Engineered for
consistency

Optison can enhance your suboptimal studies with microspheres consistent in concentration, composition, and size range.

Microspheres Efficacy Safety Convenience Guidelines Supply Case Studies

The Consistency of the Optison Microsphere

Size

  • Mean diameter size of 3.0–4.5 μm (32.0 μm max)1
  • 95% of microspheres are less than 10 μm1

Concentration

  • Each vial contains up to 2.4 billion microspheres1

Composition

  • Optison microspheres are preformed and do not require activation; simply invert the vial and gently rotate to resuspend microspheres
  • Preformed microspheres enable contrast portability
Next

Optison Microspheres Convert Non-diagnostic Studies to Diagnostic Images1,2

Contrast-enhanced
Non-enhanced
Contrast-enhanced
Contrast-enhanced
Next Previous

Optison Microspheres Demonstrated Improved Visualization

In NDA clinical studies, Optison significantly increased the length of endocardial border that could be visualized both at end-systole and end-diastole in suboptimal echocardiograms1

Left ventricular endocardial border length before Optison 0.5 mL IV*

Left ventricular endocardial border length before and after Optison 0.5 mL IV*†

Study A (n=101)

  • (n=87)
  • 7.7 cm ± 3.0 cm
  • No Contrast
  • 0 mL (Baseline)
  • Optison 0.5 mL IV 12.0 ± 4.9
  • Contrast-Enhanced
  • 56% increase

Study B (n=102)

  • (n=87)
  • 8.1 cm ± 3.4 cm
  • No Contrast
  • 0 mL (Baseline)
  • Optison 0.5 mL IV 12.4 ± 4.9
  • Contrast-Enhanced
  • 53% increase

Length at End-Systole

  • 0
  • 5
  • 10
  • 15
  • 20

Study A (n=101)

  • (n=86)
  • 9.3 cm ± 3.4 cm
  • No Contrast
  • 0 mL (Baseline)
  • Optison 0.5 mL IV 15.8 ± 5.1
  • Contrast-Enhanced
  • 70% increase

Study B (n=102)

  • (n=89)
  • 9.6 cm ± 3.7 cm
  • No Contrast
  • 0 mL (Baseline)
  • Optison 0.5 mL IV 16.4 ± 4.6
  • Contrast-Enhanced
  • 71% increase

Length at End-Diastole

  • 0
  • 5
  • 10
  • 15
  • 20

*The differences in the number of enrolled patients and evaluated patients at each dose reflect exclusions based on withdrawal from the trial, or those with technically inadequate or missing images.

An intent-to-treat analysis, with non-favorable values imputed for missing patients, provided qualitatively similar results.

Previous

Optison Microspheres Demonstrated Improved Visualization

Select the mid-chamber or the apex to see
the intensity of left ventricular opacification
before and after Optison

Previous

Optison Microspheres Demonstrated Improved Visualization

In NDA clinical studies, Optison significantly increased left ventricle heart opacification
in suboptimal echocardiograms1

Intensity of left ventricular opacification before Optison 0.5 mL IV (mid-chamber)*†‡

Intensity of left ventricular opacification after Optison 0.5 mL IV (mid-chamber)*†‡

Intensity at End-Diastole

Study A (n=101)

  • No Contrast
  • 39.5 ± 16.9 (n=91)
  • 0 mL (Baseline)

45% increase

  • Contrast-Enhanced
  • 57.3 ± 26.8 (n=91)
  • 0.5 mL

Study B (n=102)

  • No Contrast
  • 40.4 ± 17.4 (n=95)
  • 0 mL (Baseline)

32% increase

  • Contrast-Enhanced
  • 53.3 ± 20.7 (n=97)
  • 0.5 mL

Intensity at End-Systole

Study A (n=101)

  • No Contrast
  • 40.0 ± 18.1 (n=91)
  • 0 mL (Baseline)

43% increase

  • Contrast-Enhanced
  • 57.4 ± 26.7 (n=90)
  • 0.5 mL

Study B (n=102)

  • No Contrast
  • 40.9 ± 17.5 (n=95)
  • 0 mL (Baseline)

31% increase

  • Contrast-Enhanced
  • 53.6 ± 21.0 (n=96)
  • 0.5 mL
Mid-Chamber

*Intensity measured by videodensitometry in arbitrary gray scale units (0-255).

The differences in the number of enrolled patients and evaluated patients at each dose reflect exclusions based on withdrawal from the trial, or those with technically inadequate or missing images.

An intent-to-treat analysis, with non-favorable values imputed for missing patients, provided qualitatively similar results.

Previous

Optison Microspheres Demonstrated Improved Visualization

In NDA clinical studies, Optison significantly increased left ventricle heart opacification
in suboptimal echocardiograms1

Intensity of left ventricular opacification before Optison 0.5 mL IV (apex)*†

Intensity of left ventricular opacification after Optison 0.5 mL IV (apex)*†

Intensity at End-Diastole

Study A (n=101)

  • No Contrast
  • 46.7 ± 19.7 (n=91)
  • 0 mL (Baseline)

43% increase

  • Contrast-Enhanced
  • 67.0 ± 30.1 (n=91)
  • 0.5 mL

Study B (n=102)

  • No Contrast
  • 43.7 ± 19.9 (n=95)
  • 0 mL (Baseline)

47% increase

  • Contrast-Enhanced
  • 64.4 ± 25.3 (n=97)
  • 0.5 mL

Intensity at End-Systole

Study A (n=101)

  • No Contrast
  • 46.9 ± 20.1 (n=91)
  • 0 mL (Baseline)

37% increase

  • Contrast-Enhanced
  • 64.1 ± 30.2 (n=90)
  • 0.5 mL

Study B (n=102)

  • No Contrast
  • 45.0 ± 19.6 (n=95)
  • 0 mL (Baseline)

37% increase

  • Contrast-Enhanced
  • 61.6 ± 26.7 (n=96)
  • 0.5 mL
Apex

*Intensity measured by videodensitometry in arbitrary gray scale units (0-255).

The differences in the number of enrolled patients and evaluated patients at each dose reflect exclusions based on withdrawal from the trial, or those with technically inadequate or missing images.

An intent-to-treat analysis, with non-favorable values imputed for missing patients, provided qualitatively similar results.

Next

The Established Safety Profile of the Optison Microsphere

Adverse events most frequently reported in NDA clinical trials were mild1

Headache
5.4%
Nausea and/or vomiting
4.3%
Warm sensation or flushing
3.6%
Dizziness
2.5%
Previous

The Optison Microsphere Is Composed of a Natural Human Serum Albumin Shell

The Convenience of Optison Microsphere

Portability: Ready when you are

  • Easy bedside resuspension allows quick access to contrast in the lab or on the go
  • No vial mixer required to resuspend
  • Stable at room temperature for up to 24 hours; if unused, can be returned safely to refrigerator for reuse at a later time—up to five times maximum before expiration date12

Fast Prep: From resuspension to injection in less than 60 seconds1

  • Simply invert vial or gently rock-and-roll between palms to resuspend1
  • Vial may be resuspended repeatedly throughout the day and returned to proper storage if unused; this temperature cycle can occur five times maximum before expiration date12

Flexible Dosing: Simple steps for injection

  • Can be injected at any stage of echocardiogram procedure1
  • Multiple doses may be administered in the same study for further contrast enhancement with no waiting period1
  • Recommended dose is 0.5 mL injected into a peripheral vein, up to 5.0 mL in any 10-minute period; do not exceed 8.7 mL in any patient1

Contrast Indication in Echocardiography

ASE and IAC agree on use of ultrasound contrast in suboptimal echocardiograms

  • The American Society of Echocardiography (ASE) and the 2013 Intersocietal Accreditation Commission (IAC) Standards recommend contrast when there is nonvisualization of at least two of six contiguous segments in the standard apical echocardiographic views2,13

These standards also discuss off-label uses which have not been proven to be safe and effective for ultrasound imaging agents.

Next

GE Healthcare now has an FDA-approved internal manufacturing site for Optison

GE Healthcare has built a multimillion-dollar manufacturing facility in Oslo, Norway, making it the only ultrasound contrast
media manufacturer to supply its own product to the US market.

Manufacturing Optison in Oslo

  • Adding this manufacturing site for Optison increases our capacity to meet market demands and helps to ensure a
    consistent supply to the contrast media market

The Oslo facility offers a combination of advanced technology, sophisticated automation,
experienced staff, and organizational competencies that include quality control, product knowledge,
and clinical understanding.

  • As part of the development of the new Oslo facility, a series of Design of Experiments (DoE studies) were performed to identify
    all critical process parameters and their impact on product features
    • DoE studies have helped to create a reliable process, making certain that the product is manufactured within specifications
      every time
Next Previous

GE Healthcare now has an FDA-approved internal manufacturing site for Optison

Optison is produced through multiple steps that ensure microspheres are properly suspended in the solution

  • Evenly distributed gas/albumin before milling
  • Optison is produced by milling a heated albumin solution in the presence of perflutren
    • All critical mechanisms are controlled during formation of the active ingredient14,15
    • During the manufacturing process for Optison, albumin molecules form a flexible, strong, and tight stabilizing structure at the OFP (octafluoropropane) bubble/water interphase to ensure echogenic and suitably stable microspheres after administration (in vivo)14,15
    • Mechanical mixing equipment results in less variation during manufacturing14
    • All manufacturing equipment is located in the same area to avoid complications that may occur during transportation
Previous

GE Healthcare now has an FDA-approved internal manufacturing site for Optison

The manufacturing site in Oslo has experience in aseptic and small-scale manufacturing

The Oslo manufacturing site, which now has a dedicated Optison facility, has been manufacturing sterile injectable contrast agents for decades and has more than 10 years of formal, controlled pharmaceutical development experience in all imaging modalities, including:

  • Positron-emission tomography (PET) — Vizamyl™ (Flutemetamol F 18 Injection)
  • Single-photon emission tomography (SPECT) — DaTscan™ (Ioflupane I 123 Injection)
  • X-ray/computerized tomography (CT), magnetic resonance imaging (MRI) —
    Omnipaque™ (Iohexol) Injection, Visipaque™ (Iodixanol) Injection, and Omniscan™ (Gadodiamide)
  • Ultrasound — Sonazoid™ (Perflubutane) Injection; investigational agent

Optison, Vizamyl, DaTscan, Omnipaque, Visipaque, Omniscan, and Sonazoid are trademarks of General Electric Company or one of its subsidiaries.

Case Studies

+

Patient Detail

1
female patient

Chest Pain

67

Years Old

130/76

Blood Pressure

5'6"

Height

199

Pounds

Interpretation of Unenhanced and Contrast-Enhanced Echocardiograms

Due to poor endocardial border definition, ultrasound contrast (Optison) was used.

After injection of Optison, the echocardiogram shows:

  • Moderate biatrial enlargement
  • RV is moderately enlarged
  • LV cavity size is severely increased
  • Severe eccentric LV hypertophy
  • LV systolic function is severely decreased
  • Visually estimated LVEF is <20%
  • No significant valvular disease is present
  • The entire apex, mid-anterolateral, and mid-anterior segments are abnormal
  • Diffusely increased trabeculation of the apical and anterolateral LV segments with myocardial crypt formation
    • The ratio of trabeculated to compact myocardium is >2.3, consistent with noncompaction cardiomyopathy
  • Compared with a previous study (11 days prior), there has been no significant interval change, allowing for difference in patient positioning (upright at present) and a different estimate of RA pressure, estimated RVSP is comparable.

Important Risk and Safety Information About Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

WARNING — SERIOUS CARDIOPULMONARY REACTIONS:

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration. Assess all patients for the presence of any condition that precludes Optison administration. Always have resuscitation equipment and trained personnel readily available.

  • PLAX, Parasternal long axis
  • PSAX, Parasternal short axis
  • A4CH, Apical 4 Chamber View
  • A2CH, Apical 2 Chamber View
  1. PLAX View

  2. PSAX View

  3. A4CH View

  4. A2CH View

+

Patient Detail

2
female patient

Infective endocarditis

66

Years Old

148/87

Blood Pressure

5'5"

Height

146

Pounds

Interpretation of Unenhanced and Contrast-Enhanced Echocardiograms

Due to poor endocardial border definition, ultrasound contrast (Optison) was used.

After injection of Optison, the echocardiogram shows:

  • LV systolic function is mildly decreased
  • LV cavity size is normal
  • LV systolic thickening is normal in all segments
  • Visually estimated LVEF fraction is 50%-55%
  • Small echodensities on the lateral leaflet of the tricuspid valve and the pacemaker lead (which are likely vegetations)
  • Mildly elevated RV systolic pressure

LV, left ventricular; EF, ejection fraction; RV, right ventricular.

Important Risk and Safety Information About Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

WARNING — SERIOUS CARDIOPULMONARY REACTIONS:

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration. Assess all patients for the presence of any condition that precludes Optison administration. Always have resuscitation equipment and trained personnel readily available.

  • PLAX, Parasternal long axis
  • PSAX, Parasternal short axis
  • A4CH, Apical 4 Chamber View
  • A2CH, Apical 2 Chamber View
  1. PLAX View

  2. PSAX View

  3. A4CH View

  4. A2CH View

+

Patient Detail

3
female patient

Stroke

54

Years Old

133/64

Blood Pressure

5'5"

Height

150

Pounds

Interpretation of Unenhanced and Contrast-Enhanced Echocardiograms

Due to poor endocardial border definition, ultrasound contrast (Optison) was used.

After injection of Optison, the echocardiogram shows:

  • LV cavity size is mildly to moderately increased
  • Visually estimated LVEF is 20%-25%
    • The majority of LV segments appear severely hypokinetic
    • Systolic function is best preserved in the basal and mid-anterior and anterolateral wall, which appear as only mildly hypokinetic
  • RV size and systolic function appear normal

LV, left ventricular; EF, ejection fraction; RV, right ventricular.

Important Risk and Safety Information About Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

WARNING — SERIOUS CARDIOPULMONARY REACTIONS:

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration. Assess all patients for the presence of any condition that precludes Optison administration. Always have resuscitation equipment and trained personnel readily available.

  • PLAX, Parasternal long axis
  • PSAX, Parasternal short axis
  • A4CH, Apical 4 Chamber View
  • A2CH, Apical 2 Chamber View
  • A3CH, Apical 3 Chamber View
  1. PLAX View

  2. PSAX View

  3. A4CH View

  4. A2CH View

  5. A3CH View

+

Patient Detail

4
female patient

Heart failure

50

Years Old

95/50

Blood Pressure

5'7"

Height

249

Pounds

Interpretation of Unenhanced and Contrast-Enhanced Echocardiograms

Due to poor endocardial border definition, ultrasound contrast (Optison) was used.

After injection of Optison, the echocardiogram shows:

  • LV cavity size is normal
  • LV systolic function is mildly decreased
  • Mild concentric LV hypertrophy
  • LV systolic thickening is segmentally abnormal
  • Visually estimated LVEF is 45%-50%
  • Mid-inferolateral, mid-anterolateral, and mid-inferior segments are abnormal (hypokinetic)
  • A pacemaker lead is noted in the RV
  • There is evidence for elevated RV diastolic pressure
  • Compared with the most recent exam (about 18 months prior), the LVEF has decreased

LV, left ventricular; EF, ejection fraction; RV, right ventricle/ventricular.

Important Risk and Safety Information About Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

WARNING — SERIOUS CARDIOPULMONARY REACTIONS:

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration. Assess all patients for the presence of any condition that precludes Optison administration. Always have resuscitation equipment and trained personnel readily available.

  • PLAX, Parasternal long axis
  • PSAX, Parasternal short axis
  • A4CH, Apical 4 Chamber View
  • A2CH, Apical 2 Chamber View
  • A3CH, Apical 3 Chamber View
  1. PLAX View

  2. PSAX View

  3. A4CH View

  4. A2CH View

  5. A3CH View

+

Patient Detail

5
male patient

Chest pain, new PE

56

Years Old

101/73

Blood Pressure

5'10"

Height

155

Pounds

Interpretation of Unenhanced and Contrast-Enhanced Echocardiograms

Due to poor endocardial border definition, ultrasound contrast (Optison) was used.

After injection of Optison, the echocardiogram shows:

  • Moderate biatrial enlargement
  • RV is moderately enlarged
  • LV cavity size is severely increased
  • Severe eccentric LV hypertrophy
  • LV systolic function is severely decreased
  • Visually estimated LVEF is <20%
  • Diffusely increased trabeculation of the apical and anterolateral LV segments with myocardial crypt formation
    • The ratio of trabeculated to compact myocardium is >2.3, consistent with noncompaction cardiomyopathy
  • No significant valvular disease is present
  • Compared with a previous study (11 days prior), there has been no significant interval change, allowing for difference in patient positioning (upright at present) and a different estimate of RA pressure, estimated RVSP is comparable.

LV, left ventricular; EF, ejection fraction; RV, right ventricle; RA, right atrial; RVSP, right ventricle systolic pressure.

Important Risk and Safety Information About Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

WARNING — SERIOUS CARDIOPULMONARY REACTIONS:

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration. Assess all patients for the presence of any condition that precludes Optison administration. Always have resuscitation equipment and trained personnel readily available.

  • PLAX, Parasternal long axis
  • PSAX, Parasternal short axis
  • A4CH, Apical 4 Chamber View
  • A2CH, Apical 2 Chamber View
  • A3CH, Apical 3 Chamber View
  1. PLAX View

  2. PSAX View

  3. A4CH View

  4. A4CH View

  5. A2CH View

  6. A3CH View

+

Patient Detail

6
female patient

Preoperative, history of low EF

83

Years Old

129/45

Blood Pressure

5'1"

Height

151

Pounds

Interpretation of Unenhanced and Contrast-Enhanced Echocardiograms

Due to poor endocardial border definition, ultrasound contrast (Optison) was used.

After injection of Optison, the echocardiogram shows:

  • LV cavity size is normal
  • LV systolic function is normal
  • Visually estimated LVEF is 55%-60%

LV, left ventricular; EF, ejection fraction.

Important Risk and Safety Information About Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

WARNING — SERIOUS CARDIOPULMONARY REACTIONS:

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration. Assess all patients for the presence of any condition that precludes Optison administration. Always have resuscitation equipment and trained personnel readily available.

  • PLAX, Parasternal long axis
  • A4CH, Apical 4 Chamber View
  • A2CH, Apical 2 Chamber View
  1. A4CH View

  2. A2CH View

  3. A3CH View

+

Patient Detail

7
female patient

Heart failure, status postcardiac arrest

35

Years Old

98/45

Blood Pressure

5'0"

Height

202

Pounds

Interpretation of Unenhanced and Contrast-Enhanced Echocardiograms

Due to poor endocardial border definition, ultrasound contrast (Optison) was used.

After injection of Optison, the echocardiogram shows:

  • Mild concentric LV hypertrophy
  • LV systolic function is normal. LV is underfilled
  • Visually estimated LVEF is 70%-75%
  • Stroke volume index is severely decreased
  • Moderately reduced RV systolic function
  • Moderately elevated RV systolic pressure
  • Rheumatic mitral valve. Mild mitral stenosis
  • Compared with the most recent study (more than six years prior), there is a vast difference in stroke volume and RVSP. The MV is now abnormal

LV, left ventricular; EF, ejection fraction; RV, right ventricular; RVSP, right ventricular systolic pressure; MV, mitral valve.

Important Risk and Safety Information About Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

WARNING — SERIOUS CARDIOPULMONARY REACTIONS:

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration. Assess all patients for the presence of any condition that precludes Optison administration. Always have resuscitation equipment and trained personnel readily available.

  • PLAX, Parasternal long axis
  • PSAX, Parasternal short axis
  • A4CH, Apical 4 Chamber View
  • A2CH, Apical 2 Chamber View
  • A3CH, Apical 3 Chamber View
  1. PLAX View

  2. PSAX View

  3. A4CH View

  4. A2CH View

  5. A3CH View

+

Patient Detail

8
female patient

Hypotension, evaluate volume status, status post-PE

68

Years Old

114/49

Blood Pressure

5'3"

Height

176

Pounds

Interpretation of Unenhanced and Contrast-Enhanced Echocardiograms

Due to poor endocardial border definition, ultrasound contrast (Optison) was used.

After injection of Optison, the echocardiogram shows:

  • LV cavity size is normal
  • LV systolic function is normal
  • Visually estimated LVEF is 60%-65%
  • Moderately enlarged RV
  • Mild to moderate tricuspid regurgitation
  • Prominent and thickened moderator band. Suspect chronic elevation of pulmonary pressure
  • Hypokinesis is noted in the mid to distal RV lateral wall
  • Mildly to moderately reduced RV systolic function
  • Severely elevated RV systolic pressure
  • Reverse interventricular septal curvature consistent with elevated RV systolic and diastolic pressure

LV, left ventricular; EF, ejection fraction; RV, right ventricle/ventricular.

Important Risk and Safety Information About Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

WARNING — SERIOUS CARDIOPULMONARY REACTIONS:

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration. Assess all patients for the presence of any condition that precludes Optison administration. Always have resuscitation equipment and trained personnel readily available.

  • PLAX, Parasternal long axis
  • PSAX, Parasternal short axis
  • A4CH, Apical 4 Chamber View
  • A2CH, Apical 2 Chamber View
  • A4CH, Apical 3 Chamber View
  1. PLAX View

  2. PSAX View

  3. A4CH View

  4. A2CH View

  5. A4CH View With Emphasis on the RV

+

Patient Detail

9
male patient

Chronic heart failure, LV thrombus

80

Years Old

151/74

Blood Pressure

5'8"

Height

123

Pounds

Interpretation of Unenhanced and Contrast-Enhanced Echocardiograms

Due to poor endocardial border definition, ultrasound contrast (Optison) was used.

After injection of Optison, the echocardiogram shows:

  • LV cavity size is normal
  • LV systolic function is moderately to severely decreased
  • Calculated LVEF is 35%
  • LV apical aneurysm
  • No evidence of LV thrombus
  • Mildly elevated RV systolic pressure
  • Compared with a previous study (about six months prior), LV size and systolic function are similar. There is no evidence of thrombus in this study

LV, left ventricular; EF, ejection fraction; RV, right ventricular.

Important Risk and Safety Information About Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

WARNING — SERIOUS CARDIOPULMONARY REACTIONS:

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration. Assess all patients for the presence of any condition that precludes Optison administration. Always have resuscitation equipment and trained personnel readily available.

  • PLAX, Parasternal long axis
  • PSAX, Parasternal short axis
  • A3CH, Apical 3 Chamber View
  • A4CH, Apical 4 Chamber View
  • A2CH, Apical 2 Chamber View
  1. PLAX View

  2. PSAX View

  3. A3CH View

  4. A4CH View

  5. A2CH View

+

Patient Detail

10
male patient

Syncope and atrial fibrillation

67

Years Old

122/59

Blood Pressure

5'10"

Height

185

Pounds

Interpretation of Unenhanced and Contrast-Enhanced Echocardiograms

Due to poor endocardial border definition, ultrasound contrast (Optison) was used.

After injection of Optison, the echocardiogram shows:

  • LV cavity size is normal
  • LV systolic function is normal
  • Visually estimated LVEF is 55%-60%
  • Moderately dilated left atrium

LV, left ventricular; EF, ejection fraction.

Important Risk and Safety Information About Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

WARNING — SERIOUS CARDIOPULMONARY REACTIONS:

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration. Assess all patients for the presence of any condition that precludes Optison administration. Always have resuscitation equipment and trained personnel readily available.

  • PLAX, Parasternal long axis
  • PSAX, Parasternal short axis
  • A4CH, Apical 4 Chamber View
  • A2CH, Apical 2 Chamber View
  • A3CH, Apical 3 Chamber View
  1. PLAX View

  2. PSAX View

  3. A4CH View

  4. A2CH View

  5. A3CH View

+

Patient Detail

11
male patient

Hypertension, type 2 diabetes mellitus, obesity

67

Years Old

N/A

Blood Pressure

6'1"

Height

297

Pounds

Interpretation of Unenhanced and Contrast-Enhanced Echocardiograms

Due to poor endocardial border definition, ultrasound contrast (Optison) was used.

After injection of Optison, the echocardiogram shows:

  • LV cavity size is normal
  • LV systolic function is normal
  • Visually estimated LVEF is 60%-65%
  • Mild concentric LV hypertrophy
  • LV systolic thickening is normal in all segments

LV, left ventricular; EF, ejection fraction.

Important Risk and Safety Information About Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

WARNING — SERIOUS CARDIOPULMONARY REACTIONS:

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration. Assess all patients for the presence of any condition that precludes Optison administration. Always have resuscitation equipment and trained personnel readily available.

  • PLAX, Parasternal long axis
  • PSAX, Parasternal short axis
  • A4CH, Apical 4 Chamber View
  • A2CH, Apical 2 Chamber View
  • A3CH, Apical 3 Chamber View
  1. PLAX View

  2. PSAX View

  3. A4CH View

  4. A2CH View

  5. A3CH View

+

Patient Detail

12
male patient

Assess for wall motion abnormality

53

Years Old

118/80

Blood Pressure

6'2"

Height

272

Pounds

Interpretation of Unenhanced and Contrast-Enhanced Echocardiograms

Due to poor endocardial border definition, ultrasound contrast (Optison) was used.

After injection of Optison, the echocardiogram shows:

  • LV cavity size is normal
  • Moderate concentric LV hypertrophy
  • Visually estimated LVEF is 60%-65%

LV, left ventricular; EF, ejection fraction.

Important Risk and Safety Information About Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

WARNING — SERIOUS CARDIOPULMONARY REACTIONS:

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration. Assess all patients for the presence of any condition that precludes Optison administration. Always have resuscitation equipment and trained personnel readily available.

  • PLAX, Parasternal long axis
  • PSAX, Parasternal short axis
  • A4CH, Apical 4 Chamber View
  • A2CH, Apical 2 Chamber View
  • A3CH, Apical 3 Chamber View
  1. PLAX View

  2. PSAX View

  3. A4CH View

  4. A2CH View

  5. A3CH View

+

Patient Detail

13
male patient

CVA, Stroke

84

Years Old

94/64

Blood Pressure

5'3"

Height

138

Pounds

Interpretation of Unenhanced and Contrast-Enhanced Echocardiograms

Due to poor endocardial border definition, ultrasound contrast (Optison) was used.

  • In the unenhanced image, the LV endocardial border is poorly defined
  • Following injection of Optison, the LV surfaces and chamber are more visualized
  • After contrast, a large apical thrombus was visible

LV, left ventricular.

Important Risk and Safety Information About Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

WARNING — SERIOUS CARDIOPULMONARY REACTIONS:

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration. Assess all patients for the presence of any condition that precludes Optison administration. Always have resuscitation equipment and trained personnel readily available.

  • PLAX, Parasternal long axis
  • A4CH, Apical 4 Chamber View
  1. PLAX View

  2. A4CH View

Important Risk and Safety Information About Optison

Important Risk and Safety Information About Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

WARNING — SERIOUS CARDIOPULMONARY REACTIONS:

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration. Assess all patients for the presence of any condition that precludes Optison administration. Always have resuscitation equipment and trained personnel readily available.

INDICATIONS: 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. CONTRAINDICATIONS: Do not administer Optison to patients with known or suspected: (1) Right-to-left, bidirectional, or transient right-to-left cardiac shunts or (2) Hypersensitivity to perflutren, blood, blood products, or albumin. Do not administer Optison by intra-arterial injection. WARNINGS — Anaphylactoid Reactions: In postmarketing use, uncommon but serious anaphylactoid reactions were observed during or shortly following perflutren-containing microsphere administration, including in patients with no prior exposure to perflutren-containing microsphere products. High Ultrasound Mechanical Index: High ultrasound mechanical index values may cause microsphere cavitation or rupture and lead to ventricular arrhythmias. Additionally, end-systolic triggering with high mechanical indices has been reported to cause ventricular arrhythmias. The safety of Optison at mechanical indices greater than 0.8 and the safety of Optison with the use of end-systolic triggering have not been evaluated. PRECAUTIONS — General: Optison 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 and Creutzfeldt-Jakob disease (CJD), no cases of which have ever been identified for albumin. Pregnancy: Adequate or well-controlled studies were not conducted in pregnant women. Optison should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Optison is administered to a nursing woman. Pediatric Use: Safety and efficacy have not been established in pediatric patients or in patients with congenital heart disease. ADVERSE REACTIONS: The most frequently reported adverse reactions following clinical trial use of Optison were headache, nausea and/or vomiting, warm sensation or flushing, and dizziness. Postmarketing Experience: 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.

Prior to Optison administration, please read the Full Prescribing Information.

References

  1. Optison [prescribing information]. Princeton, NJ: GE Healthcare; 2010.
  2. Mulvagh SL, Rakowski H, Vannan MA, et al. American Society of Echocardiography Consensus Statement on the Clinical Applications of Ultrasonic Contrast Agents in Echocardiography. J Am Soc Echocardiogr. 2008;21:1179-1201.
  3. US Food and Drug Administration. Fractionated plasma products: albumin. Available at: http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm127577.htm.
    Accessed February 14, 2013.
  4. Albumin (Human) 5% Full Prescribing Information. Available at: http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM056844.pdf
    Accessed February 14, 2013
  5. Albumin (Human) 25% Full Prescribing Information. Available at: http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM056845.pdf
    Accessed February 14, 2013.
  6. Albumin therapy. Information about albumin therapy. Available at: http://www.albumintherapy.com/index.html.
    Accessed February 14, 2013.
  7. Baxter Healthcare Corporation. Albumin Therapy. Safety Profile. Available at: http://www.albumintherapy.com/albumin_therapy/safety_profile.html.
    Accessed October 15, 2012.
  8. Albumin. In: Parfitt K, ed. Martindale: The Complete Drug Reference. 32nd ed. London, UK: Pharmaceutical Press; 1999:710.
  9. M-M-R® II (Measles, Mumps, and Rubella Virus Vaccine Live) [package insert]. Whitehouse Station, NJ: Merck & Co, Inc.; 2010. Available at: http://www.merck.com/product/usa/pi_circulars/m/mmr_ii/mmr_ii_pi.pdf.
    Accessed October 15, 2012.
  10. Botox® Prescribing Information. Allergan, Inc. 2012.
  11. Albumin (Human) Full Prescribing Information. Available at: http://www.drugs.com/pro/albumin-human.html.
    Accessed October 15, 2012.
  12. Product stability data on file. GE Healthcare; 2011.
  13. Intersocietal Accreditation Commission. IAC Standards and Guidelines for Adult Echocardiography Accreditation. Available at: http://www.intersocietal.org/echo/standards/IACAdultEchocardiographyStandardsJuly2013.pdf.
    Accessed September 10, 2013.
  14. Podell S, Burrascano C, Gaal M, Golec B, Maniquis J, Mehlhaff P. Physical and biochemical stability of Optison, an injectable ultrasound contrast agent. Biotechnol Appl Biochem. 1999 Dec;30 (Pt 3):213-23.
  15. Podell S. Golec B, Lohrmann, R. Measuring the effects of ultrasound on contrast agents. In: Ultrasonics Symposium, 1999. Proceedings. 1999 IEEE (Volume 2).

Botox is a registered trademark of Allergan, Inc.

M-M-R is a registered trademark of Merck & Co., Inc.