Sam Brusco, Associate Editor04.08.24
Spirair has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for SeptAlign system for minimally invasive, mechanical correction of nasal septal deviation (NSD).
This news follows FDA clearance of the SeptAlign bioabsorbable implant in August 2023 and is the last step in completing the clearance process for the SeptAlign system.
Treatment options for symptomatic NSD have been limited to either over-the-counter medications to alleviate symptoms or invasive surgical techniques like traditional septoplasty to address structural issues causingthese symptoms. Traditional septoplasty can require significant time away from work.
SeptAlign, according to Spirair, can be performed in any service site as part of standard septoplasty techniques. These include the operating room and/or the ambulatory surgical center (ASC).
The bioabsorbable SeptAlign 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. No cartilage is removed, so ENTs can expand therapeutic offerings without limiting future treatment options.
SeptAlign is now being investigated as part of two IRB-approved nonsignificant risk (NSR) U.S. clinical trials. Following the clearance of the SeptAlign system, Spirair said it plans to begin a Series B fundraising round and start commercialization.
“Demand for minimally invasive treatment options has been steadily rising across healthcare in recent years, but there have been few such options for people suffering from symptomatic NSD,” said Benjamin Bishop, CEO of Spirair—Bishop took the corner office last month. “SeptAlign is a minimally invasive treatment that can be safely and conveniently performed under local anesthesia and enables ENTs to expand their treatment options for more patients.”
This news follows FDA clearance of the SeptAlign bioabsorbable implant in August 2023 and is the last step in completing the clearance process for the SeptAlign system.
Treatment options for symptomatic NSD have been limited to either over-the-counter medications to alleviate symptoms or invasive surgical techniques like traditional septoplasty to address structural issues causingthese symptoms. Traditional septoplasty can require significant time away from work.
SeptAlign, according to Spirair, can be performed in any service site as part of standard septoplasty techniques. These include the operating room and/or the ambulatory surgical center (ASC).
The bioabsorbable SeptAlign 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. No cartilage is removed, so ENTs can expand therapeutic offerings without limiting future treatment options.
SeptAlign is now being investigated as part of two IRB-approved nonsignificant risk (NSR) U.S. clinical trials. Following the clearance of the SeptAlign system, Spirair said it plans to begin a Series B fundraising round and start commercialization.
“Demand for minimally invasive treatment options has been steadily rising across healthcare in recent years, but there have been few such options for people suffering from symptomatic NSD,” said Benjamin Bishop, CEO of Spirair—Bishop took the corner office last month. “SeptAlign is a minimally invasive treatment that can be safely and conveniently performed under local anesthesia and enables ENTs to expand their treatment options for more patients.”