NMPA Approves Domestic First Bio-Degradable Nasal Septal Cartilage Fixation System

On May 18, NMPA officially announced the marketing approval for the innovative “Nasal Septal Absorbable Fastener Fixation Device,” independently developed by Hefei Qihao Medical Technology Co., Ltd (Breath Medical). The product marks China’s first domestically approved fully degradable nasal septal cartilage fixation system.

1. Product Composition and Scope of Application

The system consists of a reusable delivery applicator (applicator) and absorbable fasteners (pins). It is clinically indicated for aligning and connecting soft tissues during nasal septal surgeries. According to public disclosures from the NMPA, the device features an easy-to-use clinical deployment mechanism that successfully shortens overall operative time and significantly minimizes trauma to the nasal mucosa.

From a clinical workflow standpoint, securing the nasal septal mucosa, cartilage, and surrounding tissues is a critical steps following a septoplasty or functional endoscopic sinus surgery (FESS). Traditional suture fixation requires complex suturing and knotting within the narrow nasal cavity, demanding high surgical dexterity and prolonged operating times. Breath Medical’s newly approved absorbable system addresses this hurdle by utilizing bio-absorbable pins for tissue approximation and attachment, delivering a far more efficient, instrumented alternative for septal stabilization.

2. Key Technical Innovations

• Absorbable Pin Fixation: During the procedure, the surgeon uses the dedicated delivery applicator to precisely deploy the absorbable pins into the target tissue site for soft tissue approximation. Compared to traditional manual suturing, this automated approach eliminates repetitive stitching and knotting inside the constricted nasal passage.
• Optimized for Microscopic Spaces: The internal anatomy of the nasal cavity is notoriously restrictive, requiring surgical instruments to offer maximum accessibility, stability, and speed. This system standardizes and automates the fixation movement, drastically improving intraoperative efficiency.
• Fully Bio-Degradable Material: The fixation pins are engineered from an advanced bio-absorbable polymer that provides stable structural support during the initial healing phase before gradually degrading and being fully resorbed by the body. This eliminates the post-operative burden of suture removal or permanent foreign-body reactions, improving overall patient recovery.
• Targeted Modernization of Traditional Techniques: Rather than disrupting the overarching sequence of a septoplasty, this device introduces a targeted innovation to the “tissue fixation” phase. It replaces tedious manual hand-sewing with a reliable, clip-like mechanical anchoring solution, allowing clinicians to achieve tissue approximation in seconds.

3. Clinical Efficacy and Market Significance

• Reduced Operative Time: Official NMPA data confirms that the device’s simplified mechanical deployment yields a much faster procedure. For high-frequency ENT operations, speeding up the closure phase optimizes the overall efficiency of the operating room.
• Minimized Mucosal Trauma: The nasal mucosa is highly sensitive and prone to tearing or localized trauma during traditional needle piercing and suture tensioning. The mechanical fixation method provides clean tissue alignment with minimal structural handling, keeping the mucosal lining intact.
• Enhanced Patient Recovery: The system is characterized by minimally invasive convenience, rapid fixation to prevent tissue tearing, and full degradation to reduce post-operative pain.
• Driving Domestic ENT Innovation: The approval of this device as a national innovative medical apparatus signals that domestic Chinese enterprises are actively solving niche pain points in high-volume ENT procedures.