Spirair announced today that the FDA granted 510(k) clearance for its TurbAlign bioabsorbable implant device.
The company designed the novel, bioabsorbable device to aid healing from sinus surgery. It separates the middle turbinate from the lateral nasal wall during the critical healing period post-surgery.
South San Francisco-based Spirair designed it for insertion by a physician with a simple, one-pass, knot-free technique. The implant provides secure middle turbinate medialization, then resorbs without the need for removal.
“After routine sinus surgery, scarring inside the nose or shifting of important tissues like the middle turbinates—structures that help regulate airflow—can affect healing and overall success,” said Dr. Jayakar Nayak, associate professor of Otolaryngology at Stanford Medicine. “TurbAlign is an innovative, sturdy yet resorbable implant that helps secure these tissues to prevent unwanted adhesions, while preserving open sinus passages.”
Spirair said it expects commercial availability for TurbAlign in the U.S. later this year.
“Our expanding portfolio highlights our commitment to ENT solutions that enhance patient care,” said Ben Bishop, CEO of Spirair. “TurbAlign provides a novel approach to middle turbinate medialization, while SeptAlign targets septal deviation. Together, they provide complementary advancements in nasal and sinus surgery.”
SeptAlign, the company’s system that treats nasal septal deviation, won FDA clearance last year.
