ABLAVAR™ (formerly named Vasovist™) is a blood pool agent for magnetic resonance angiography (MRA), which opens new medical imaging possibilities in the evaluation of aortoiliac occlusive disease (AIOD) in patients with suspected peripheral vascular disease.
ABLAVAR™ binds reversibly to blood albumin, providing imaging with high spatial resolution up to 1 hour after injection, due to its high relaxivity and to the long lasting increased signal intensity of blood.
As with other contrast media: the possibility of serious or life-threatening anaphylactic or anaphylactoid reactions, including cardiovascular, respiratory and/or cutaneous manifestations, should always be considered.

WARNING:
NEPHROGENIC SYSTEMIC FIBROSIS Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with acute or chronic severe renal insufficiency (glomerular filtration rate less than 30 mL/min/1.73m²), or acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.

See also Cardiovascular Imaging, Adverse Reaction, Molecular Imaging, and MRI Safety.

Lantheus Medical Imaging is a worldwide leader in medical imaging, with headquarters in North Billerica, Massachusetts, and nearly 700 employees worldwide with offices in Puerto Rico, Canada, and Australia.
The product portfolio includes ABLAVAR™ (gadofosveset trisodium) a blood pool contrast agent for magnetic resonance angiography MRA, Cardiolite® (Kit for the preparation of Technetium Tc99m Sestamibi), a cardiac perfusion imaging agent and DEFINITY® Vial for (Perflutren Lipid Microsphere) injectable suspension, the leading cardiac ultrasound contrast agent in the US.

MRI Contrast Agents:

Vasovist™ is an albumin-targeted intravascular contrast agent. It is indicated for contrast enhanced MR angiography (CE-MRA) for the visualization of abdominal or limb vessels in patients with suspected or known vascular disease. After IV injection, Vasovist™ binds reversibly to human albumin in plasma, which results in long-lasting increased relaxivity. Imaging from 5 to 50 min is possible. A small unbound portion is, by glomerular filtration, eliminated by the kidneys.
AngioMARK® was the formerly trade name and MS-325 the research name. Currently the phase III clinical trials are completed to determine its efficacy for peripheral vascular disease and coronary artery disease.
In the U.S., EPIX received an approvable letter from the U.S. Food and Drug Administration (FDA) for Vasovist™ in January 2005. In 2009, Epix Pharmaceuticals has sold the U.S., Canadian and Australian rights for its blood pool agent (now named ABLAVAR™), to Lantheus Medical Imaging, Inc..

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with acute or chronic severe renal insufficiency (glomerular filtration rate less than 30 mL/min/1.73m²), or acute renal insufficiency of any severity due to the hepato-renal syndrome or the liver transplantation period.

See also MRI Safety.

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(July 20, 2009 - EPIX Pharmaceuticals, Inc. announced today that, in light of the company's lack of capital and inability to obtain additional financing or consummate a strategic transaction, it has entered into an Assignment for the Benefit of Creditors, effective immediately, in accordance with Massachusetts law).
EPIX has been a specialty pharmaceutical firm developing targeted contrast agents to improve the capability of MRI as a diagnostic tool for a variety of diseases. Gadofosveset trisodium (formerly MS-325, Vasovist™, now ABLAVARt™), is an injectable intravascular contrast agents designed for multiple vascular imaging applications, including peripheral vascular disease and coronary artery disease. EPIX conducted a pivotal Phase III trial for the detection of peripheral vascular disease, as well as a Phase II feasibility trial for coronary artery disease diagnosis.
To ensure rapid development and adoption of gadofosveset trisodium into clinical practice upon regulatory approval, EPIX pursued an aggressive product development plan and commercialization strategy. The Company established an exclusive, worldwide sales and marketing agreement with Bayer Schering Pharma AG. EPIX also established corporate collaborations with GE Healthcare, Philips Medical Systems and Siemens Medical Systems, the three leading MRI manufacturers, which together account for approximately 80 percent of the MRI machines installed worldwide.
EPIX had other MRI contrast agents under development, most significantly a novel prototype blood clot agent (EP-2104R). Potential clinical applications for this type of agent include detection of deep venous thrombosis, pulmonary embolism and blood clots in the coronary and carotid arteries. Currently, there is no high resolution imaging technique to directly visualize blood clots in patients with suspected cardiovascular disease.