1. Medtech Insight
  2. >>Archive

Medtronic’s MRI-Compatible ICD System Receives FDA Approval

The first implantable cardioverter defibrillator system for use with an MRI scan has been approved by the FDA: the Evera MRI SureScan ICD System from Medtronic. The company hopes the system, which will allow clinicians to conduct important imaging studies of all anatomical locations, will give Medtronic a competitive edge over other ICDs, and will lead to market share gains in the US.

Medtronic PLC received PMA in September for the first implantable cardioverter defibrillator (ICD) system for use with an MRI scan. The patient population that will benefit from the Evera MRI SureScan ICD System is already indicated for an ICD: those at risk for sudden cardiac arrest (SCA) or ventricular arrhythmias. “ICDs have been saving lives for more than 30 years by delivering a lifesaving shock or painless pacing to stop life-threatening fast or irregular heartbeats,” says Marshall Stanton, MD, vice president and general manager of the tachycardia business at Medtronic. “However, prior to this approval, FDA had contraindicated ICD patients from receiving MRI scans because of potential interactions between the MRI magnet and implanted device.” Further, the Centers for Medicare and Medicare Services (CMS) “does not reimburse MRI scans done on patients who have ICDs or pacemakers that are not labeled for use in MRI scanners,” Stanton notes.

The added benefit of the Evera MRI ICD over non-MRI ICDs is that patients can safely undergo an MRI scan...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Archive

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Ryan Nelson

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Ryan Nelson

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, content format or the method in which you receive and access Medtech Insight, or if you love it how it is, now is the time to have your voice heard.

Patients With Movement Disorders Will Benefit From Medtronic’s Expanded MRI Labeling For DBS

 
• By Marion Webb

Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.

Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic

 
• By Natasha Barrow

In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.

More from Medtech Insight

Alternative Funding Sources Emerge Amid Biotech Industry Challenges

 
• By Jo Shorthouse

The biotech funding landscape is undergoing a fundamental shift. With traditional VC becoming increasingly cautious and selective, industry executives are exploring new avenues for capital. Conversely, this evolution may ultimately benefit the sector's long-term sustainability.

NHS Orders Halt On Unapproved AI Scribes, Vendors Rush To Self-Certify

 
• By Natasha Barrow

NHS England's national chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.

EU/US Trade Deal Raises Questions For Medtech

 
• By Amanda Maxwell

There is still no clarity on how life sciences will be treated in the final agreement.