News | July 11, 2012

Study Shows Safety of Ultrasound Contrast Agent

Study evaluated more than 1,000 patients with wide-ranging characteristics, including pre-existing cardiopulmonary conditions and critical illness

Study Shows Safety of Ultrasound Contrast Agent

July 11, 2012 — Lantheus Medical Imaging Inc., a developer, manufacturer and distributor of diagnostic imaging agents, announced the publication of results from the CaRES (Contrast Echocardiography Registry for Safety Surveillance) multicenter safety registry for its ultrasound imaging agent Definity Vial for (Perflutren Lipid Microsphere) Injectable Suspension. The CaRES study found that Definity was well-tolerated in patients of different types undergoing clinically-indicated Definity-enhanced echocardiography in a broad range of typical clinical settings. The results were published in the July 2012 issue of the Journal of the American Society of Echocardiography (Weiss et al, 2012)

The prospective, open-label, nonrandomized registry study was designed to assess the risk of adverse clinical events occurring within 30 minutes of Definity administration in a routine clinical setting. Among the 1,053 patients who completed the study, no deaths, life-threatening events, serious adverse events or serious anaphylactoid (allergic) reactions were reported during or after Definity administration. The overall adverse event (AE) rate was 10.8 percent, and drug-related AE rate was 3.5 percent. Of the AEs that occurred during or after Definity administration, a substantial majority 96.5 percent were mild to moderate in intensity.

The CaRES study complements another recently published study on the hemodynamic effects of Definity in patients with pulmonary hypertension. Published in the May 2012 issue of the Journal of the American Society of Echocardiography (Wei et al, 2012), this prospective study evaluated 32 patients, half of whom had elevated baseline pulmonary artery systolic pressures. The study found that Definity administration did not result in any clinically meaningful changes in systemic and pulmonary artery hemodynamic measurements among patients with either normal or elevated pulmonary artery pressure. In addition, no serious or fatal adverse events occurred. Overall, Definity demonstrated a positive safety profile and was well-tolerated.

Both the CaRES study and the pulmonary hypertension study were developed in conjunction with the U.S. Food and Drug Administration (FDA) in 2008 as part of a risk assessment program for perflutren-based ultrasound contrast agents such as Definity.  In October 2011, the FDA approved several revisions to the Definity prescribing information, including the removal of mandatory physiologic monitoring requirements for patients with pulmonary hypertension or unstable cardiopulmonary conditions.  Data from both the CaRES and pulmonary hypertension studies were included in the updated Definity labeling.

For more information: www.definityimaging.com

Related Content

EchoGo uses artificial intelligence (AI) to calculate cardiac ultrasound left ventricular ejection fraction (EF), the most frequently used measurement of heart function, left ventricular volumes (LV) and, for the first time for an AI application, automated cardiac strain.

EchoGo uses artificial intelligence (AI) to calculate cardiac ultrasound left ventricular ejection fraction (EF), the most frequently used measurement of heart function, left ventricular volumes (LV) and, for the first time for an AI application, automated cardiac strain.

News | Cardiovascular Ultrasound | November 14, 2019
November 14, 2019 — Ultromics has received 510(k) clearance from the U.S.

Guerbet presented its Contrast&Care injection management solution at ECR 2018

News | Contrast Media | November 13, 2019
November 13, 2019 – Guerbet, a global specialist in...
Mindray announced its partnership with Cincinnati Children's Hospital Medical Center, one of the top children's hospitals in the United States
News | Ultrasound Imaging | November 13, 2019
November 13, 2019 – Mindray announced its partnership with...
Using artificial intelligence to predice risk of thyroid cancer on ultrasound.

Using artificial intelligence to predice risk of thyroid cancer on ultrasound.

News | Artificial Intelligence | November 06, 2019
November 6, 2019 — Thyroid nodules are small lumps that form within the thyroid gland and are quite common in the gen
Windsong Radiology Group

Windsong Radiology Group

Sponsored Content | Case Study | Contrast Media Injectors | October 30, 2019
Windsong Radiology Group is a New York-based radiolo
The Konica Minolta Sonimage HS1 hand-carried system is designed for point of care ultrasound (POCUS) use for an immediate, quick look inside the patient. POCUS systems from several vendors are seeing rapid growth.

The Konica Minolta Sonimage HS1 hand-carried system is designed for point of care ultrasound (POCUS) use for an immediate, quick look inside the patient. POCUS systems from several vendors are seeing rapid growth.

Feature | Ultrasound Imaging | October 24, 2019 | Joan Toth
With the miniaturization of technology, improved ease of use, lower system cost, increased portability, and greater
Exact Imaging Receives FDA 510(k) Clearance for Sterile Transperineal Needle Guide
Technology | Ultrasound Imaging | October 24, 2019
Exact Imaging received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Sterile Transperineal Needle...
The Revolution Apex intelligent computed tomography (CT) scanner

The Revolution Apex intelligent computed tomography (CT) scanner. Image courtesy of GE Healthcare.

News | RSNA | October 18, 2019
At the 2019 annual meeting of the Radiological Society of North America (RSNA 2019), Dec. 1-6 in Chicago, GE Healthcare...
Philips Partners With PURE on Tele-Ultrasound Program for Physicians in Rwanda
News | Ultrasound Imaging | October 09, 2019
Philips and non-profit organization PURE (Point-of-care Ultrasound in Resource-limited Environments) highlighted a tele...