Q’Apel Medical today announced that its Armadillo radial access system won FDA 510(k) clearance.
Fremont, Calif.-based Q’Apel Medical designed the Armadillo to help physicians move from femoral artery access to radial artery access. The company’s radial platform of access catheters is specifically designed to address challenges associated with radial access.
“With the launch of Armadillo, we find ourselves at the forefront of technological innovations that can bring a paradigm shift in the neurovascular industry. At Q’Apel, everything comes back to the clinicians we serve. From our earliest beginnings, we have built tools not merely out of curiosity but out of demand. We have seen and heard the shortcomings doctors face with other products out there—and we are exceptionally focused on creating solutions that work,” CEO King Nelson said in a news release.
The Armadillo platform gives physicians stable access with fewer catheters with a lower profile than typical 8 Fr tri-axial setups, according to the company.
“More neurointerventionalists are converting to TRA due to the safety profile of this type of access and patient satisfaction,” Pascal Jabbour, professor of neurological surgery at Thomas Jefferson University Hospital in Philadelphia, said.