Ovalum Ltd. releases the TraVerse™ micro-catheter for marketing in the U.S.
Following approval in Europe, the TraVerse™ micro-catheter will be marketed separately from the CiTop™ guidewire system previously approved for sale in the European Economic Community and cleared for sale in the U.S. by FDA.
The TraVerse micro-catheter is a unique stainless steel helically laser cut support and exchange catheter used to aid guidewire manipulation in complex angiographic procedures. In addition, it can be used for injection of contrast media for visualization of target lesions.
Noam Shamay, founder and Ovalum Ltd. Chief executive officer, said, “The unique benefit of the TraVerse micro-catheter is the physician’s ability to shape its tip to facilitate complex navigation of wires. An additional benefit of the TraVerse micro-catheter is its extraordinary pushability in comparison to polymeric catheters currently on the market; this can be helpful in situations like failed crossings of balloon catheters in calcified lesions. This is one of the lowest profile micro-catheters on the market with an outside diameter of 0.025” and inside diameter of 0.019”.
“In addition, we have presented excellent first-in-man clinical results of the ExPander™ coronary guidewire at the 2008 CRF – CTO Summit in New York and we expect to gain regulatory clearance this year.”
The CiTop™ Guidewire system is a 0.014” high-end guidewire with a dilatable tip specifically designed for CTO recanalization. The system is made of a highly flexible guidewire body and a distal tip consisting of a working element with dilating capabilities to facilitate wire crossover. The CiTop Guidewire is available in both 6gr and 10gr degrees of stiffness, to address the broad range of artery sizes and occlusion hardness present in peripheral artery disease (PAD) patient anatomy.
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