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EPIX Pharmaceuticals announces FDA Approval of Vasovist(R) (gadofosveset trisodium), the first imaging agent approved for MRA
| Company News - EPIX Pharmaceuticals |
Vasovist will be well-received by the physician community as a valuable, safe tool for MRA
Epix Pharmaceuticals Inc. has announced that the U.S Food and Drug Administration (FDA) has approved for marketing its novel blood pool magnetic resonance angiography (MRA) agent, Vasovist® (gadofosveset trisodium), to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease.
EPIX Pharmaceuticals is a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform.
Aortoiliac occlusive disease (AIOD) occurs when iliac arteries become narrowed or blocked. Arteries are normally smooth and unobstructed on the inside, but with age, plaque can build up in the walls of arteries and cause them to narrow and stiffen. Those affected with AIOD may not receive the blood and oxygen they need throughout their legs, causing pain, sores or gangrene, which can result in the loss of a limb. Peripheral vascular disease refers to diseases of blood vessels outside the heart and brain and includes functional peripheral vascular disease, which doesn't have an organic cause or involve defects in blood vessels' structure and organic peripheral vascular disease, which is caused by structural changes in blood vessels.
Vasovist is the first Imaging agent approved for marketing in the U.S for use with Magnetic Resonance Angiography (MRA), a non-invasive modality for imaging blood vessels. It is an injectable intravascular contrast agent designed to provide improved imaging of the vascular system through magnetic resonance angiography imaging (MRA). Vasovist had previously been approved for marketing in 34 countries outside the United States. Vasovist is currently marketed in Canada and 18 European countries, including Germany, the Netherlands, Italy, all Nordic countries, the United Kingdom and Switzerland.
MRA is a less invasive procedure than x-ray angiography, allowing for reduced patient discomfort and recuperation time and unlike x-ray angiography, MRA does not expose patients to ionizing radiation. It uses a powerful magnetic field, radio waves and a computer to produce detailed images of major blood vessels throughout the body. MRA may be performed with or without contrast material and is used in many diagnostic medical procedures including the identification of disease, aneurysms, and atherosclerosis; it is also used to guide surgeons making repairs to diseased blood vessels and plans for surgical operations.
"Vasovist is a first-in-class contrast agent with several unique characteristics that we believe will allow it to become a market leader in the United States," said Elkan Gamzu, Ph.D., interim chief executive officer of EPIX. Our strategy remains to monetize this asset and we believe these characteristics and market dynamics make Vasovist an appealing opportunity for a company interested in building or augmenting its competitive position in the imaging market."
Vasovist offers good resolution angiography, a high signal per dose, a long imaging window timeframe and single-dose imaging of multiple vessel beds. Vasovist will allow physicians to fully utilize MRA as a meaningful diagnostic and therapeutic tool.
Source: Epix Pharmaceuticals Inc.
EPIX Pharmaceuticals is a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform.
Aortoiliac occlusive disease (AIOD) occurs when iliac arteries become narrowed or blocked. Arteries are normally smooth and unobstructed on the inside, but with age, plaque can build up in the walls of arteries and cause them to narrow and stiffen. Those affected with AIOD may not receive the blood and oxygen they need throughout their legs, causing pain, sores or gangrene, which can result in the loss of a limb. Peripheral vascular disease refers to diseases of blood vessels outside the heart and brain and includes functional peripheral vascular disease, which doesn't have an organic cause or involve defects in blood vessels' structure and organic peripheral vascular disease, which is caused by structural changes in blood vessels.
Vasovist is the first Imaging agent approved for marketing in the U.S for use with Magnetic Resonance Angiography (MRA), a non-invasive modality for imaging blood vessels. It is an injectable intravascular contrast agent designed to provide improved imaging of the vascular system through magnetic resonance angiography imaging (MRA). Vasovist had previously been approved for marketing in 34 countries outside the United States. Vasovist is currently marketed in Canada and 18 European countries, including Germany, the Netherlands, Italy, all Nordic countries, the United Kingdom and Switzerland.
MRA is a less invasive procedure than x-ray angiography, allowing for reduced patient discomfort and recuperation time and unlike x-ray angiography, MRA does not expose patients to ionizing radiation. It uses a powerful magnetic field, radio waves and a computer to produce detailed images of major blood vessels throughout the body. MRA may be performed with or without contrast material and is used in many diagnostic medical procedures including the identification of disease, aneurysms, and atherosclerosis; it is also used to guide surgeons making repairs to diseased blood vessels and plans for surgical operations.
"Vasovist is a first-in-class contrast agent with several unique characteristics that we believe will allow it to become a market leader in the United States," said Elkan Gamzu, Ph.D., interim chief executive officer of EPIX. Our strategy remains to monetize this asset and we believe these characteristics and market dynamics make Vasovist an appealing opportunity for a company interested in building or augmenting its competitive position in the imaging market."
Vasovist offers good resolution angiography, a high signal per dose, a long imaging window timeframe and single-dose imaging of multiple vessel beds. Vasovist will allow physicians to fully utilize MRA as a meaningful diagnostic and therapeutic tool.
Source: Epix Pharmaceuticals Inc.
Tags: EPIX Pharmaceuticals - MRA - Aortoiliac occlusive disease - AIOD - angiography - diagnostic - therapeutic tool - radiology imaging - news - education - radiology products - RSNA reviews - Reports and radiology information
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