Vascular intervention + drug-eluting balloon + huge market

The Luminor Drug-Coated Balloon (DCB), developed by iVascular, utilizes patented TransferTech™ nanocoating technology and is a next-generation peripheral vascular interventional device.

In terms of its technical principle, Luminor uses paclitaxel as an anti-proliferative drug at a dose of 3 μg/mm². Paclitaxel is highly lipophilic, allowing for rapid uptake by the arterial wall and irreversible inhibition of smooth muscle cell proliferation through binding to tubulin. The device employs a unique amphiphilic excipient—a water-reduced ester—which combines lipophilic and hydrophilic properties, effectively retaining the drug on the balloon surface while promoting paclitaxel translocation to the vessel wall during dilation.

The coating process employs ultrasonic pulsed spray nanotechnology to break down the microcrystalline paclitaxel and excipient mixture into uniform nanodroplets, forming an ultrathin, multi-layered, independent coating structure. This nanoscale multi-layered design gives the coating flexibility, allowing it to adapt to deformation during balloon folding and dilation, reducing coating cracking. A unique dry-stripping technology promotes the formation of paclitaxel microcrystals, facilitating tissue absorption and long-term retention.

In terms of structural design, Luminor is a dual-lumen catheter system, offering three guidewire compatibility sizes: 0.014″, 0.018″, and 0.035″, to accommodate different vessel sizes. The catheter features a dual-lumen structure from the connector to the tip: a larger, round lumen for guidewire passage and a smaller, elliptical lumen for contrast agent flow to inflate the balloon. Both ends of the balloon are marked with platinum-iridium alloy (Pt/Ir) radiopaque markers for intraoperative positioning; the distal end features a soft polymer round tip to avoid vessel damage; and the catheter shaft is coated with a patented hydrophilic coating to reduce frictional resistance. Preclinical studies show that Luminor controls drug loss during delivery to less than 10%, significantly better than traditional coating technologies. During balloon inflation, the drug is rapidly released within a short inflation time of 30-60 seconds, ensuring sufficient paclitaxel deposition on the target lesion vessel wall.