The FDA issued approval to FCI Ophthalmics (Pembroke, MA) for the OphtaCath lacrimal duct balloon catheter, a device used to dilate the lacrimal duct for treatment of epiphora, or excessive tears in the eyes.
Available in 2mm or 3mm sizes, and a delivery device that uses one or two balloon catheters, the OphtaCath provides an incisionless and tube-free option for epiphora treatment. The semi-flexible balloon retains its shape memory before and after inflation and the inflation device allows for precise control of pressure delivered to the balloon. The balloon is made of a high strength material that resists bursting even at high pressures.
Product page: OphtaCath — Lacrimal Duct Balloon Catheter…
Press release: FDA Approves OphtaCath Lacrimal Balloon Catheter…