DOTmed Home MRI Oncology Ultrasound Molecular Imaging X-Ray Cardiology Health IT Business Affairs
News Home Parts & Service Operating Room CT Women's Health Proton Therapy Endoscopy HTMs Mobile Imaging
SEARCH
Current Location:
>
> This Story


Log in or Register to rate this News Story
Forward Printable StoryPrint Comment

 

 

Cardiology Homepage

New algorithm predicts impact of heart transplants on survival in heart failure patients Acquires information based on 53 data points to predict rate and length of survival

Timothy J. Arens Surmodics announces leadership change and appointment of interim CFO

Early discharge associated with better outcomes after TAVR Researchers find that discharging patients within 72 hours yields clinical benefits

New tool predicts readmission among TAVR patients Recorded a score of 212 associated with a readmission rate of more than 30 percent

Penn Medicine performs first cardiac ablation procedure with the AcQMap system in US Patient is recovering nicely

How 3D printing could reduce complications after TAVR Using the pre-procedure CT data to create a model that can be implanted with a valve

Chicago mobile stroke unit expands to partnering EMS areas Equipped with a 16-slice Siemens' CT scanner

Opportunities and challenges with 3D printing in cardiology A world of potential but costs remain a barrier

Philip Costello Chief of the Radiology Integrated Center for Comprehensive Excellence at the Medical University of South Carolina named 2018-2019 ARRS President

New cardiac MR imaging technique eliminates breath holds and shortens exam time May have applications for imaging cancer patients too

Quadra Assura MP Cardiac
Resynchronization Therapy Defibrillator

FDA gives nod to MR-conditional labeling for Abbott ICD and CRT-D

by John R. Fischer , Staff Reporter
Abbott’s Quadra Assura MP Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Fortify Assura Implantable Cardioverter Defibrillator (ICD) will now come with MR-conditional labeling following FDA approval.

The nod from the FDA toward labeling enables patients in need of an ICD or a CRT-D to acquire one with less worry and anxiety in undergoing MR imaging procedures, and greater specification to ensure safety during such exams in the future.

Story Continues Below Advertisement

The (#1 Resource) for Medical Imaging and Peripherals. Call 1-949-273-8000

As a Master Distributor for major brands Barco, Philips, and Sony, we offer custom imaging solutions. With our renowned OEM Solutions and Service/Repair Center, Ampronix is a one-stop shop for HD Medical LCD Displays--Printers--Recorders--4K Cameras



“It is important that all devices are safe and continue to function as intended in the various environments patients are exposed to,” Avi Fischer, divisional vice president of medical affairs and medical director of Abbott's cardiac rhythm management business, told HCB News. “We have made great advancements in imaging and device-based technologies and therefore, we need to ensure that patients who are receiving these treatments are safe. We also need to make sure that we are designing medical devices with true risk in mind. We need efforts to affirm what we see in the literature.”

The approvals are just two of many for Abbott, which has also received the same consent for its Assurity MRI pacemaker, Ellipse ICD and associated MRI-compatible leads. It also received CE approval in December 2016 for full body MR-conditional labeling for its Proclaim Elite Spinal Cord Stimulation.

In addition to labeling, Abbott’s Fortify Assura ICD and Quadra Assura MP CRT-D are equipped with other innovations to ensure safety, including its TailoredTherapy features, which protect against the application of unnecessary therapy and continuously monitor the condition of a lead to ensure proper delivery of appropriate therapy. The CRT-D also utilizes Abbott’s SynvAV software which adjusts therapy based on real-time changes it detects in a patient’s cardiac condition.

Fischer says that while MR-conditional labeling can be useful in relieving fear and anxiety, it is greatly believed that all cardiac implantable electronic devices (CIEDs), with or without labels, are safe for MR scanning.

“The evidence continues to support the fact that all CIEDs are safe in the MR environment when scanned using the proper protocols,” he said. “It is widely appreciated by the clinical community that this is the case even for those devices without specific MR labeling.”

Cardiology Homepage


You Must Be Logged In To Post A Comment

Advertise
Increase Your
Brand Awareness
Auctions + Private Sales
Get The
Best Price
Buy Equipment/Parts
Find The
Lowest Price
Daily News
Read The
Latest News
Directory
Browse All
DOTmed Users
Ethics on DOTmed
View Our
Ethics Program
Gold Parts Vendor Program
Receive PH
Requests
Gold Service Dealer Program
Receive RFP/PS
Requests
Healthcare Providers
See all
HCP Tools
Jobs/Training
Find/Fill
A Job
Parts Hunter +EasyPay
Get Parts
Quotes
Recently Certified
View Recently
Certified Users
Recently Rated
View Recently
Certified Users
Rental Central
Rent Equipment
For Less
Sell Equipment/Parts
Get The
Most Money
Service Technicians Forum
Find Help
And Advice
Simple RFP
Get Equipment
Quotes
Virtual Trade Show
Find Service
For Equipment
Access and use of this site is subject to the terms and conditions of our LEGAL NOTICE & PRIVACY NOTICE
Property of and Proprietary to DOTmed.com, Inc. Copyright ©2001-2018 DOTmed.com, Inc.
ALL RIGHTS RESERVED