News | June 15, 2010

Contrast Agent Demonstrates Positive Safety Profile

June 15, 2010 – A new study evaluating the safety of an echocardiography contrast agent found that the agent did not have a significant effect on patients’ pulmonary pressures. The findings, concerning the contrast agent Definity Vial For (Perflutren Lipid Microsphere) Injectable Suspension, were presented on June 13 at the American Society of Echocardiography Annual Scientific Sessions in San Diego.

Kevin Wei, M.D., associate professor of medicine at Oregon Health & Science University, presented the data from the phase 4, open-label safety study by Lantheus Medical Imaging Inc. on the effect of Definity on pulmonary and systemic artery hemodynamics in patients with either normal or increased baseline pulmonary artery pressure. The study demonstrated that administration of Definity did not result in any clinically or statistically significant changes in systemic or pulmonary artery hemodynamic measurements in either patient group.

“Examining changes in pulmonary pressures following the administration of ultrasound contrast imaging agents is an important safety measurement,” said Wei. “This phase 4 safety evaluation demonstrated that the administration of Definity produced no changes in pulmonary or systemic hemodynamic parameters, either in patients with normal or increased pulmonary artery pressure at baseline, providing further validation of the safety profile of this agent.”

Definity administration did not result in any clinically or statistically significant changes in systemic and pulmonary artery hemodynamic measurements in the patients with either normal or elevated PASP in the population tested. Overall, Definity demonstrated a positive safety profile and was well tolerated. No deaths, serious adverse events (SAE) or other significant adverse events (AE) occurred during the study. Results of the immunologic tests showed no evidence for hypersensitivity reactions in any patient. Additionally, there were no clinical events that suggested evidence of mast cell activation or hypersensitivity reactions related to Definity administration.

References
1 Kitzman, D.W. et al. “Efficacy and safety of the novel ultrasound contrast agent perflutren (Definity) in patients with suboptimal baseline left ventricular echocardiographic images.” American Journal of Cardiology. 2000; 86: 669-674.
2 Data on file, Lantheus Medical Imaging Inc.
3 Source: The Echocardiography Monthly Monitor: U.S. Editions, 2002 - 2009, Arlington Medical Resources Inc., Malvern, PA.
4 Mulvagh, S.L., et al. “Contrast Echocardiography: Current and future applications.” Journal of the American Society of Echocardiography 2000; 13:331-42.
5 Waggoner A.D., et al. “Guidelines for the cardiac sonographer in the performance of contrast echocardiography.” Journal of the American Society of Echocardiography. 2001: 417-420.
6 Edited by Scott D. Solomon, M.D., "Essential Echocardiography, A Practical Handbook with DVD." Humana Press; 2007 Chapter 5: Ventricular Systolic Function, P113.
7 Shaw L.J., et al. “Clinical and economic outcomes assessment with myocardial contrast echocardiography.” Heart 1999; 82(Suppl III): III16-III21.

Related Content

Philips Lumify Earns U.S. Army Airworthiness Certification
News | Ultrasound Imaging | May 22, 2019
Philips announced that Philips Lumify, a point-of-care ultrasound device, has earned the U.S. Army Airworthiness...
Clarius Releases Clarius Live Ultrasound Telemedicine Solution
Technology | Ultrasound Imaging | May 15, 2019
Clarius Mobile Health released a telemedicine solution called Clarius Live. The simple-to-use feature allows any...
Ultrasonic Device Safe and Effective for Lung Vessel Sealing in Minimally Invasive Lobectomy
News | Interventional Radiology | May 06, 2019
According to a new study, an ultrasonic vessel-sealing device can improve patient outcomes by reducing the incidence of...
Hong Kong Polytechnic University Develops Palm-sized 3-D Scoliosis Ultrasound Imaging System
News | Ultrasound Imaging | May 03, 2019
The Hong Kong Polytechnic University (PolyU) announced the development of a palm-sized 3-D ultrasound imaging system...
New Guideline Published for Evaluation of Valvular Regurgitation After Catheter-based Valve Interventions
News | Cardiovascular Ultrasound | April 30, 2019
A new document compiled by four cardiac imaging professional societies provides a resource to guide clinicians in best...
Six Predictions on How the Ultrasound Systems Market Will Expand Through 2022
News | Ultrasound Imaging | April 26, 2019
With healthcare costs continuing to rise, affordable and accurate imaging and diagnosis achieved through ultrasound...
ITN Wins Jesse H. Neal Award for Best Technical Content
News | Radiology Business | April 24, 2019
April 24, 2019 — Imaging Technology News (ITN) was recently named the 2019 Jesse H.
Ebit and DiA Imaging Analysis Partner on AI-based Cardiac Ultrasound Analysis
News | Cardiovascular Ultrasound | April 16, 2019
DiA Imaging Analysis has partnered with the Italian healthcare IT company Ebit (Esaote Group), to offer DiA’s LVivo...
360 Photos | 360 View Photos | April 12, 2019
This 360 degree view shows staff at the ...
Example of full-dose, 10 percent low-dose and algorithm-enhanced low-dose. Image courtesy of Enhao Gong, Ph.D.

Example of full-dose, 10 percent low-dose and algorithm-enhanced low-dose. Image courtesy of Enhao Gong, Ph.D.

Feature | Contrast Media Injectors | April 11, 2019 | By Jeff Zagoudis
One of the most controversial issues in radiology in recent years has been the use of...