Phase 3 Results for GE Healthcare Imaging Agent Flutemetamol Presented at American Academy of Neurology Meeting

NEW ORLEANS, Apr 25, 2012 (BUSINESS WIRE) -- GE Healthcare today announced results from four pooled brain biopsy studies, as well as key results from a brain autopsy study, of the investigational PET amyloid imaging agent, [(18)F]flutemetamol.(1) The data showed that both biopsy and autopsy study images had high sensitivity and specificity, and that strong concordance exists between [(18)F]flutemetamol PET images and Alzheimer's disease-associated beta amyloid brain pathology. The data confirm the potential of [(18)F]flutemetamol as an imaging agent to detect beta amyloid plaque, a pathology associated with Alzheimer's disease (AD), in living patients.

These data are being presented as part of the Emerging Science Program (formerly known as Late-Breaking Science) at the American Academy of Neurology's 64th Annual Meeting in New Orleans, April 21 to April 28, 2012, and support an application for regulatory approval of [(18)F]flutemetamol, which is intended to be filed later this year. [(18)F]flutemetamol is a GE Healthcare PET imaging agent in development for the detection of beta amyloid.

"Currently, the standard for definitively confirming AD is through detection of pathology, including amyloid plaque in the brain during autopsy," said David Wolk, MD, Assistant Professor of Neurology in the Cognitive Neurology Division, Department of Neurology, University of Pennsylvania, presenter and lead investigator for the biopsy study.

GE Healthcare


New BIOTRONIK ICD and CRT-D Series Gives Patients First-Ever Access to MR Scans

BERLIN, Germany, April 12, 2012 — BIOTRONIK, a leading manufacturer of innovative medical technology, announced today the European full market release of the new Lumax 740 ICDs (implantable cardiac defibrillators) and CRT-Ds (cardiac resynchronization therapy defibrillators) in the European market. The Lumax 740 is the world’s first and only ICD and CRT-D series approved for magnetic resonance imaging (MRI)1, now giving ICD and CRT-D patients access to vital MR scans with BIOTRONIK’s innovative ProMRI® technology.

“With its new Lumax 740 series BIOTRONIK is offering physicians and their patients access to state of the art diagnostics and the freedom to select the optimal ICD system for each patient’s indication. The development of the new ProMRI® technology really represents a significant improvement in patient care,” commented Professor Dr. Wilhelm Haverkamp, Charité University Hospital Berlin, Virchow-Clinic Campus, Germany.

Currently patients with standard ICDs are not allowed to have MR scans for safety reasons, yet 50–75% of them will be indicated for an MR scan during the lifetime of their device.2 Worldwide, the population of patients who need an ICD is growing at a rate of about 10–15% annually. At the same time, the need for MR scans is also increasing at a rate of about 10% each year. Approximately 30 million scans were performed in 2006, and in 2010, there were already about 50 million MR scans conducted worldwide.

source: Biotronik


Siemens Announces First Integrated Amyloid Imaging Solution in the U.S. Market for Use in Evaluation of Alzheimer’s Disease and Other Causes of Cognitive Decline

Hoffman Estates, Ill., April 10, 2012 — Siemens Healthcare is the first company worldwide to announce a complete integrated diagnostic imaging solution proposed for the detection of amyloid plaques — one of the necessary pathological features of Alzheimer’s disease1,2,3 — in the living brain. The latest elements of Siemens’ integrated solution came today with the company’s U.S. Food and Drug Administration (FDA) 510(k) application for its syngo®.PET Amyloid Plaque4 proprietary neurology quantification software, as well as the recent FDA approval of Eli Lilly and Company’s Amyvid™ (Florbetapir F 18 Injection), a radioactive diagnostic agent indicated for brain imaging of beta-amyloid plaques in patients with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.5

Siemens integrated amyloid imaging solution encompasses three unique elements — the new Biograph mCT™ PET•CT scanner, FDA 510(k)-pending syngo.PET Amyloid Plaque neurology quantification software and the manufacturing and distribution of Amyvid. All are examples of Siemens Healthcare’s innovative power and competitiveness, which are two goals of the company’s global initiative, Agenda 2013.

As the largest producer and distributor of Amyvid, PETNET Solutions, Siemens’ network of PET drug manufacturing establishments, will begin supplying Amyvid to imaging centers in limited U.S. markets beginning in June 2012. Complementing the new radioactive diagnostic agent, Siemens pending software could potentially support the quantification of amyloid plaque in the brain. Combined with the company’s family of high-resolution PET imaging scanners, Siemens now announces for the first time an integrated diagnostic tool for patients with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.

source: Siemens


FDA approves imaging drug Amyvid for PET scanning

The U.S. Food and Drug Administration today approved Amyvid (Florbetapir F 18 Injection) a drug for Positron Emission Tomography (PET) imaging of the brain in adults who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline. Cognitive decline refers to a condition where the ability to think and form clear, rational thoughts and decisions has decreased. It can cause an individual to lose touch with reality, oneself, other people, and external events and surroundings.

Amyvid is used to produce PET scans that estimate the brain β-amyloid neuritic plaque density in patients with cognitive impairment. β-amyloid protein is a type of protein that forms in patients with AD and some other cognitive disorders. Neuritic plaques, also called amyloid plaques, are abnormal clumps of brain cells mixed with β-amyloid protein. A negative Amyvid scan indicates few to no neuritic plaques and reduces the likelihood that any cognitive impairment is due to AD. A positive scan indicates moderate to frequent plaques. This amount of β-amyloid plaque can be found in patients with AD, in patients with other types of cognitive impairment, and in older people with normal cognition.

“Many Americans undergo evaluations to try to determine the cause for a decline in cognitive functioning,” says Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “Until now, the brain content of β-amyloid neuritic plaques could only be determined with a brain biopsy or examination of the brain at autopsy. This imaging agent is one tool to help physicians in the assessment of their patients by serving as an adjunct to other diagnostic evaluations.”

Following intravenous injection, Amyvid (a radioactive drug) binds to brain β-amyloid. A radioactive signal is detected with a PET scanner to produce images of the plaque in the brain. A positive Amyvid scan indicates moderate to frequent plaques. However, a positive Amyvid scan does not establish a diagnosis of AD because, although patients with AD always have an increased brain content of plaque, the test also may be positive in patients with other types of neurologic conditions, as well as in older people with normal cognition.

source: FDA


Obese Patients Face Higher Radiation Exposure From CT Scans—But New Technology Can Help

Most medical imaging equipment is not designed with overweight and obese patients in mind. As a result, these individuals can be exposed to higher levels of radiation during routine X-ray and CT scans.

A new study from Rensselaer Polytechnic Institute is the first to calculate exactly how much additional radiation obese patients receive from a CT scan. Research results show the internal organs of obese men receive 62 percent more radiation during a CT scan than those of normal weight men. For obese women, it was an increase of 59 percent.

New technology developed at Rensselaer by nuclear engineering expert X. George Xu could help solve this problem. Xu’s research team created ultra-realistic 3-D computer models of overweight and obese men and women, and used computer simulations to determine how X-rays interact with the different body types. These models, known as “phantoms,” can help empower physicians to configure and optimize CT scanning devices in such a way that minimizes how much radiation a patient receives.

“Radiation exposure is cumulative over a patient’s lifetime. The risk associated with a radiation dose from a single CT scan is relatively small when compared with the clinical benefit of the procedure. But patients are increasingly undergoing multiple CT scans and other radiation-based procedures, which can lead to unnecessary radiation risk. Regretfully, our study shows that obese and overweight patients can be exposed to an even greater level of radiation,” said Xu, head of the Nuclear Engineering Program and a professor in the Department of Mechanical, Aerospace, and Nuclear Engineering (MANE) at Rensselaer.

source: Rensselaer Polytechnic Institute