The new Aspire MAX 7 – 11F Mechanical Thrombectomy platform has been designed to remove blood clots from the peripheral vessels

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FDA approves new Mechanical Thrombectomy Platform. (Credit: Pixabay/Reaper DZ)

US-based medical devices technology firm Control Medical Technology has obtained the US Food and Drug Administration (FDA) approval for its Aspire MAX 7 – 11F Mechanical Thrombectomy platform.

The company said that its new Aspire MAX 7 – 11F Mechanical Thrombectomy platform has been designed to remove blood clots from the peripheral vessels.

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

“The Aspire MAX 7 – 11F Mechanical Thrombectomy System includes (20) new large-lumen, flexible, and kink-resistant catheters w/dilators powered by the Aspire Aspirator and/or an electromechanical pump.”

New Thrombectomy platform features catheters with flexible dilators for improved tracking

Thrombectomy is a common procedure conducted for removal of blood clots. Coronary thrombectomy is associated with acute myocardial infarction (AMI), while neurovascular thrombectomy is associated with acute ischemic stroke.

In addition, peripheral thrombectomy is associated with peripheral arterial disease (PAD), acute limb ischemia (ALI), critical limb ischemia (CLI), chronic total occlusion (CTO), deep vein thrombosis (DVT), pulmonary embolism (PE), and other peripheral vascular disease (PVD).

According to the company, clinicians usually access the femoral artery or vein, track a catheter over a guidewire to the thrombus, and apply low-performance suction with an electromechanical pump during a procedure.

The new Aspire MAX 7 – 11F Mechanical Thrombectomy System features 7F (0.090″) outer diameter (OD) to 11F (0.140″) OD catheters with flexible dilators for improved tracking.

The catheters can be connected to the Aspire Aspirator and an electromechanical pump to achieve increased speed, force, volume, and control.

The new platform also includes Aspire MAX 5 – 6F Mechanical Thrombectomy System with over-the-wire catheters for peripheral vasculature, and Aspire RX-LP Mechanical Thrombectomy System with rapid exchange catheters for peripheral and coronary vasculature.

Fojtik added: “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.”