FDA OKs Spirair’s TurbAlign Resorbable Sinus Surgery Implant

Spirair has been granted U.S. Food and Drug Administration (FDA) 510(k) clearance for TurbAlign, a bioabsorbable implant to aid healing from sinus surgery.

The device separates the middle turbinate from the lateral nasal wall during the critical healing period. TurbAlign is implanted with a simple, one-pass, knot-free technique. The implant provides secure middle turbinate medialization, then resorbs without needing removal.

Jayakar Nayak, MD, Ph.D., Associate Professor of Otolaryngology at Stanford Medicine said after routine sinus surgery, scarring in the nose or shifting of the middle turbinates can affect healing and overall success.

“TurbAlign is an innovative, sturdy yet resorbable implant that helps secure these tissues to prevent unwanted adhesions, while preserving open sinus passages,” Dr. Nayak told the press.

The implant’s commercial availability is expected 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.”

The company’s bioabsorbable SeptAlign implant for minimally invasive, mechanical correction of nasal septal deviation received FDA clearance in April 2024. The implant is placed in the cartilage near the front of the nose and holds the straightened septum under tension. The implant dissolves within six months.