Disposable Angiography Injector Cleared by FDA
The PowrSyringe Injector, manufactured by Pinyons Medical Technology for delivery of contrast agents during angiography, received the requisite blessing from the FDA to commence product marketing. Pinyons is developing a PowrSyringe for other applications, such as balloon catheter inflation and biopsy, as described on the Healthcare Sales and Marketing Network.
The device is used to both inject and aspirate fluid during angiography. The disposable, hand held Injector provides both mechanical and ergonomic benefits compared to conventional approaches for fluid delivery and retrieval. The product design entails a hinge with crossing handles attached to the syringe plunger and barrel. When the handle is squeezed, the plunger advances into the barrel.
The device is a cross between electronic power injectors and traditional syringes, as such they incorporate the benefits of each. Benefits of syringes that are incorporated include cost-effectiveness, simplicity of use, and provision of tactile feedback to users. Benefits conferred from electronic power injectors include improved quality of images and faster speed of injection.
At the September 2007 meeting of the New Cardiovascular Horizons Meeting, the device was presented, including a product demonstration. Injection speed is faster than that noted with syringes. Increased injection rate is associated with reduced use of contrast media and improved quality of images.
Reduced use of contrast can minimize the likelihood of contrast-induced nephropathy (CIN), a condition that can lead to acute renal failure. Pinyons Medical Technology plans further studies to determine the incidence of this condition, as well as improvements in imaging gained with the PowrSyringe. Each year, over ten million angiography procedures are completed, all require injection of contrast media.
October 15, 2007 Related topics: Product Approval & Certification, Imaging, Radiology