May 6, 2020
FDA Clears Control Medical's Aspire Max 7–11F Mechanical Thrombectomy Platform
May 6, 2020—Control Medical Technology announced the FDA clearance for the company's Aspire Max 7–11 F mechanical thrombectomy platform to remove blood clots from peripheral vessels.
According to the company, the new device includes 7- (0.090-inch) to 11-F (0.140-inch) outer diameter catheters with flexible dilators for improved tracking. Catheters may be connected to the Aspire aspirator and/or an electromechanical pump for increased speed, force, volume, and control.
Control Medical’s platform also includes the Aspire Max 5–6 F mechanical thrombectomy system with over-the-wire catheters for peripheral vasculature and the Aspire RX-LP mechanical thrombectomy system with rapid exchange catheters for peripheral and coronary vasculature.
“This FDA clearance quadruples our product offering and improves our ability to help patients,” commented Control Medical’s President Shawn Fojtik, in the announcement. “The Aspire Max 7–11F mechanical thrombectomy System includes 20 new large-lumen, flexible, and kink-resistant catheters with dilators powered by the Aspire aspirator and/or an electromechanical pump.” Mr. Fojtik continued, “Blood clots range from soft-fresh clots to hard-aged thrombus. Clinicians need more cost-effective tools to remove blood clots. We plan to introduce more catheter and electromechanical pump innovations for use in peripheral, coronary, and neurovascular procedures.”