Circa Scientific announced that it completed the limited market release for its CrossWise RF transseptal access system.
Englewood, Colorado-based Circa designed its zero-exchange RF system to deliver energy through a purpose-built cannula. The cannula maintains shape and stability during septal crossing. This approach allows for deliberate control and precise positioning to reduce the risk of unintended movement, even in challenging anatomies.
Bench-top validation demonstrated clean, controlled punctures through a variety of septal conditions. Those included thickened and fibrotic tissue, with successful crossing achieved in as little as 290 milliseconds. Its zero-exchange design eliminates the need for wire or sheath exchanges to support procedural efficiency while maintaining cannula positioning at the septum.
CrossWise features sheath flexibility and a streamlined workflow to meet the needs of physicians across a wide range of cases. It won FDA clearance in September 2024 and Circa reported the first commercial cases with it in January.
Following the limited launch, Circa plans to scale CrossWise commercially across the U.S. in the coming months.
“The completion of our limited market release validates the performance and procedural versatility of the CrossWise system,” said Lee Geist, CEO of Circa Scientific. “Physicians consistently tell us the cannula-first design delivers a greater sense of control and precision at the septum. With broader sheath compatibility, CrossWise is now positioned to support virtually all procedures that require access to the left side of the heart.”
