Aspiration system using real-time MRI guidance gains FDA clearance

Irvine, California-based MRI Interventions announced that it has received FDA clearance for its ClearPoint PURSUIT Neuro Aspiration system. The solution helps surgeons identify an aspiration target using real-time MRI guidance and monitor aspiration during the procedure. It was developed as part of a collaboration with the Mayo Clinic.

“We are thrilled to bring this exciting new therapy to our customers and to patients,” commented Matt Rabon, portfolio manager for neuro aspiration and MRI at MRI Interventions, said in a prepared statement. “This is the first internally developed therapeutic product in our portfolio and represents further execution of our four-pillar growth strategy. We believe that combining navigation with therapy will yield benefits to physicians by streamlining workflows, reducing procedure time, and documenting success of the procedure in the patient record. Image guided therapy has led the transition from open procedures to more minimally invasive procedures and represents a glimpse into the focus and the future of our company.” 

According to the statement, the PURSUIT system is presently being implemented in the United States as part of a limited market release. A commercial launch is scheduled for the first half of 2019.