Advanced NanoTherapies’ SirPlux Duo Balloon Gets Breakthrough Device Nod
Advanced NanoTherapies has received the FDA’s Breakthrough Device designation for its SirPlux Duo drug-coated balloon for treatment of coronary artery disease in vessels smaller than 3.0mm.
The device delivers a combination treatment of sirolimus and paclitaxel in a low-dose, long-term release for stent-like expansion and to prevent renarrowing.
The company previously gained breakthrough designations for the same device for use in coronary in-stent restenosis and peripheral below-the-knee lesions.
The FDA’s Breakthrough Devices Program is intended to provide timely access to medical devices by speeding up their development and review while preserving the statutory standards for premarket approval.