Insightra Medical announced 510(k) clearance of their full range of 7Fr IAB catheters and immediate release in the United States.
Irvine, CA (PRWEB) January 19, 2009 -- Insightra Medical Inc., a privately held medical device company based in Irvine, California, markets the most complete range of 7Fr IAB catheters in sizes including: 40cc, 35cc, 30cc, 25cc and 20cc, all in a true 7Fr diameter.
"We want to offer customers product flexibility and a very high level of quality," says Brad Sharp, CEO of Insightra. "The market seems to agree that 7Fr is a big improvement in terms of distal flow, comfort and safety. The key is to deliver that 7Fr benefit to the entire population, and not just those who fit the most popular sizes. That is why we have brought such a complete offering to market."
The balloon catheter already has CE mark approval and is selling globally; the addition of FDA clearance allows Insightra to bring the benefits of this offering to the United States, the largest market for IAB catheters.
The patented 7Fr catheter design is the largest range of that size which utilizes a standard fluid filled core, a proven technology in IAB pumping. This key feature means the catheters can be used on virtually any older model of balloon pump, while being fully compatible with the latest balloon pumps on the market (1). By being broadly compatible, hospitals are not required to upgrade their older machines to newer fiber-optic consoles; a huge cost saving.
The balloon at the heart of the kit has been used in Japan for over 8 years on a wide variety of machines and has clinically demonstrated to perform as well as an 8Fr balloon, even with difficult tachycardia patients. The balloon, which was one of the first to be
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