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

 

 

Ultrasound Homepage

Expert makes the case for patient access to radiology reports Patients want a more active role in their care

Sectra announces MR and ultrasound monitoring capabilities for DoseTrack Will no longer be limited to information from ionizing sources

ContextVision unveils VolarView and GOPView XR2Plus Orthopedic package at RSNA Adds enhancements to handheld ultrasounds and orthopedics

Hologic announces partnership with Clarius Mobile Health at RSNA Will integrate its algorithms with handheld ultrasound scanners

Hitachi unveils single broad-based ultrasound probe at RSNA 'Unlike any other in the sector'

DiA Imaging Analysis to develop technology for GE ultrasound Providing accurate and reproducible image interpretation in point-of-care settings

German Armed Forces purchases 142 Philips Lumify app-based ultrasound systems Will be standard equipment in emergency and rescue operations

Focused Ultrasound Foundation receives $10 million donation from anonymous donor 'Huge, transformative' for the field of focused ultrasound

$10 Nintendo chip turns ultrasound machine into 3-D scanner A potential game-changer for obtaining quick scans in the trauma unit

Study finds focused ultrasound can reduce Parkinson's tremor Research underway to find additional applications

GE ultrasound contrast agent Optison gets FDA OK for label change

by Thomas Dworetzky , Contributing Reporter
The FDA has approved a label change that allows GE Healthcare's Optison ultrasound contrast agent to be used in a larger range of cases. Specifically, it downgrades its use in patients with cardiac shunts and for administration by intra-arterial injection from a contraindication to a warning and precaution.

Prior to this labeling shift, to use the agent, perflutren protein-Type A microspheres injectable suspension, in suspected cardiac shunt populations, an agitated saline procedure was needed first.

Story Continues Below Advertisement

qualiTEE - reliabiliTEE - repairabiliTEE - we guaranTEE

Bayer HealthCare Multi Vendor Service will repair your transducer with the same precision and care you provide to your patients. Now offering TotalREPAIR on 140 transducer models! Call us at 1-844-5100 or visit www.mvs.bayer.com to set up an order today.



The change makes Optison the first contrast agent for use in the U.S. to be so labelled, GE said in a statement.

The change has brought positive responses from a number of health care professionals, including Dr. Sharon L. Mulvagh, who is professor of medicine, director of the Women's Heart Clinic and preventive cardiology consultant in cardiovascular diseases at the Mayo Clinic and Mayo Clinic College of Medicine, GE noted.

“This label change will allow more patients access to a diagnostic imaging tool that has established safety and efficacy. The FDA’s decision to remove this contraindication is supported by a body of data from studies demonstrating safety and clinical benefits of all ultrasound contrast agents in patients with cardiovascular diseases,” said Mulvagh.

Mulvagh called the label change “an important step forward in eliminating barriers to ultrasound contrast use and delivering quality diagnostic care of value to our patients.”

Cardiac shunts are quite common and pose a challenge to clinicians. “Up to one-third of our patients have known or suspected cardiac shunts and, thanks to this important FDA decision, they, too, will now have access to ultrasound contrast agents, which offer an inexpensive and radiation-free option for diagnostic imaging,” noted Dr. Steven Feinstein, co-president of the International Contrast Ultrasound Society.

The decision came about thanks to “the overwhelming weight of evidence from clinical trials," noted Dr. Jonathan Lindner, M. Lowell Edwards Professor of Cardiology at the Knight Cardiovascular Center, Oregon Health & Science University.

He added that “most practitioners in the field of echocardiography already realize the benefits of using contrast agents and understand their capacity to improve diagnostic accuracy, improve outcomes, and streamline care. However, a major obstacle to widespread use has been lack of consensus and confusion regarding how far one needs to go to exclude shunts, no matter how small.”

The clinical advantage of appropriate use of the contrast agent was highlighted by the Head of Global Medical Services at GE Healthcare, Mark Hibberd, who added that Optison use will expand the imaging options and facilitate the care of “the clinically important group of patients who have suboptimal echocardiograms, and a need for left ventricular opacification and delineation of LV borders.”

The contrast market is set to surpass $6 billion by 2022, according to GlobalData research announced in April. The market was “just over $4.3 billion in 2015,” giving a compound annual growth rate of 4.9 percent.

Ultrasound 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 ©2001-2017 DOTmed.com, Inc.
ALL RIGHTS RESERVED