23 Aug Capture Vascular, Inc. Secures Updated FDA 510(k) Clearance
Capture Vascular announced today that it has received updated FDA 510(k) clearance that expands the device description for its proprietary MegaVacTM Mechanical Thrombectomy System.
“In working through recent clinical experiences, we continually received feedback from physicians that they wanted to use Capture’s system as a proximal occlusion conduit for atherectomy systems, CTO crossing wires, balloons and stents,” says Eric Wells, CEO of Capture Vascular. “I’m particularly excited that the team was able to meet our customers needs and execute these device advances,” says Wells.
The expanded device description builds off of Capture’s mechanical thrombectomy technology with key features such as centering and securing the occlusion funnel tip position within the vessel and being able to pass other lesion disruptive devices through its lumen. With these updates, Capture’s MegaVacTM Mechanical Thrombectomy System can now provide proximal occlusion, a static work environment, and the removal of emboli and thrombi for even more situations.
“We are confident that Vascular Surgeons, Interventional Cardiologists and Interventional Radiologists will find the system effective and easy-to-use in providing proximal occlusion of antegrade blood flow, thereby reducing the potential for an embolic occurrence while performing highly disruptive peripheral treatments,” says Wells.
Founded in 2013, Capture’s proprietary technology includes the MegaVacTM Catheter with SafeSealTM Technology and the ThromboWireTM Clot Retractor, which makes up the MegaVacTM Mechanical Thrombectomy System. With a strong portfolio of 30 patents, Capture’s innovative system offers several unique features in one simple, efficient, and effective device. For more information about Capture Vascular and its technology please visit www.capturevascular.com.