US-based medical equipment supplier Spirair has received the US Food and Drug Administration (FDA) clearance for its TurbAlign implant.
TurbAlign is a bioabsorbable device designed to support the healing after sinus surgery by maintaining open nasal passages.
The implant, which resorbs naturally, eliminates the need for removal, offering a minimally invasive solution for otolaryngologists (ENTs).
TurbAlign is inserted using a simple, one-pass, knot-free technique, providing secure medialisation of the middle turbinate.
The advanced approach ensures the separation of the middle turbinate from the lateral nasal wall during the critical healing period following sinus surgery.
Spirair plans to commercially launch the implant in the US later this year.
Stanford Medicine Otolaryngology associate professor Jayakar Nayak said: “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.
“TurbAlign is an innovative, sturdy yet resorbable implant that helps secure these tissues to prevent unwanted adhesions, while preserving open sinus passages.”
Founded in 2020 by James Kintzing and Brandon McCutcheon, Spirair focuses on developing minimally invasive solutions for ENTs to improve patient outcomes.
The company emerged from the Stanford Biodesign Innovation Fellowship and Fogarty Innovation programmes.
Spirair also offers SeptAlign, another bioabsorbable implant designed to correct nasal septal deviations, approved by the US FDA last year and is available in the US.
SeptAlign supports the nasal septum, dissolving within six months, and can be used in various settings, including offices, operating rooms, and ambulatory surgery centres.
Spirair CEO Ben Bishop said: “Our expanding portfolio highlights our commitment to ENT solutions that enhance patient care.
“TurbAlign provides a novel approach to middle turbinate medialization, while SeptAlign targets septal deviation. Together, they provide complementary advancements in nasal and sinus surgery.”
