Medical Ultrasound Imaging
Wednesday, 11 December 2024
 Info Sheets  Out- side     | 'Myocardial Perfusion' Searchterm 'Myocardial Perfusion' found in 15 articles 15 definitions [ • ] Result Pages : •
[This entry is marked for removal.] From Acusphere Inc AI-700 (trade name Imagify™) is an US contrast agent, usable for myocardial perfusion undergoing regulatory FDA approval. The synthetic polymers used in AI-700 (perflubutane polymer microspheres) do not break during the ultrasound imaging procedure. The used perfluorocarbon filling gas is less soluble in water and therefore has the propensity to stay inside the contrast agent particles. As a result, a higher concentration of gas is delivered to the myocardium over a longer period of time, thereby enabling AI-700 to target the broader application of myocardial perfusion assessment. Imagify is a dry powder consisting of small, porous microparticles filled with perfluoropropane. These microparticles are made of a synthetic biodegradable polymer, called poly (D, L-lactide co-glycolide), or PLGA, that has been used in other drug delivery systems approved by the FDA. The composition and structure of the phospholipid containing microparticles and the properties of the perfluorocarbon gas slow the rate at which the gas dissolves and prevent the microparticles from being quickly broken down. The powder is to suspend in sterile water and injected by a single intravenous injection prior to ultrasound imaging. In 2009, Acusphere Inc received feedback from the Food and Drug Administration (FDA) to their New Drug Application (NDA) stating that another clinical trial would be required for U.S. approval, this one demonstrating that Imagify with ultrasound is superior to ultrasound without Imagify. In June 2004, Acusphere entered into a Collaboration, License and Supply Agreement with Nycomed Danmark APS for the European development and marketing rights to Acusphere's lead product candidate AI-700. Acusphere's focus will be on preparing the Marketing Authorization Application (MAA) for filing in Q4 2010, building upon the work that the previous partner, Nycomed, had done, in concert with the NDA. In 2008 the FDA panel rejected the regulatory application for AI-700 (Imagify™) because of safety concerns.  Further Reading: News & More:
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[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.
Drug Information and Specification
RESEARCH NAME
PB 127
DEVELOPER
INDICATION -
DEVELOPMENT STAGE Myocardial perfusion -
Phase 3 completed APPLICATION
Infusion
TYPE
Microbubble
Polylactide/Albumin
CHARGE
Slight Negative
Nitrogen
PREPARATION
Reconstitute with 2ml H2O per vial and dilute with 150 ml DSW
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Myomap is an investigational ultrasound contrast agent for assessment of myocardial perfusion and has been tested in animals to determine infarct volumes in cases of coronary artery occlusion. The deposit microbubbles of Myomap consist of air filled human serum albumin microcapsule with a thick and rigid shell.
Drug Information and Specification
RESEARCH NAME
AIP 201
DEVELOPER
Andaris Ltd. (acquired by Quadrant)
INDICATION -
DEVELOPMENT STAGE APPLICATION
Intravenous injection
TYPE
Microbubble
Human serum albumin
CHARGE
-
Air
MICROBUBBLE SIZE
-
PREPARATION
Reconstitute with water
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(Perfluorocarbon exposed sonicated dextrose albumin) PESDA are sonicated dextrose albumin microbubbles containing decafluorobutane gas. PESDA is a sonicated self made contrast agent and not a commercial product. PESDA microbubbles can be used as a blood pool contrast agent in echocardiography to improve the detection of myocardial perfusion abnormalities.
Drug Information and Specification
RESEARCH NAME
-
DEVELOPER
-
INDICATION -
DEVELOPMENT STAGE APPLICATION
Intravenous injection
TYPE
Microbubble
Albumin / dextrose
CHARGE
-
Decafluorobutane
MICROBUBBLE SIZE
Mean: 4.7 ± 0.2 μm
PREPARATION
-
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EchoGen® is a fluorocarbon-based (dodecafluoropentane) third generation USCA. EchoGen® consists of microbubbles stabilized with surfactants in a phase shift colloid emulsion (perflenapent). EchoGen® requires no preparation, reconstitution, or refrigeration.
Perflenapent emulsion would represent a significant advance in contrast echocardiography caused by effective and long lasting opacification of the left ventricle and enhanced endocardial border delineation. The persistence of the contrast effect permits interrogation in multiple echocardiographic views, as well as the visualization and localization of myocardial perfusion deficits at rest by producing a negative contrast effect. October 12, 2000 Sonus Pharmaceuticals, Inc. announced a strategic decision to refocus the Company on the development of its drug delivery and blood substitute products. At the same time, Sonus has withdrawn the NDA (New Drug Application) and discontinued clinical activity for its ultrasound contrast product, EchoGen®. August 06, 2001 Sonus Pharmaceuticals, Inc. announced that it has entered into an agreement to sell its ultrasound contrast assets for $6.5 million to Amersham plc. As part of the agreement, Sonus has also assigned to Nycomed its interest in the ultrasound contrast patent license agreement entered into with Chugai Pharmaceutical Co. Ltd. and Molecular Biosystems Inc in January 2001.
Drug Information and Specification
RESEARCH NAME
QW3600
DEVELOPER
INDICATION -
DEVELOPMENT STAGE APPLICATION
Intravenous
TYPE
Microbubble
-
CHARGE
Negative
Dodecafluoropentane
MICROBUBBLE SIZE
-
PRESENTATION
-
STORAGE
Refrigerate 2−8 °C
PREPARATION
Finished product
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[last update: 2023-11-06 01:42:00]