Bracco Imaging's SonoVue® Approved for Fallopian Tube Assessment

Bracco Imaging's Regulatory Approval for SonoVue®
Bracco Imaging, a global leader in the realm of diagnostic imaging, has recently celebrated a significant milestone with the approval of its ultrasound contrast agent SonoVue® by China's National Medical Products Administration (NMPA). This approval allows SonoVue® to be utilized in hysterosalpingo contrast sonography (HyCoSy), a procedure designed to assess female infertility through non-invasive methods.
Understanding HyCoSy and Its Importance
HyCoSy employs contrast-enhanced ultrasound to effectively identify various factors contributing to female infertility, specifically focusing on the blockage of fallopian tubes and uterine abnormalities. Infertility linked to these conditions affects around 25% to 35% of women experiencing difficulties conceiving. Thus, the capability to conduct such assessments with high accuracy using HyCoSy is invaluable.
Non-Invasive Procedure with Enhanced Diagnostic Accuracy
This regulatory approval signifies a crucial advancement in infertility management. Unlike traditional laparoscopic techniques requiring invasive procedures to assess tubal patency, HyCoSy offers a non-invasive alternative. Furthermore, HyCoSy circumvents radiation exposure, making it a safer option for women, particularly in their reproductive years.
“The integration of SonoVue® in HyCoSy provides health professionals with a tremendous advantage in detecting tubal and uterine issues contributing to infertility,” expressed Alberto Spinazzi, Chief Medical and Regulatory Officer at Bracco Group. This development underscores Bracco's dedication to enhancing healthcare standards and improving overall patient experiences within the realm of contrast-enhanced ultrasound.
Healthcare Innovations in China
Bracco Imaging is committed to aligning its innovations with the healthcare priorities of various regions, including China. Valtero Canepa, Head of APAC at Bracco Imaging, highlighted that this new approval aligns with the Health China 2030 initiative, aiming for earlier detection and broader access to reproductive health services.
Clinical Evidence Supporting HyCoSy
The efficacy of HyCoSy using SonoVue® has been strongly supported by recent systematic reviews and analyses encompassing 24 clinical studies, involving 1,358 women with infertility and 2,661 fallopian tubes. Results highlighted sensitivity, specificity, and accuracy rates of 93%, 90%, and 96% respectively, establishing HyCoSy with SonoVue® as a reliable standard for assessing fallopian tube patency.
Bracco Imaging's long-standing commitment to enhancing clinical practices is further demonstrated by the vast number of approved indications for SonoVue® across multiple countries. This approval not only reinforces its position in the market but also emphasizes the drive to bring forth non-invasive, high-quality diagnostic tools that resonate with contemporary healthcare objectives.
About Bracco Imaging
Bracco Imaging S.p.A., a subsidiary of the Bracco Group, stands as an innovative leader dedicated to delivering comprehensive solutions and products across various diagnostic imaging modalities. With a strong presence in Milan, Italy, Bracco Imaging aims to improve lives through advanced diagnostic imaging technology. Their extensive portfolio covers key imaging modalities including X-ray, MRI, and Nuclear Medicine, positioning them at the forefront of the industry.
Frequently Asked Questions
What is SonoVue® used for?
SonoVue® is an ultrasound contrast agent approved for use in hysterosalpingo contrast sonography (HyCoSy), aiding in the assessment of fallopian tube patency and female infertility.
What does HyCoSy stand for?
HyCoSy stands for hysterosalpingo contrast sonography, a non-invasive procedure that uses ultrasound with contrast agents to evaluate fallopian tube conditions.
How does HyCoSy compare to traditional methods?
HyCoSy is non-invasive and does not expose patients to radiation, in contrast to traditional methods like laparoscopic procedures or X-ray hysterosalpingography, which may involve higher risks and discomfort.
What are the benefits of using SonoVue® in HyCoSy?
Using SonoVue® in HyCoSy allows for high diagnostic accuracy and ensures patient safety by avoiding invasive procedures and radiation exposure during assessments.
How does Bracco Imaging support healthcare advancements?
Bracco Imaging actively aligns its innovations with healthcare priorities, providing reliable and effective diagnostic tools that enhance standards of medical care and meet critical health objectives.
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