SonoVue approved in China for intravesical use in ultrasonography of the excretory tract to detect vesicoureteral reflux
June 21, 2018 –
Milan (Italy), June 20, 2018 – Bracco Imaging S.p.A., a global leader in diagnostic imaging, recently announced that its ultrasound contrast agent SonoVue® (sulphur hexafluoride microbubbles) has been the first approved in China for use in ultrasonography of the urinary tract (voiding ultrasonography) for the evaluation of suspected or known vesicoureteral reflux (VUR) in pediatric patients.
VUR is a urinary tract abnormality in neonates, infants and children characterized by retrograde flow of urine from the bladder into the ureter and toward the kidney and represents a common cause of recurrent urinary tract infections and chronic nephropathy in pediatric patients. Voiding cysturethrography and direct radionuclide cystography are the imaging procedures currently used to diagnose VUR, and both require exposure to ionizing radiation.
“This approval of SonoVue® for voiding ultrasonography addresses an important unmet medical need for accurate detection and follow-up of VUR, a frequent cause of urinary tract infections and renal complications in neonates, infants and young children, without exposing them to the potential harmful effects of ionizing radiation,” stated Alberto Spinazzi, MD, Head, Global Medical and Regulatory Affairs, Bracco Group.
“We are particularly proud that, after United States and Europe, now this important indication for our contrast ultrasound agent SonoVue® has been also approved in China,” said Fulvio Renoldi Bracco, Chief Executive Officer at Bracco Imaging. “This new indication for SonoVue® reflects our efforts and investments to offer significant clinical benefit by expanding the range of approved clinical indications for contrast enhanced ultrasound in China, one of the most relevant areas of development for Bracco”.
Since 2004, China has been at the forefront of research in contrast enhanced ultrasound, with the development of innovative clinical applications in various clinical scenarios and patient populations. SonoVue® is the ultrasound contrast agent most widely used in clinical studies and routine clinical practice in China, and the first and only approved for use in the pediatric population in this country.