Free press releases distribution network?

Agency / Source: General Electric Company

Check Ads Availability|e-mail Article


Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!



GE Healthcare Medical Diagnostics Relaunches Optison™ Contrast Agent - GE Healthcare Medical Diagnostics today announced the market reintroduction of Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), a diagnostic ultrasound contrast agent for use in select echocardiograms
GE Healthcare Medical Diagnostics Relaunches Optison™ Contrast Agent

 

PRZOOM - /newswire/ - Princeton, NJ, United States, 2010/07/12 - GE Healthcare Medical Diagnostics today announced the market reintroduction of Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), a diagnostic ultrasound contrast agent for use in select echocardiograms. NYSE: GE

   
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Medical Services/Equipment Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

Optison is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders. The safety and efficacy of Optison with exercise stress or pharmacologic stress testing have not been established.

"We are excited to announce the reintroduction of Optison,” said Kimberly Wolf, Regional Marketing Leader - Americas, GE Healthcare Medical Diagnostics. “The product gives medical professionals an option in ultrasound contrast agents when they need to increase diagnostic accuracy by converting non-diagnostic echo studies to diagnostic images.”

Optison is an FDA-approved ultrasound contrast agent available in a ready-to-use formulation, providing the benefits of fast preparation time, ease of use, portability, and flexible dosing. The recommended dose is 0.5 mL injected into a peripheral vein. This may be repeated for further contrast enhancement as needed, but the maximum total dose should not exceed 8.7 mL in any one patient study.

Optison was approved by the US Food and Drug Administration (FDA) in 1998. In June 2009, GE Healthcare was no longer able to supply Optison to the market due to manufacturing difficulties. Since that time, the company has conducted a thorough review of the manufacturing process and changes have been made to minimize any future disruptions to product supply.

“Optison gives cardiologists, sonography professionals, cardiac catheterization laboratory nurses, echocardiography laboratory staff, and most importantly patients, an additional option in ultrasound contrast agent selection,” said Anthony N. DeMaria MD, Professor of Medicine, Judith and Jack White Chair in Cardiology at the University of California, San Diego School of Medicine.

According to the Intersocietal Commission for the Accreditation of Echocardiography Laboratories (ICAEL), an estimated 10 million echocardiograms are performed in the United States each year. As many as 30% of patients receiving stress echocardiography may receive nondiagnostic or poor-quality images. Echocardiographic contrast agents can improve imaging. Clinical trials demonstrate that suboptimal echocardiograms can be converted to diagnostic examinations in 75% to 90% of patients.

The American Society of Echocardiography (ASE) recommends the use of contrast whenever two or more left ventricular wall segments are not seen on non-contrast images. In clinical studies supporting the marketing application of Optison, there was significantly increased left ventricular heart opacification and improved endocardial border delineation with Optison compared to non-enhanced echocardiograms.

“I am pleased that Optison is back on the market because it offers an important tool for improving the accuracy and reliability of echocardiograms, without unnecessarily exposing patients to ionizing radiation or dye,” said Steven B. Feinstein, MD, FACC, FESC, Professor of Medicine and Director of Echocardiography, Rush University Medical Center, Chicago. “By improving the accuracy of echocardiograms, the use of ultrasound contrast agents also avoids redundant downstream testing."

Optison is supported by more than 1 million administered doses and nearly 12 years of clinical use, with only 16 serious adverse events reported since 1998. Of the reported adverse reactions following the use of Optison the most frequently reported were headache, nausea and/or vomiting, warm sensation or flushing, and dizziness. Some adverse reactions have been identified during the postmarketing use of perflutren-containing microsphere products. Fatal cardiac arrests and other serious but non-fatal adverse reactions were uncommonly reported. Most of these uncommon reactions included cardiopulmonary symptoms and signs such as cardiac or respiratory arrest, hypotension, supraventricular and ventricular arrhythmias, respiratory distress, or decreased oxygenation. Reports also identified neurologic reactions (loss of consciousness or convulsions) as well as anaphylactoid reactions. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

About GE Healthcare
GE Healthcare (gehealthcare.com) provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the world at a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems.

Our "healthymagination" vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing costs, increasing access and improving quality and efficiency around the world. Headquartered in the United Kingdom, GE Healthcare is a $16 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries.

For our latest news, please visit newsroom.gehealthcare.com/.

Important Risk and Safety Information About Optison

Important Boxed Warning and Risk Information About Optison

WARNING: Serious Cardiopulmonary Reactions

Serious cardiopulmonary reactions, including fatalities, have occurred during or following perflutren-containing microsphere administration.

• Assess all patients for the presence of any condition that precludes Optison administration (see CONTRAINDICATIONS).

• In patients with pulmonary hypertension or unstable cardiopulmonary conditions, monitor vital sign measurements, electrocardiography, and cutaneous oxygen saturation during and for at least 30 minutes after Optison administration (see WARNINGS).

• Always have resuscitation equipment and trained personnel readily available.

Please see continued Important Risk and Safety Information in Full Prescribing Information at gehealthcare.com/.

Optison is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders. The safety and efficacy of Optison with exercise stress or pharmacologic stress testing have not been established.

Do not administer Optison to patients with known or suspected:

Right-to-left, bidirectional, or transient right-to-left cardiac shunts,

Hypersensitivity to perflutren, blood, blood products, or albumin (see WARNINGS).

Do not administer Optison by intra-arterial injection.

Safety and efficacy have not been established in pediatric patients, or in patients with congenital heart disease (see WARNINGS).

In postmarketing use, uncommon but serious reactions observed during or shortly following perflutren-containing microsphere administration included fatal cardiac or respiratory arrest, loss of consciousness, convulsions, symptomatic arrhythmias (atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, or fibrillation), hypotension, respiratory distress, or cardiac ischemia (see ADVERSE REACTIONS).

Always have cardiopulmonary resuscitation personnel and equipment readily available prior to Optison administration and monitor all patients for acute reactions.

Postmarketing reports of acute anaphylactoid reactions including shock, bronchospasm, upper airway swelling, loss of consciousness, urticaria, and pruritus, have occurred in patients with no prior exposure to perflutren-containing microsphere products. Monitor all patients for signs and symptoms of anaphylactoid reactions (see ADVERSE REACTIONS).

This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral disease.

A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral disease or CJD have ever been identified for albumin.

The following adverse reactions have been identified during the postmarketing use of perflutren-containing microsphere products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Fatal cardiac arrests and other serious but nonfatal adverse reactions were uncommonly reported. Most of these uncommon reactions included cardiopulmonary symptoms and signs such as cardiac or respiratory arrest, hypotension, supraventricular and ventricular arrhythmias, respiratory distress, or decreased oxygenation. Reports also identified neurologic reactions (loss of consciousness or convulsions) as well as anaphylactoid reactions (see WARNINGS).

 
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Medical Services/Equipment Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

Agency / Source: General Electric Company

 
 

Availability: All Regions (Including Int'l)

 

Traffic Booster: [/] Quick PRZOOM - Press & Newswire Visibility Checker

 

Distribution / Indexing: [+] / [Company listed above is a registered member of our network. Content made possible by PRZOOM / PRTODAY indexing services]

 
 
# # #
 
 
  Your Banner Ad showing on ALL
Medical Services/Equipment articles,
CATCH Visitors via Your Competitors Announcements!


GE Healthcare Medical Diagnostics Relaunches Optison™ Contrast Agent

Company website links NOT available to basic submissions
It is OK to republish and/or LINK any newswire for any legitimate media purpose as long as you name PRZOOM - Press & Newswire and LINK as the source.
 
  For more information, please visit:
Is this your article? Activate ALL web links by Upgrading to Press Release PREMIUM Plan Now!
GE News Center |
Contact: Aleisia Gibson - GE.com 
609-514-6046 aleisia.gibson[.]ge.com
 
PRZOOM / PRTODAY - Newswire Today disclaims any content contained in this article. If you need/wish to contact the company who published the current release, you will need to contact them - NOT us. Issuers of articles are solely responsible for the accuracy of their content. Our complete disclaimer appears here.
IMPORTANT INFORMATION: Issuance, publication or distribution of this press release in certain jurisdictions could be subject to restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with the applicable rules and regulations in the particular jurisdiction. This press release does not constitute an offer or an offering to acquire or subscribe for any General Electric Company securities in any jurisdiction including any other companies listed or named in this release.

Medical Services/Equipment via RSSAdd NewswireToday - PRZOOM Headline News to FeedBurner
Find who RetweetFollow @NewswireTODAY



Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!




Read Latest Press Releases From General Electric Company / Company Profile


Read Medical Services/Equipment Most Recent Related Press Releases:

Sparta Systems Broadens Partnership with TrackWise Implementation Specialist Equality Systems
Thales Launches the Pixium Portable 3543 DR Wifi Enabled Flat Panel Detector
GE Healthcare Showcases Industry-first Technologies and Digital Solutions, Focused on Improving Outcomes, At RSNA 2016
Agfa and LCsys Team Up to Launch ABSOLUT-ID, Their Turnkey Integrated Solution for the Production of High Security ID Cards
ZOLL Technology for Improving CPR Quality to be Showcased at American Heart Association Annual Conference
AccuVein to Exhibit Leading Vein Visualization Technology at American Society for Dermatologic Surgery Annual Meeting
US Biomedical Textiles Transform Implant Device Technology by Aligning to Changes in Patient Preference Finds Frost & Sullivan
Frost & Sullivan Commends Influence Health for Constantly Evolving its Patient Engagement Products to Accelerate Market Transformation
Frost & Sullivan Awards Carestream Top Honors for OnSight 3D Extremity System
Sparta Systems Launches the Next-Generation Cloud Solution Stratas QMS

Boost Your Social Network
& Crowdfunding Campaigns


LIFETIME SOCIAL MEDIA WALL
 
NewswireToday Celebrates 10 Years in Business
Find business coaching, life coaching, executive coaching and corporate coaching, best selling coaching books, ...



PREMIUM Members


Visit  La Bella Bakery Artisan Bakery Arizona

Visit  JobsWare.com

Visit  Triggr & Bloom







 
  ©2016 PRZOOM — Limelon Advertising, Co.
Home | About PRZOOM | Advertise/Pricing | Contact | Investors | Privacy/TOS | Sitemap | FRANCAIS
newswire, PR free press releases distribution service magazines engine news alert newsroom press room breaking news public relations articles company news alerts newswiredistribution ezine bizentrepreneur biznewstoday digital business report market search pr firms agencies reports distri-bution today investor relation successful internet entrepreneur newswire distribution prtoday.com freenewswiredistribution asianewstoday bizwiretoday USA pr UK today