BURL Concepts Inc. announces the first human uses of its FOQUS ultrasound system—powered by SONAS— for brain emboli detection in the Netherlands and United Kingdom.

Using standard bubble test techniques, saline and oxygen microbubbles were administered through venous injection while FOQUS monitored the patient’s entire brain for the appearance of a “curtain” of microbubbles. The presence of these microbubbles enables physicians to identify an existing patent foramen ovale (PFO)—a hole between the heart’s left and right atria that failed to close after birth. Approximately 40% to 50% of patients with cryptogenic stroke have a PFO.  

The FOQUS test is fully automated and can be completed in 40 seconds without sedation. Thus, the test can be performed by a single nurse and does not require the presence of a cardiologist or anesthesiologist, allowing rapid PFO testing to be performed anywhere, including physician offices or diagnostic centers.

“FOQUS allows me to rapidly and easily test my patients for the presence of bubble emboli as part of a PFO evaluation,” said Dr. Martin Swaans, a cardiologist from St. Antonius Ziekenhuis in Nieuwegein. “By simplifying and accelerating testing, we can identify appropriate candidates for PFO closure more efficiently and reduce the risk of recurrent strokes in cryptogenic stroke patients. After completing a series of successful transcranial tests, we will accelerate the use of this new test on our large group of PFO and cryptogenic stroke patients in the upcoming weeks.”

In addition to the Netherlands study, FOQUS has successfully detected PFOs in U.K. patients.

“The successful completion of a series of this new rapid automated non-invasive transcranial test will allow implementation of PFO testing at multiple locations before patients come to Liverpool for a PFO closure procedure,” stated Dr. Nick Palmer, a consultant cardiologist at The Liverpool Heart and Chest Hospital (United Kingdom). “Since the test can be performed by a nurse using standard bubble test techniques, I believe FOQUS will allow us to speed up testing and reduce local waiting lists.”

Powered by SONAS technology, the FOQUS ultrasound system includes a transcranial headset system. The system introduces a new method to assist physicians in diagnosing a PFO, addressing the need for diagnostic tools that are both faster, cheaper, and more readily accessible.

“Just as cardiac arrhythmia testing shifted from hospitals to outpatient settings, FOQUS has the potential to significantly expand access to PFO testing. By enabling rapid, automated testing at the point of care, FOQUS allows physicians to efficiently evaluate more patients and identify individuals earlier who may benefit from a PFO closure device,” BURL Concepts CEO Peter van der Sluis commented. “We’re encouraged by the clinical experience and feedback from cardiologists and look forward to launching FOQUS in the US and Europe later this year.”

BURL Concepts Inc. is a privately-held medical technology company developing and commercializing rapid and inexpensive brain perfusion assessment solutions (FOQUS) to help physicians diagnose a patent foramen ovale. Through its SONAS technology system, clinicians in hospitals and non-hospital settings can non-invasively evaluate cerebral blood flow and accurately guide treatments for patients.