The US Food and Drug Administration (FDA) has cleared the Aspire Max thrombus aspiration system (Control Medical Technology).
The Aspire Max thrombus aspiration system bridges the gap between basic syringe-catheter kits and complex electromechanical systems. The core Aspire aspirator contains integrated handles and valves allowing clinicians to instantly create, increase, decrease, slow, stop, or “pulse” aspiration force.
The FDA clearance allows Control Medical to market the ASPIRE MAX Thrombus Aspiration Catheter System including an ASPIRE Aspirator and a MAX Catheter as a package and/or MAX Aspiration Catheters alone in multiple sizes with an indication to remove soft fresh thrombi, and emboli, from vessels in the peripheral vasculature.
Blood clot size, anatomical location, and age can affect procedural success. Aspirating thrombus can reduce pain, promote healing, prevent amputation, prevent further organ damage, and save lives. Medical devices used to remove thrombus range from basic syringe-catheter kits to complex electromechanical catheter systems.
“We are pleased to receive FDA clearance,” said Shawn Fojtik, CEO, Control Medical. “Clinicians describe the Aspire as an ‘Aspiration Gas Pedal’ that allows them to control aspiration like never before. We look forward to seeing it used to improve patient care.”
“Blood clots vary from acute, fresh, and soft thrombus to chronic, old, and organised clots,” continued Fojtik. “There is no ‘one size fits all’ technology to remove thrombus. Too often, medical device innovation results in complicated and expensive devices. We want to innovate simple, safe, and high-performance technologies that work better than basic technologies but are easier to use and cost less than complicated alternatives.”