Agitated Solutions, Incorporated (ASI) announced today that it has been issued a Medical Device Establishment License (MDEL) from Health Canada for its Orbis Microbubble Generator that streamlines the process of saline agitation and delivery for cardiac bubble studies. Orbis is the first tool to automatically agitate the saline with uniform, small bubbles that endure longer for visibility. Orbis is designed to help save time and resources by requiring only a single operator, allowing ease of delivery and producing clear, reliable diagnostic images.
During a standard echocardiogram, a sterile saline solution is manually mixed with air to produce tiny bubbles that are injected into the patient. The bubbles travel to the right side of the heart where they can be viewed to provide information about blood flow through the heart. The bubbles can detect conditions such as patent foramen ovales (PFO) – holes in the heart that did not properly close after birth. Roughly 25-30% of adults have PFOs, often undiagnosed, and in rare cases these PFOs can allow blot clots to travel to the brain and cause a stroke. The standard of care for cardiac bubble studies requires one clinician to conduct the imaging while a second clinician agitates and injects the saline. The process is inefficient and generates inconsistent bubble sizes, volume and longevity. This can subsequently impact timely and consistent patient diagnosis.
Immediately following receipt of the Health Canada license, the first clinical use of Orbis was conducted at University Health Network (UHN) Toronto General Hospital in Toronto, Canada. UHN Toronto General is ranked as the third-best hospital in the world by Newsweek.
