FDA clears Insightra IAB catheters

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Insightra Medical, a medical device company, can now market a range of sizes for 7Fr intra-aortic balloon (IAB) catheters after receiving FDA 501(k) clearance. The company said its balloon catheter already has CE mark approval.

The sizes include: 40cc, 35cc, 30cc, 25cc and 20cc—all in 7Fr diameter.

The Irvine, Calif.-based company said that its patented 7Fr catheter design utilizes a standard fluid filled core, a technology in IAB pumping. The feature means the catheters can be used on any older balloon pump model.

The IAB has been used in Japan for more than eight years and has performed as well as an 8Fr balloon, even with tachycardia patients, according to the company. The catheter was designed from the ground up to be 7Fr, not an adaption of an 8Fr technology. The shaft of the catheter is thin, and provides a central lumen, comparable to most 8Fr catheters. This translates to superior gas shuttling plus an 0.028-inch central fluid lumen, which allows for pressure monitoring and the use of a larger 0.025-inch guidewire.