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May 7, 2020

US FDA clears Control Medical’s catheter platform

Control Medical Technology has received the US Food and Drug Administration’s (FDA) clearance for its Aspire MAX 7 – 11F Mechanical Thrombectomy platform to remove blood clots from peripheral vessels.

Control Medical Technology has received the US Food and Drug Administration’s (FDA ) clearance for its Aspire MAX 7 – 11F Mechanical Thrombectomy platform to remove blood clots from peripheral vessels.

The new system includes 7F (0.090″) outer diameter (OD) to 11F (0.140″) OD catheters with flexible dilators for improved tracking. For increased speed, force, volume and control, the catheters may be connected to the Aspire Aspirator or an electromechanical pump.

Additionally, new large-lumen, flexible and kink-resistant catheters with dilators powered by the Aspire Aspirator and / or an electromechanical pump are included in the new system.

Thrombectomy, also known as blood clot removal, is a common procedure, according to the company.

Coronary thrombectomy is associated with acute myocardial infarction (AMI), neurovascular thrombectomy with acute ischemic stroke and peripheral thrombectomy is associated with peripheral arterial disease (PAD).

The clinicians usually access the femoral artery or vein and track a catheter over a guidewire to the thrombus during the procedure. Then, they apply low-performance suction with a basic syringe or pulsed continual high-performance vacuum.

Control Medical technology president Shawn Fojtik said: “This FDA clearance quadruples our product offering and improves our ability to help patients.

“Blood clots range from soft-fresh clots to hard-aged thrombus. Clinicians need more cost-effective tools to remove blood clots.”

The new catheter platform also includes the Aspire MAX 5 – 6F 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.

The company expects to launch additional catheter and electromechanical pump innovations for use in peripheral, coronary and neurovascular procedures.

Control Medical Technology designs, develops and commercialises medical devices.

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