Agitated Solutions announced that it received CE mark approval for its novel Orbis microbubble generator device.
St. Paul, Minnesota-based Agitated Solutions designed Orbis to streamline agitated saline contrast generation and enhance bubble quality. It helps to deliver consistent, clear and bright ultrasound images and more efficient workflows.
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Initially, the company targets saline contrast echocardiography studies (known as “bubble studies”) as the market for Orbis. The studies currently serve as the standard of care for diagnosing right-to-left cardiac shunts, which cause improper blood flow. These can also be a leading cause of stroke, particularly in young people.
According to a news release, approximately a quarter of the adult population has right-to-left shunts. Millions of bubble studies take place globally each year. In these studies, investigators manually mix saline with air to produce microbubbles for implantation. Manual production means bubble consistency can vary, impacting diagnosis. The studies also require one clinician to agitate and inject the saline while a second captures the images, making them resource-intensive and time-consuming.
Orbis products controlled microbubble sizes and concentrations. It can help to improve image quality and facilitate diagnosis of right-to-left cardiac shunts. The technology also requires just one sonographer to administer bubbles as well.
Agitated Solutions currently has a U.S. study underway to support a future FDA submission. It also offers the Orbis device in Canada.
Morgan Evans, co-founder and CEO of Agitated Solutions, said:
“The CE Mark approval underscores the strength of our innovation and its potential to redefine the standard for saline microbubble contrast. We are excited to bring this solution to European clinicians, helping to improve consistency, streamlining procedures, and enhancing diagnostic confidence.”
Dr. Micah Eimber, chief medical officer of Agitated Solutions, said:
“Bubble studies have been conducted with manual agitation for around 60 years. The lack of consistency impacts the ability to accurately diagnose and treat patients. The Orbis™ Microbubble Generator is a major advancement towards providing clinicians a more consistent contrast and image quality, and facilitating downstream care.”
