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Competition and Competitive Advantages

 

The Competition

  • Drug-eluting balloons (DEBs; Lutonix/Bard) have entered the market recently and upon expansion deliver the anti-proliferative cytotoxic agent, paclitaxel.

  • Sirolimus and paclitaxel-coated drug-eluting ePTFE grafts are also purported to be in development, but have not entered clinical trials to date.

  • DEBs and grafts rely on the critical assumption that short-term drug delivery will produce long-term benefits; for ePTFE access grafts the key benefit will be measured as a significant improvement in 12 month patency rates.

  • When DEBs are used to expand blood conduits they deliver drug concurrently but so transiently that long-term drug benefits are likely to be minimal.

 

The Cylerus Approach

  • The Cylerus’ approach is based on continuous and prolonged drug delivery directly through the wall of porous ePTFE grafts to maintain concentrated, uniform drug levels at sites of neointimal hyperplasia.