Hospital Outpatient Reimbursement  |  Physician’s Office Reimbursement  |  Prescribing Information

How will your efficiency be enhanced with the fastest growing UEA* in the USA?1

Echocardiography image is courtesy of Dr. Linda Gillam, Atlantic Health System, Morristown, NJ. Individual results may vary.

*Ultrasound Enhancing Agent

Ease of use.

Having access to LUMASON, which does not require special equipment, has allowed us to continue to utilize contrast when needed without additional equipment or staff that would otherwise bring an activated vial into an isolation room.

Critical Care Nurse

The individuals who appear are for illustrative purposes. All persons depicted are models and not real patients or healthcare professionals.

Manually reconstituted in seconds.​

Quick-Activation
With a rapid reconstitution time of 20 Seconds
the prep time for LUMASON® is only 5.5 hours per 1,000 cases.3,4

Ease of use.

Having the convenience of everything I need in a single kit to administer quickly means I can spend more time focusing on the patient.

Emergency Department Physician

The individuals who appear are for illustrative purposes. All persons depicted are models and not real patients or healthcare professionals.

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Ease of Use.

I never realized how much time I spent getting the refrigerated agent from storage, finding the mixer and reconstituting – I guess we never knew we had other options?

Assistant Manager Cardiology

Joint Commission Standards demonstrate that

50% of hospitals continue to fail medication management standards.5

The LUMASON Kit simplifies administration and easily travels with you to the ICU, ER, or anywhere.

PORTABLE KIT
PORTABLE
Icon - No Refrigeration - Green
NO REFRIGERATION
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RAPID ACTIVATION

LUMASON is the only ultrasound enhancing agent with multiple indications and does not require refrigeration.

Image Quality.

Very low MI techniques produce high quality signal-to-noise ratios giving you the ability to be visually decisive.

Lead Sonographer

The individuals who appear are for illustrative purposes. All persons depicted are models and not real patients or healthcare professionals.

Diagnostic quality images with very low MI.6

Case-43-Apical-4CH-Unenhanced.png Case 43 - Apical 4CH Enhanced
Case-43-Apical-2CH-Unenhanced.png Case-43-Apical-2CH-Enhanced.png
Case 43 - Apical 3CH Unenhanced Case-43-Apical-3CH-Enhanced.png

Echocardiography images are courtesy of Dr. Linda Gillam, Atlantic Health System, Morristown, NJ. Individual results may vary.

Does time to Acquisition Matter?

Learning to recognize your segments in 4-chamber, 2-chamber and 3-chamber apical views quickly is the foundation for becoming a Great Sonographer.

3 Seconds

5 Seconds

10 Seconds

Visually Decisive

Echocardiography images are courtesy of Dr. Linda Gillam, Atlantic Health System, Morristown, NJ. Individual results may vary.

Become Visually Decisive.

Echocardiography images are courtesy of Dr. Linda Gillam, Atlantic Health System, Morristown, NJ. Individual results may vary.

Patient Comfort.

Patient’s experiencing back pain doesn’t just increase the time it takes to complete the study, it impacts patient satisfaction.

Cardiac Service Line Manager

The individual who appears is for illustrative purposes. The person depicted is a model and not a real patient.

No Back Pain.

In a 15-month prospective study…

LUMASON® ultrasound enhancing agent was administered 2,137 times with no reports of back pain.7*

* Based on a single-center study of adult patients (age >18 years) receiving a UEA (LUMASON®, Optison™, or Definity®) were prospectively evaluated for clinically significant adverse events defined as either anaphylactoid reactions (rash, flank pain, dyspnea, and wheeze) or true anaphylaxis. Study objectives included the following: determining the major adverse reactions experienced by patients receiving UEA in a clinical setting, assessing whether microbubbles are safe for use in patients with intra-cardiac shunts, and assessing whether the types of adverse reactions differ significantly among the three FDA-approved UEAs.

Safety.

There’s only one agent we trust for our pediatric patients.

Pediatric Nurse

The individuals who appear are for illustrative purposes. All persons depicted are models and not real patients or healthcare professionals.

"CEUS provides exquisite vessel resolution and is a completely non-invasive imaging option that produces comparable information as CT and MR, which have historically been used to diagnose focal liver lesions."

Dr. Stephanie Wilson

LUMASON is the only UEA approved for pediatric patients.3

Safety.

There’s only one agent we trust for our pediatric patients.

Pediatric Nurse

The individual who appears is for illustrative purposes. The person depicted is a model and not a real patient.

The first and only FDA-Approved UEA indicated for characterization of focal liver lesions in pediatric and adult patients.3​​

LUMASON ultrasound enhancing agent can reduce the number of indeterminate diagnoses with conventional ultrasound by >50%.8

Non-Enhanced Ultrasound

LUMASON Arterial Phase

LUMASON Portal Phase

LUMASON Late Phase

Ultrasound image is reprinted with permission from World Journal of Gastroenterology.9 Individual results may vary.

Innovation.

We are looking for a large number of biomedical applications, and are confident that our technology can be used to address a wide range of healthcare challenges, for the best of patient care.

Thierry Bettinger, PhD
Bracco Research Center Geneva Director

The Geneva Center, Bracco Research SA.

Innovation made in Switzerland.

■ Approved in more countries than any other UEA.10

Design features of microspheres may significantly enhance signal and image quality.

LUMASON microspheres are designed to maintain consistent acoustic properties over the entire range of frequencies used in clinical settings.11

1.5 – 2.5 μm
Mean diameter range

≥ 99%
Percent of microspheres ≤ 10μm

100.0% ≤ 20μm
Upper size limit

Shell Elasticity

Soft mono-layer shell and responds at a low MI.12

Core

The microsphere core is made of sulfur hexafluoride gas, designed to be stable and resist pressure changes.12

Safety Update.

LUMASON® Ultrasound Enhancing Agent PI has been updated to bring awareness to all ingredients including, but not limited to, Polyethylene Glycol (PEG). There is a chance to predict the patients who may have possible PEG allergy and if so to prevent them from having hypersensitivity reaction. The measure requested by FDA is not to warn about an additional risk deriving from exposure to LUMASON; instead, FDA has identified a risk minimization measure that could further improve the safety profile of the agents with PEG. In response, the recent ASE Expert Consensus Statement on Hypersensitivity Reactions to Ultrasound Enhancing Agents in Patients with Allergy to PEG states that Lipid-based UEAs, including LUMASON “are contraindicated in patients who have a history of prior hypersensitivity to these UEAs, to Polyethylene Glycol (PEG) macrogol, or to PEG-containing products such as certain bowel preps for colonoscopy or laxatives. The known incidence of these reactions remains low and unchanged (1 in 10,000 administrations). Because the risk-to-benefit ratio for UEAs remains extremely low, the American Society of Echocardiography does not recommend any changes to laboratory policy regarding indications for their use.” If users pay attention to this new identified risk management measure and look for history of possible PEG allergy, we expect to see a further reduction in the rate of hypersensitivity reactions already showing a trend of reduction over the years. Always have cardiopulmonary resuscitation personnel and equipment readily available prior to UEA administration and monitor all patients for hypersensitivity reactions.
The individual who appears is for illustrative purposes. The person depicted is a model and not a real healthcare professional.

Support.

This program was great and I don’t think that there is anything like this anywhere else. Very good classes and not the standard canned presentations that we are accustomed to seeing.  I would encourage all sonographers to participate in this program if given the opportunity to. This is coming from a sonographer that has 20 years of experience and injected over 5000 doses of ultrasound enhancing agents.  The physics, chemistry and explanation of ultrasound enhancing agents were second to none. The interactive nature of the class was great and probably the most important part of the program. You don’t usually get to be this close to people that are the gurus of any specialty. The actual lab portion was invaluable and is the highlight of the course. 
Stephen Ishihara

The individuals who appear are for illustrative purposes. All persons depicted are models and not real healthcare professionals.

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LUMASON® (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use

Indications
LUMASON® (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use is an ultrasound contrast agent indicated for use:

  • in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult and pediatric patients with suboptimal echocardiograms
  • in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients
  • in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patients


IMPORTANT SAFETY INFORMATION
WARNING: SERIOUS CARDIOPULMONARY REACTIONS
Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres. Most serious reactions occur within 30 minutes of administration.

  • Assess all patients for the presence of any condition that precludes administration
  • Always have resuscitation equipment and trained personnel readily available


Contraindications
LUMASON (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use is contraindicated in patients with known or suspected hypersensitivity to sulfur hexafluoride lipid microsphere or its components, such as polyethylene glycol (PEG).

Warnings
Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or shortly following administration of ultrasound contrast agents, including LUMASON. Always have cardiopulmonary resuscitation personnel and equipment readily available prior to LUMASON administration and monitor all patients for acute reactions.

Post-marketing hypersensitivity reactions, including serious hypersensitivity reactions, have been observed during use or shortly following LUMASON administration. These reactions may occur in patients with no history of prior exposure to sulfur hexafluoride lipid-containing microspheres. LUMASON contains PEG. There may be increased risk of serious reactions including death in patients with prior hypersensitivity reaction(s) to PEG.

Systemic embolization may occur in patients with cardiac shunts. Assess patients with cardiac shunts for embolic phenomena following LUMASON administration.

There is a risk of ventricular arrhythmia related to high mechanical index in patients administered LUMASON. LUMASON is not recommended for use at mechanical indices greater than 0.8.

The most common adverse reactions (incidence ≥ 0.5%) are headache (1%) and nausea (0.5%).

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please click here for full Prescribing Information for LUMASON ultrasound contrast agent, including BOXED WARNING on Serious Cardiopulmonary Reactions.

LUMASON is manufactured for Bracco Diagnostics Inc., Monroe Township, NJ 08831 by Bracco Suisse S.A., Plan-les-Ouates Geneve, Switzerland (LUMASON lyophilized powder vial-25 mg lipid-type A/60.7 sulfur hexafluoride gas); Vetter Pharma-Fertigung GmbH & Co. KG, 88212 Ravensburg, Germany (Sodium Chloride 0.9% Injection, USP); B. Braun Melsungen AG, 34212 Melsungen, Germany (Mini-Spike).

LUMASON is a registered trademark of Bracco Diagnostics Inc.

Bracco Diagnostics Inc.
259 Prospect Plains Road, Building H
Monroe Township, NJ 08831 USA
Phone: 609-514-2200
Toll Free: 1-877-272-2269 (U.S. only)
Fax: 609-514-2446

© 2022 Bracco Diagnostics Inc. All Rights Reserved. US-LUM-2000052 06/21

IMPORTANT SAFETY INFORMATION  |  INDICATIONS AND USAGE

LUMASON® (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use

IMPORTANT SAFETY INFORMATION
WARNING: SERIOUS CARDIOPULMONARY REACTIONS
Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres. Most serious reactions occur within 30 minutes of administration.

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