The Memo: CygnusMed Building the First Endovascular Access System Allowing for Continuous Blood Pressure Monitoring

Under the direction of Founder and CEO Firas Al-Ali, MD, CygnusMed is developing an endovascular access system designed to create continuous sealing of the guiding catheter, eliminating blood reflux and stagnation into it, a first in endovascular intervention. This significantly reduces embolic risk and blood loss while enabling continuous arterial pressure monitoring during endovascular procedures. Headquartered in Akron, Ohio, the company is advancing its EndoSphinx platform to address long-standing limitations in endovascular technologies, beginning in neuroendovascular care and with a long-term vision to expand across the full spectrum of endovascular procedures worldwide.

Origin Story

CygnusMed was born directly from clinical experience. Al-Ali, a neuro-interventionalist with more than 25 years of practice, repeatedly encountered “limitations in existing endovascular technologies that are often accepted as unavoidable but carry real consequences for patients.”

One particular case profoundly shaped his thinking. “I performed an elective brain aneurysm coiling on a young woman. The procedure itself was technically flawless,” he explained. “Shortly after waking up from anesthesia, however, the patient complained of a mild headache. An MRI revealed a small focal embolic lesion in the region where I had been working.”

The patient exhibited no neurological deficits and was discharged without symptoms, but the finding raised a deeper concern. “This was not a difficult or complicated case, yet an embolic event still occurred. That realization prompted a critical question: if embolization can occur in a perfectly executed procedure, then the problem must be structural, not technical.”

That insight led him to reexamine the fundamentals of endovascular intervention. “I began to analyze the mechanics of endovascular intervention and identified a key issue: current systems allow blood to reflux back into the guiding catheter lumen. This blood stagnates within the catheter, where it can clot. When contrast is subsequently injected, these microthrombi are flushed back into the circulation.”

From this realization, CygnusMed and its foundational technology, EndoSphinx, were created. “I developed a novel valve system designed to continuously seal the system, including time of microcatheter insertion, removal, or manipulation, maintaining constant, stable pressure inside the guiding catheter so blood does not reflux and clot within it, decreasing the risk of embolism. It also significantly reduces current blood loss, an important limitation in all endovascular systems. With a constant pressure inside the system, integrating a pressure sensor in the device allows for constant blood pressure monitoring, eliminating the current need for a second arterial obtained solely for this purpose,” he said.

The Current Landscape

Endovascular procedures are among the most widely performed interventions in modern medicine. Each year, approximately 10 million endovascular procedures are performed in the United States alone, with more than 25 million procedures worldwide. In every one of these interventions, the operator must insert a guiding catheter into the patient’s blood vessel, with the external end connected to a hemostatic valve.

Despite the scale and growth of endovascular care, key clinical, operational, and economic challenges remain largely unaddressed.

“Current systems allow uncontrolled saline flushing while still permitting blood to reflux into the guiding catheter,” Dr. Al-Ali explained. “This blood stagnates and can clot. When contrast is injected, these microthrombi are flushed back into the circulation, effectively causing a shower of emboli to the target organ, whether the brain, heart, kidneys, or peripheral vasculature.”

Blood loss represents another underrecognized issue. “Because catheter sealing is intermittent rather than continuous, blood loss during endovascular procedures is common and often underestimated,” he said. “Up to 4% of patients undergoing endovascular interventions lose as much as 25% of their circulating blood volume, leading to higher mortality, increased complications, and elevated readmission rates.”

This blog is originally published here: https://www.lifesciencemarketresearch.com/insights/the-memo-cygnusmed-building-the-first-endovascular-access-system-allowing-for-continuous-blood-pressure-monitoring

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