Control Medical Technology
(Park City, Utah) announced today that the FDA has cleared its Aspire MAX 7 – 11F mechanical thrombectomy device to remove blood clots from peripheral vessels.
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).
The new Aspire system includes 7F (0.090 in.) outer diameter (OD) to 11F (0.14 in.) OD 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.
During a procedure, clinicians typically access the femoral artery or vein, track a catheter over a guidewire to the thrombus, and then apply low-performance suction with a basic syringe or pulsed continual high-performance vacuum with an Aspire mechanical aspirator or an electromechanical pump, according to the company.
“This FDA clearance quadruples our product offering and improves our ability to help patients,” said Control Medical president Shawn Fojtik in a news release. “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.”
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May 06, 2020 at 10:27PM
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Control Medical wins 510(k) for blood clot removal device - Mass Device
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