Lantheus Medical Imaging, Inc. Announces Magnetic Resonance Angiography (MRA) Contract Award for ABLAVAR® With Amerinet, Inc.
--First and Only Blood Pool Imaging Agent Approved for Use With
MRA in the U.S. Will be Available to More Than 27,000 Acute and Alternate Care Sites Nationwide--
N. BILLERICA, Mass. (June 3, 2010) – Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medical imaging, today announced the first national contract signed for ABLAVAR® with Amerinet, Inc., a leading national healthcare group purchasing organization. ABLAVAR® (gadofosveset trisodium), is a unique, injectable MRA blood pool imaging agent indicated to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease (PVD). The agreement, effective May 1, 2010, makes ABLAVAR® available nationally to all Amerinet members and was awarded based on the fact that ABLAVAR® is the first and only FDA approved blood pool contrast agent for use with an MRA indication. Amerinet has more than 2,500 acute care hospitals and 25,000 alternate care members in its network of healthcare providers.
“We are pleased that Amerinet, one of the nation’s largest group purchasing organizations, recognizes the diagnostic value that ABLAVAR® can provide to the patients and physicians in their network and that they have entered into this distribution agreement with Lantheus Medical Imaging,” said Robert Spurr, Vice President, Sales and Marketing at Lantheus Medical Imaging. “ABLAVAR® is clinically proven to produce high resolution images and is uniquely designed for vascular imaging, making it possible for physicians to detect vascular disease less invasively than with conventional X-ray angiography. Additionally, the product requires no radiation or iodine and can provide both first pass and blood pool images with a single, low dose injection.”
Blood pool agents remain in the vasculature for an extended period of time, increasing the brightness of blood, resulting in high-resolution images. The albumin-binding properties of ABLAVAR® make it uniquely designed for vascular imaging because it provides an expanded imaging window, making it possible to evaluate not only the location of disease but the extent and severity of disease.
About ABLAVAR® (gadofosveset trisodium)
ABLAVAR® is the first and only blood pool contrast agent approved for magnetic resonance angiography to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease. The albumin-binding properties of ABLAVAR® make it uniquely designed for vascular imaging, allowing multiple images to be obtained using a single, low dose injection. ABLAVAR® is clinically proven to produce high resolution MRA images, combining both dynamic (first pass) and steady state imaging, resulting in diagnostic accuracy comparable to conventional X-ray angiography1,2, the current standard of care for diagnosing vascular disease such as AIOD. Gadofosveset trisodium is approved in 37 countries outside the United States and has been used in nearly 90,000 patients to date3. Lantheus owns the rights to ABLAVAR® in the United States, Canada and Australia.
ABLAVAR® is indicated for use as a contrast agent in magnetic resonance angiography (MRA) to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease.
History of a prior allergic reaction to a gadolinium-based contrast agent.
Important Safety Information:
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
In these patients, avoid use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle, and internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. When administering a gadolinium-based contrast agent, do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent from the body prior to any re-administration.
ABLAVAR® Injection: 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. As with other paramagnetic contrast agents, caution should be exercised in patients with renal insufficiency due to the possibility of further deterioration in renal function.
In clinical trials, a small increase (2.8 msec) in the average change from baseline in QTc was observed at 45 minutes. These QTc prolongations were not associated with arrhythmias or symptoms. Caution should be used in patients at high risk for arrhythmias due to baseline QTc prolongation.
Have emergency resuscitative equipment available prior to and during ABLAVAR® administration.
Please see full Prescribing Information, including boxed WARNING regarding Nephrogenic Systemic Fibrosis (NSF), at www.ablavar.com.
As a leading national healthcare group purchasing organization, Amerinet strategically partners with acute and alternate care providers to reduce costs and improve quality through its performance solutions. Built on a foundation of data, savings and trust, and supported by a team of clinical and supply chain experts, Amerinet enriches healthcare delivery for its members and the communities they serve. To learn more about the Amerinet difference, visit www.amerinet-gpo.com.
About Lantheus Medical Imaging, Inc.
Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medicine for more than 50 years, is dedicated to creating and providing pioneering medical imaging solutions to improve the treatment of human disease. The company’s proven success in discovering, developing and marketing innovative medical imaging agents provides a strong platform from which to bring forward breakthrough new tools for the diagnosis and management of disease. Lantheus imaging products include the echocardiography contrast agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension, ABLAVAR® (gadofosveset trisodium), a first-in-class magnetic resonance agent indicated for the evaluation of aortoiliac occlusive disease in adults with known or suspected peripheral vascular disease, TechneLite® (Technetium Tc99m Generator), Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), and Thallium 201 (Thallous Chloride Tl 201 Injection). Lantheus has more than 600 employees worldwide with headquarters in North Billerica, Massachusetts, and offices in Puerto Rico, Canada and Australia. For more information, visit www.lantheus.com.
1. Goyen, M, Edelman, M, Perreault, P, et al. MR Angiography of Aortoiliac Occlusive Disease: A Phase III Study of the Safety and Effectiveness of the Blood-Pool Contrast Agent MS-325. Radiology. 2005; 236(3):825-833.
2. Rapp, JH, Wolff, SD, Quinn, SF, et al. Aortoiliac Occlusive Disease in Patients with Known or Suspected Peripheral Vascular Disease: Safety and Efficacy of Gadofosveset-Enhanced Angiography – Multicenter Comparative Phase III Study. Radiology. 2005; 236(1):71-78.
3. Data on file, Lantheus Medical Imaging, Inc.