OSF radiologist excited to have new FDA-approved tool to treat pulmonary embolism

AlphaVac

OSF HealthCare patients enrolled in a clinical trial at OSF HealthCare Saint Francis Medical Center in Peoria, Illinois contributed to the recent FDA approval of a medical device to treat patients who develop a pulmonary embolism (PE). A pulmonary embolism is a life-threatening blockage in pulmonary arteries – a condition that device manufacturer AngioDynamics says affects nearly 900,000 people in the United States every year and is this third leading cause of cardiovascular deaths.

Prompt treatment greatly reduces the risk of death. OSF Saint Francis was one of 25 hospital-based sites across the country to assess the AlphaVac F18⁸⁵ System for the treatment of PE. Patients who enrolled were those with confirmed acute PE with intermediate risk. Patients with more severe risk are often given the clot-busting drug known as TPA and those with the least risk can receive medication to dissolve the clot without requiring a hospital stay.

Daniel Gans, MD, a vascular and interventional radiologist was the lead investigator for the clinical trial that included six OSF Saint Francis patients among the 122 nationwide who qualified. The device was previously approved for use in the treatment of blood clots and blockages in other parts of the body. The new approval expands the device’s use in the non-surgical removal of clots in the lung.

The study results will be released in May but lead researchers say the results showed the device was effective in safely removing blood clots in the patients’ lungs and increasing right ventricle function in PE patients who did well 48 hours after the procedure. Patients were also followed for a month.

Dr. Gans was impressed with the ergonomic handle that he says is an improvement over another similar device that uses mechanical aspiration. The AlphaVac F18⁸⁵ System is a small, flexible aspirational catheter which can basically vacuum the clot out of the blood vessel. Dr. Gans says because of the design, it’s easier to get to the clot quickly, particularly large central clots, and to have confidence the blockage has been properly dislodged and removed.

With future studies that compare the approach to other interventions for PE patients regardless of risk, Dr. Gans thinks the AlphaVac F18⁸⁵ system could prove more effective than using clot busting medication.

“I think as time goes on, we’re probably going to find out that it is very effective and may even become the mainstay of therapy for PE,” Dr. Gans suggests. “The FDA clearance is a major milestone in showing this is a safe and effective option for improving patient outcomes and reducing stress on the heart associated with pulmonary embolism.”