[This entry is marked for removal.]

From POINT Biomedical Corp
CARDIOsphere® is an ultrasound contrast agent for assessment of myocardial perfusion in patients with coronary artery disease composed of highly echogenic bispheres.
PB127 is a new developed microbubble with a bilayer polymer/albumin shell filled with nitrogen gas that has ideal characteristics for power harmonic Doppler. They can be destroyed by high power ultrasound, and spectral decorrelation between ultrasound pulses is maximized by rapid dissolution of the released nitrogen gas.
POINT Biomedical Corp. announced (March 01, 2004) that it has completed two Phase 3 trials of CARDIOsphere®. The Phase 3 trials were designed to evaluate the performance of CARDIOsphere® imaging relative to radionuclide imaging for detecting obstructive coronary artery disease and identifying the anatomic location of perfusion defects.

Diagnostic ultrasound imaging has no known risks or long-term side effects. Discomfort to the patient is very rare if the sonogram is accurately performed by using appropriate frequencies and intensity ranges. However, the application of the ALARA principle is always recommended.
There are reports of low birth weight of babies after applying more than the recommended ultrasound examinations during pregnancy. Women who think they might be pregnant should raise this issue with the doctor before undergoing an abdominal ultrasound, to avoid any harm to the fetus in the early stages of development.
Since ultrasound is energy, sensitive tissues like the reproductive organs could possibly sustain damage if vibrated to a high degree by too intense ultrasound waves. In diagnostic ultrasonic procedures, such damage would only result from improper use of the equipment.

Possible ultrasound bioeffects:
The thermal effect is controlled by the displayed thermal index and the mechanical index indicates the risk of cavitation.
An ultrasound gel is applied to obtain better contact between the transducer and the skin. This has the consistency of thick mineral oil and is not associated with skin irritation or allergy.
Specific conditions for which ultrasound may be selected as a treatment may be attached with higher risks.

See also Ultrasound Imaging Procedures, Fetal Ultrasound and Obstetric and Gynecologic Ultrasound.

From Bayer Schering Pharma AG:
Available in Europe since 1996 and in Japan since 1999. Currently, the marketing situation is unclear.
Levovist® is a first generation USCA consisting of galactose (milk sugar) ground into tiny crystals whose irregular surfaces act as nidation sites on which air pockets form when it is suspended in water, much as soda water bubbles form at small irregularities on the surface of the glass. A trace of palmitic acid is added as a surfactant to stabilize the resultant microbubbles. When Levovist® dissolves in blood, air trapped inside the galactose is released as free gas bubbles. These bubbles have a weak encapsulating shell and are easily destroyed by ultrasound.
Different contrast ultrasonography methods have been developed since the introduction of Levovist®. Initially, Levovist® was an echo contrast medium for improving sensitivity in color Doppler and Power Doppler examinations, but was found to suffer from significant blooming, making it difficult to observe small blood vessels. However, Levovist® improves the accuracy of echocardiographic examinations in such indications as assessment of left ventricular function.
In addition to their vascular phase, some ultrasound contrast agents (USCAs) can exhibit a tissue- or organ-specific phase. Levovist® can accumulate within the liver and the spleen for up to 20 min once it has disappeared from the blood pool and improves the detectability of focal liver lesions and allows more reliable control of interventional tumor treatments. Varied types of information can be obtained by applying contrast imaging at different times after the injection using Levovist® in both the arterial phase and the late organ-specific phase.
1 g Levovist® granules contain 999 mg D-galactose and 1 mg palmitic acid.
Brand names in other countries: Levovist/Levograf

From GE Healthcare;;
Optison is the first 'second generation USCA' marketed in the US.
Ultrasound contrast agents used during an ultrasound imaging procedure, enable more accurate diagnosis of the patient's heart condition. The application of Optison allows to image the endocardial borders of the heart, to see cardiac wall motion abnormalities and to guide the selection and monitoring of treatment.
Optison represents a class of microbubbles with a shell formed by sonicating a solution of capsules filled with a perfluoropropane gas. The high molecular weight slows microbubble dissolution and prolongs the enhancement for several minutes. The human albumin-stabilized cavitation bubbles have a surface tension of 0.9 N/m and a surface dilatational viscosity 0.08 msP.

'August 06, 2001 Molecular Biosystems Inc., a subsidiary of Alliance Pharmaceutical Corp, announced the amendment of the Optison Product Rights Agreement (OPRA) dated May 9, 2000 with Mallinckrodt Inc, a unit of Tyco Healthcare. Optison, an intravenous ultrasound contrast agent, was developed by MBI and is being marketed by Mallinckrodt in the U.S. and Europe. Under the amended agreement, MBI will receive an immediate cash payment plus additional unspecified royalties for a two-year period. The amendment of OPRA coincides with an announcement by Nycomed Amersham Imaging that Nycomed and Mallinckrodt will terminate their joint commercialization and development agreement for ultrasound contrast agents, including Optison, effective Dec. 31, 2001. Effective Jan. 1, 2002, all selling and marketing activities will be resumed solely by Nycomed Amersham.'

From Lantheus Medical Imaging.
Activated DEFINITY® Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. The perflutren lipid microspheres exhibit lower acoustic impedance than blood and enhance the intrinsic backscatter of blood.
Echocardiography with Definity produced more detailed images of the heart in difficult-to-image patients versus echocardiography alone, and images obtained with the contrast agent provided a more accurate assessment of segmental wall motion compared with unenhanced images.

See also Coherent Contrast Imaging.

In August 2001 DuPont Pharmaceuticals Company received FDA approval.