March 5, 2012

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Article

Utah Company Receives FDA Clearance

Press Release

March 5, 2012

Control Medical Technology announced receipt of United States Food and Drug Administration (FDA) clearance to market the ASPIRE MAX Aspiration System.      

The patented ASPIRE MAX Aspiration System bridges the gap between basic syringe-catheter kits and complex electromechanical systems to remove blood clots, or thrombus, from vessels in the body.  

The core ASPIRE Aspirator is a high-performance aspirator with integrated handles and valves that allows clinicians to instantly create, increase, decrease, slow, stop, or “pulse” aspiration force. MAX Aspiration Catheters are proprietary large internal diameter aspiration catheters available in multiple outer diameters and lengths to improve aspiration speed, force, and control.

Blood clot size, anatomical location, and age can affect procedural success. Aspirating blood clots 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.   

Basic syringe-catheters kits are effective with some thrombus, but lack power, anti-reinjection safety features, and do not give the physician the ability to instantly increase, decrease, pulse, or control aspiration force. Electromechanical systems can be powerful, but lack simplicity, global availability, and may be cost-inefficient.

“We are pleased to receive FDA clearance,” said Shawn Fojtik, CEO of Control Medical and core patent contributor. “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.”

The FDA clearance allows Control Medical to market the ASPIRE MAX 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 (blood clots), and emboli, from vessels in the peripheral vasculature.

“Blood clots vary from acute, fresh, and soft thrombus to chronic, old, and organized 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.”

Control Medical Technology (www.ASPIRATIONMEDICAL.com) is headquartered in Park City, Utah. The patented ASPIRE MAX Aspiration System made in the United States.
(3.5.12)   

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