The FDA has cleared the Selution SLR drug-eluting balloon for treating coronary in-stent restenosis, Cordis announced Monday. The device is now the only sirolimus-based drug-eluting balloon available in the US for this indication, according to the company.
In-stent restenosis occurs when scar tissue grows inside a previously placed stent, narrowing the artery again. The Selution SLR balloon is designed to deliver a sustained release of sirolimus directly to the vessel wall during angioplasty, without adding another permanent metal layer.
The approval gives interventional cardiologists a new option for a challenging clinical problem, though the announcement did not include detailed trial data. The source notes the device's unique position as the sole sirolimus-based DEB in the US market, but does not compare it directly with existing paclitaxel-coated balloons.