When Spirair co-founders Brandon McCutcheon, MD and James Kintzing, PhD, began developing SeptAlign™, they needed to find a material that could hold the nasal septum under tension during cartilage remodeling but also resorb within an appropriate time frame.
They shared how they identified the unmet need for a treatment option like SeptAlign, how they selected the material for SeptAlign, and what’s next for Spirair following SeptAlign’s FDA clearance. Read their contributed article in Medical Design & Outsourcing for more.
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SEPTALIGN™ Indications for Use: SeptAlign™ is a proprietary bioabsorbable implant used to support and straighten minor deviations in septal cartilage when sufficient healthy cartilage exists and the cartilage is appropriately mobilized using standard septoplasty techniques. Potential adverse reactions are those typically associated with surgically implanted materials, including chronic inflammatory foreign body reaction, infection, septal perforation, and extrusion.
TURBALIGN™ Indications for Use: TurbAlign™ is intended to separate the middle turbinate from the lateral nasal wall during the clinically relevant healing phase associated with sinus surgery (e.g., endoscopic sinus surgery, FESS). The implant provides short-term fixation of the middle turbinate to the nasal septum and thus minimizes the risk of adherence to the lateral wall.
References:Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
SPIRAIR®, SEPTALIGN™ and TURBALIGN™ are trademarks of Spirair Inc.
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