Acutus Medical today said it received CE mark approval for its transseptal crossing products.
The device is designed to deliver safe and efficient access to the left atrium of the heart. It includes the company’s AcQCross Qx with either the AcQGuide Mini or steerable AcQGuide Flex introducer sheath.
AcQCross Qx features an integrated needle and dilator that supports the passthrough of a 0.032 in. guidewire to be loaded during left atrial access.
“The AcQCross Transseptal System greatly enhances my procedural efficiency by reducing the number of exchanges,” Jose Osorio of Grandview Medical Center in Birmingham, Ala. said in a news release. “I particularly appreciate the ability to quickly reposition the catheter tip to allow for optimizing the septal crossing location on the fossa, as angle of approach can have an important impact on the speed and quality of ablations and implants.”
Acutus Medical’s system also offers manual and safe crossing with a spring-tension needle and uses RF energy to facilitate septal crossing in patients that have challenging anatomy. It is compatible with Valleylab generators that are present in most labs and operating rooms.
“This is a terrific product line and we are seeing really impressive demo-to-conversion rates across the full spectrum of customer segments,” president and CEO Vince Burgess said. “As we mentioned on our last quarterly update, our US transseptal crossing sales have been growing steadily. Despite the continuing COVID headwinds, we remain encouraged by adoption trends in the US and, with our CE Mark now in hand, we look forward to building sales in additional geographies.”