Sirolimus Coated Catheter Clears Dysfunctional Hemodialysis Shunts

A novel balloon catheter treats stenotic arteriovenous fistula (AVF) or arteriovenous graft (AVG) vascular access anastomosis.

The Concept Medical (Tampa, FL, USA) MagicTouch AVF Sirolimus coated balloon catheter is indicated for use in percutaneous transluminal angioplasty (PTA) of stenotic lesions of dysfunctional native AVF or AVG that are 4-12 mm in diameter and up to 100 mm in length. Features include a design that combines flexibility and strength, for extended reach and resistance to kinking; a tripod reinforced shaft construction that enables more axial strength and higher pushability; a low profile balloon; and perfect tip adherence to the guide wire, which eliminates the fish mouth effect.

Thanks to exclusive Nanolute technology, Sirolimus is converted into sub-micron sized particles inside encapsulated carriers, which are sprayed onto the balloon surface, providing a uniform coating. The result is reduced in-transit loss of the drug, increased bioavailability and biocompatibility, and faster uptake in tissue on delivery. Upon inflation at the target site, the nano-carrier with Sirolimus drug inside gets transferred to the vessel wall. Due to pH variation, the drug carrier mimics body lipids, liberating the sub-micron sized Sirolimus drug particles to penetrate the deepest layer of the vessel.

“Our preliminary data using the Magic Touch Sirolimus coated balloon at the graft-vein junction of blocked AV grafts, and within native AV fistulas, have been promising to date, with an excellent safety profile and patient acceptability,” said consultant vascular and endovascular Surgeon Tjun Yip Tang, MD, of Singapore General Hospital. “Technical and procedural success has been 100%. We have yet to repeat intervention in those who have had MagicTouch AVF elution to their native fistula, but the follow-up is still early, but we are highly encouraged by this initial pilot data.”

An AVF is the most recommended access for kidney disease patients undergoing dialysis, created by connecting a patient's vein and artery to form a long-lasting site through which blood can be removed and returned. Alternatively, in patients who are unsuitable for a fistula, an AVG--a plastic conduit between an artery and a vein--may be used.

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