scans and higher resolution images,” said Yair Safriel, M.D., neuroradiologist and chief medical officer at Pharmascan Clinical Trials and University of South Florida. “Approval for MRI conditional scanning at both 1.5 and 3T allows patients to have improved access to MRI at a time and place most appropriate for their care. And with 3T scanning, physicians and radiologists gain a clearer look into soft tissues, particularly critical when diagnosing serious conditions, often involving the brain and spine.”
Patients in the U.S. with the following devices are now eligible for 1.5 and 3T MRI scans:
- Advisa MRI(TM) Pacemakers and Micra(TM) Transcatheter Pacemaker
- Amplia MRI(TM) and Compia MRI(TM) Cardiac Resynchronization Therapy Defibrillators
- Evera MRI(TM) and Visia AF(TM) MRI DF-1 and DF4 Implantable Cardioverter Defibrillators
- Reveal LINQ(TM) Insertable Cardiac Monitor
- SureScan® Pacing, Defibrillation and Left-Heart Leads
Additionally, Medtronic now offers more options for ICD patients undergoing device replacement surgery, enabling MRI access to an even broader base of patients.
“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,” said David Steinhaus, M.D., vice president and general manager of the Heart Failure business, and medical director for the Cardiac Rhythm and Heart Failure division of Medtronic. “We are proud to be the first and only company to offer a comprehensive suite of MR-conditional devices and leads in the U.S.”
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.
For Further Information
More on the U.S. markets for cardiac surgery and heart valve devices can be found in the 2016 edition report published by iData entitled U.S. Markets for Cardiac Surgery and Heart Valve Devices, which covers market segments for the following: tissue heart valves, mechanical heart valves, annuloplasty repair, transcatheter mitral valve repair, transcatheter heart valve implantation, on-pump coronary artery bypass, off-pump coronary artery bypass, endoscopic vessel harvesting, anastomosis assist, cardiac ablation, transmyocardial revascularization, ventricular assist, intra-aortic balloon pumps, artifical hearts, patent foramen ovale, and atrial and ventricular septal devices.
Recent reports on the markets for cardiac surgery and heart valve devices cover the U.S. and 15 countries in Europe. Full reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. Register online or email us at [email protected] for a U.S. Markets for Cardiac Surgery and Heart Valve Devices report brochure and synopsis.
About iData Research
iData Research (www.idataresearch.com) is an international market research and consulting group focused on providing market intelligence for medical device and pharmaceutical companies. iData covers research in: Dental Operatory Equipment, X-Ray Imaging, Vascular Access, Peripheral Vascular, Endoscopy, Interventional Cardiology, Cardiac Surgery, Cardiac Rhythm Management, Electrophysiology, Diagnostic Imaging, Operating Room Equipment, Surgical Microscopes, Robotics and Surgical Navigation, Oncology, Ultrasound, Laparoscopy, Urology, Gynecology, Spinal Implants and VCF, Spinal MIS, Orthopedic Soft Tissue Repair and Regeneration, Orthopedic Trauma, Large and Small Joints, Anesthesiology, Wound Management, Orthopedics, Ophthalmics and more.
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