Healthcare Industry News: cardiac monitor
News Release - December 21, 2007
GE Healthcare Announces Expansion of Nuclear Cardiology Portfolio for Medical Diagnostics BusinessPRINCETON, N.J.--(HSMN NewsFeed)--GE Healthcare, the worldwide leader in Diagnostic Imaging Technologies, announced today that it has entered into an agreement with DRAXIMAGE, a division of DRAXIS Health Inc. (NASDAQ:DRAX ) (TSX:DAX ) of Montreal, Canada, to become the exclusive distributor of DRAXIMAGE® Sestamibi upon its approval by the U.S. Food and Drug Administration (FDA) and the expiration of the primary innovator patent. An abbreviated New Drug Application (ANDA) for DRAXIMAGE® Sestamibi was submitted by DRAXIMAGE to the FDA in February 2007, and is currently under review.
“We are delighted to announce this agreement, and continue to expand our portfolio of diagnostic imaging products through our North American radiopharmacy network,” said John Chiminski, President & CEO of GE Healthcare’s Medical Diagnostics division. “Our expertise in Nuclear Cardiology as the innovator of Myoview makes us ideally suited to make this new product available through our Radiopharmacy Operation that has the highest standards in the industry.”
Technetium-labeled radiopharmaceuticals, which include Myoview™ (Kit for the Preparation of Technetium Tc99m Tetrofosmin for Injection), are used in approximately 90% of nuclear medicine studies performed to detect coronary artery disease. Over eight million patients receive myocardial perfusion imaging each year, as the increasing rates of obesity, diabetes, and hypertension (heart failure) continue to contribute to disease progression. According to the American Heart Association, coronary artery disease is responsible for more than half of the deaths associated with cardiovascular diseases (2006).
“Nuclear Cardiology is a proven technology, and we’re confident that our partnership with DRAXIMAGE will expand the access to and applicability of these procedures when and where they are needed. This agreement further demonstrates our commitment to Nuclear Medicine, through outstanding Radiopharmacy performance and the broadest product portfolio in the industry,” Chiminski added.
ABOUT GE HEALTHCARE:
GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.
GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE:GE ). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com.
DRAXIMAGE, a division of DRAXIS Health Inc., develops, manufactures and markets diagnostic and therapeutic radiopharmaceuticals for the global marketplace. Products currently include a line of lyophilized technetium-99m kits used in nuclear medicine imaging procedures and therapeutic products labeled with a variety of isotopes including radioiodine.
MYOVIEW™ (Kit for the Preparation of Technetium Tc99m Tetrofosmin for Injection)
In studying patients with known or suspected coronary artery disease, care should be taken to ensure continuous cardiac monitoring and the availability of emergency cardiac treatment. As with all injectable drug products, allergic reactions, and anaphylaxis may occur.
Pharmacologic induction of cardiovascular stress may be associated with serious adverse events, such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, and cerebrovascular events. Caution should be used when pharmacologic stress is selected as an alternative to exercise; it should be used when indicated and in accordance with the pharmacologic stress agent's labeling. The most common adverse reactions reported from post-marketing experience with MYOVIEW included rash, urticaria, abnormal vision, allergic reactions, and fever.
Source: GE Healthcare
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