Lantheus Medical Imaging announces the launch of ABLAVAR

Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic imaging, today announced the launch of ABLAVAR™ (gadofosveset trisodium), a unique, injectable MRA imaging agent used to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease (PVD). ABLAVAR™ is the first and only contrast imaging agent approved in the United States for use with a magnetic resonance angiography (MRA) indication to evaluate AIOD. AIOD is a type of PVD that occurs when arteries, which carry blood from the heart to the lower limbs, become narrowed or blocked. This lack of blood supply can result in pain, infection and even loss of limbs.

“ABLAVAR™ may provide clinicians performing vascular imaging with more comprehensive, three-dimensional diagnostic information to improve patient treatment decisions and care”

In Phase 3 clinical studies, ABLAVAR™ demonstrated statistically greater sensitivity (detecting disease when present) compared with non-contrast MRA. These studies, which supported the U.S. Food and Drug Administration (FDA) approval of ABLAVAR™, show that MRA images using ABLAVAR™ provided diagnostic accuracy comparable to conventional X-ray angiography, an invasive procedure which involves insertion of a catheter into the arteries in the upper thigh (groin area) or arm.

“ABLAVAR™ provides distinct advantages over X-ray angiography, the current standard of care in diagnosing AIOD,” said Mark G. Hibberd, M.D., Ph.D., Senior Medical Director, Global Medical Affairs, Lantheus Medical Imaging, Inc. “ABLAVAR™ provides high resolution images comparable to conventional X-ray angiography (the current gold standard), which offers radiologists a clear, enhanced visualization of patients’ arteries. However, ABLAVAR™ is given in a single, low dose injection, does not require catheter insertion into a patient’s arteries, and does not expose patients to ionizing radiation, all of which are tangible benefits to patients.”

“ABLAVAR™ may provide clinicians performing vascular imaging with more comprehensive, three-dimensional diagnostic information to improve patient treatment decisions and care,” added E. Kent Yucel, M.D., FACR, Chairman of Radiology, Tufts Medical Center. “ABLAVAR™, as the first FDA-approved contrast agent for an MRA indication, is a welcome addition to the currently available options for diagnosing AIOD in patients with known or suspected peripheral vascular disease.”

“We are pleased to realize our goal of launching ABLAVAR™, as it can provide patients and clinicians with the first and only product that is approved by the FDA for use with an MRA indication and is specifically indicated for detecting aortoiliac occlusive disease,” said Don Kiepert, President and CEO of Lantheus Medical Imaging, Inc. “With the introduction of this first-in-class imaging agent, we extend our presence into the radiology and peripheral vascular disease markets, and expand our portfolio of diagnostic imaging agents to now include MRI as well as SPECT, PET and echocardiography imaging modalities.”