Imagify™- first imaging agent to assess myocardial perfusion using ultrasound
Myocardial perfusion is considered a sensitive marker for the diagnosis of coronary heart disease. Currently, the most frequently used imaging procedure to gain information about the status of myocardial perfusion is a nuclear stress test. This situation is about to change as Imagify (Perflubutane Polymer Microspheres), developed by Acusphere, Inc., could become the first injectable echocardiography imaging agent, this significantly expanding the diagnostic abilities of heart ultrasound.
Current generation ultrasound equipment is used to detect cardiac wall motion abormalities but, until recently, it was not possible to measure the blood flow in the heart muscle. The use of Imagify as an imaging agent enables the physician to visualize the patient’s myocardial blood flow. Being able to assess both wall motion and perfusion in one process is a huge step forward in heart ultrasound diagnostics.
“Imagify is an excellent perfusion imaging agent. It is superior to standard stress echocardiography since it enables perfusion to be assessed in real time, and it is just as accurate as nuclear stress testing,” says Roxy Senior, MD and Director of Echocardiology at the Department of Cardiology at Northwick Park Hospital and the Imperial College of Medicine, London, UK.
Roxy is lead investigator in the RAMP -1 and -2 Phase 3 trials which were presented at the annual American Heart Association meeting in Orlando, Florida, USA. 662 patients participated in the international multi-center trials that were designed to compare the significance of Imagify Perfusion Stress Echo at stress and rest with isotope testing at stress and rest in the three key issues accuracy, sensitivity and specificity. The results clearly indicate that Imagify Perfusion Stress Echo is as effective as isotope testing and a well-tolerated, minimally-invasive approach to evaluate chest pain patients at risk for heart attack. Reported adverse effects were only of mild intensity and transient after a short period of time. “Furthermore, the benefits of this important new approach for patients and physicians are very clear: ultrasound equipment is widely available, faster to use and far less expensive than nuclear stress testing. In addition, since there is no radiation involved, it is safer for the patient and eliminates hazardous waste disposal for the facility,” adds Roxy.
Acusphere, a pharmaceutical company that develops new drugs and improved formulations of existing drugs, is very proud of their innovative product. “More than 16 million people in the United States suffer from coronary heart disease. Imagify is perfectly suited for the diagnosis of these patients as it enables myocardial blood flow assessment in simple stress echo procedures. The compelling data from these Phase 3 trials supports a strong NDA submission early in 2008 to address a very significant need,” concludes Sherri C Oberg, President and CEO of Acusphere.
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