Intracoronary Artery Gene Transfer Using the REMEDY Catheter: Case Studies in Pigs and Humans

Background: Various approaches for the prevention of restenosis after balloon angioplasty have been proposed. Local gene transfer is one of the most anticipated procedures. We used the channel balloon, REMEDY™ as a local gene delivery balloon applying for clinical use. Methods: First, we administered an FITC labeled cis-element 'decoy' to porcine coronary arteries using the REMEDY after balloon inflation. We examined the balloon delivery and gene transduction performance under various situations. Next, we administered an NF_κ B decoy to human coronary arteries using the catheter after stent implantation. Results: We detected fluorescence in the vessel wall with or without denudation before decoy administration and certified crossability in the porcine coronary arteries. In two clinical cases after stent implantation, major complications including dissection and thrombus occlusion, did not occur and the procedure was uneventful. Conclusion: The REMEDY channel balloon is a safe and useful device for delivering genes to coronary arteries, and enables efficient vascular gene transfer.