News | November 05, 2007

Novel Agent for Echo May Be as Effective as Nuclear Perfusion

November 6, 2007 - Acusphere Inc. announced that Imagify Perfusion Stress Echo, an investigational new drug developed to assess perfusion using ultrasound (or echocardiography) for the detection of coronary heart disease, was shown to be just as good at determining whether or not a patient has disease (accuracy), according to data from two studies released today at the AHA meeting.

The results were derived from Phase 3 RAMP-1 (real time assessment of myocardial perfusion) and RAMP-2 clinical trials of Imagify (Perflubutane Polymer Microspheres for injectable suspension. Imagify is the first echocardiography imaging agent designed and shown in clinical trials to assess blood flow in the heart (perfusion). Myocardial perfusion is a sensitive marker of coronary heart disease (CHD).

Currently, perfusion information is not available using echocardiography (cardiac ultrasound), but must be obtained using a nuclear stress test. Imagify Perfusion Stress Echo would have many potential benefits over nuclear stress testing, said the manufacturer, including quicker results, lower cost and no exposure to radioactivity.

“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 compared to 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,” said Roxy Senior, M.D., Director of Echocardiology in the Department of Cardiology at Northwick Park Hospital and the Imperial College of Medicine, London UK, and the lead investigator in the RAMP -1 and -2 Phase 3 trials.

According to the Phase 3 data presented today at the American Heart Association’s Scientific Sessions, when compared to nuclear stress — the most frequently used imaging procedure for the assessment of coronary heart disease – Imagify Perfusion Stress Echo was shown to be:

* Just as good at determining whether or not a patient has disease (accuracy)
* Superior in ruling out disease in patients with a lower prevalence of disease (specificity)
* Superior in detecting disease in patients with a higher prevalence of disease (sensitivity)

“While the currently available echo technology can detect wall motion abnormalities one of the hallmarks of coronary artery disease, the detection of a patient’s myocardial blood flow would add a critical piece of the diagnostic puzzle when evaluating patients with heart ultrasound for their risk for heart attack. The results of the RAMP trials reported today suggest that Imagify will enable assessment of wall motion and blood flow, which when combined, is a stronger predictor of coronary artery disease than either finding alone,” said Michael Picard, M.D., Director, Clinical Echocardiography at Massachusetts General Hospital Heart Center and clinical monitor for the RAMP-2 trial.

RAMP-1 Results:

• Accuracy: 3 of 3 ultrasound blinded readers were non-inferior (p

• Sensitivity: 1 of 3 ultrasound blinded readers was non-inferior (p=0.002)

• Specificity: 2 of 3 ultrasound blinded readers were superior (p

RAMP-2 Results:

• Accuracy: 3 of 3 ultrasound blinded readers were non-inferior (p

• Sensitivity: 3 of 3 ultrasound blinded readers were superior (p

• Specificity: 1 of 3 ultrasound blinded readers was non-inferior (p=0.013)

For more information:

Related Content

Fujifilm SonoSite Launches New Point-of-Care Ultrasound Educational Resources
News | Ultrasound Imaging | November 01, 2018
Fujifilm SonoSite Inc. announced the launch of its redesigned SonoSite Institute, a comprehensive online educational...
Canon Medical Launches Healthy Sonographer Program
News | Ultrasound Imaging | October 10, 2018
Canon Medical Systems USA Inc. launched an all-new program designed to help reduce the leading causes of pain and...
Fujifilm SonoSite Unveils SonoSite Synchronicity Ultrasound Workflow Solution
Technology | Ultrasound Imaging | October 04, 2018
Fujifilm SonoSite Inc. announced its entry into the medical informatics space with the launch of a robust point-of-care...
GE Healthcare Expands Collaboration With SonoSim for Ultrasound Education
News | Ultrasound Imaging | October 02, 2018
October 2, 2018 — GE Healthcare announced an equity investment in SonoSim, which specializes in...
Clarius Reveals Wireless Cart-Based Ultrasound System at ACEP 2018
News | Ultrasound Imaging | September 28, 2018
Clarius Mobile Health is introducing the Clarius Cart at the American College of Emergency Physicians (ACEP) 2018...
Healcerion Receives FDA Approval for Sonon 300L Handheld Ultrasound Device
Technology | Ultrasound Imaging | July 09, 2018
South Korea-based Healcerion launched the Sonon 300L wireless handheld ultrasound device to the U.S. market following U...
Esaote Change of Ownership Completed
News | Ultrasound Imaging | April 30, 2018
The acquisition of biomedical equipment company Esaote SpA’s share capital was completed on April 19, the company...
Philips Integrates Reacts Tele-Ultrasound Platform on Lumify Portable Systems

Image courtesy of Philips Healthcare

News | Ultrasound Imaging | March 30, 2018
Philips in partnership with Innovative Imaging Technologies (IIT) announced an industry-first integrated tele-...
Toshiba Medical Rolls Out Interactive Learning Tools for Ultrasound and Vascular Training
News | Ultrasound Imaging | December 04, 2017
Toshiba Medical, a Canon Group company, introduced new educational tools and interactive learning resources to help...
Toshiba Medical's Portable Ultrasound Used in Second Pediatric Mission in Tanzania
News | Ultrasound Imaging | October 05, 2017
October 5, 2017 — To provide lifesaving surgical care for sick children in one of the most underserved countries, 13
Overlay Init