References

  1. Crawford-Brown, Theoretical and Mathematical Foundations of Human Health Risk Analysis; 1997, Page 103.
  2. Value calculated based on 2014 US population estimate from US Census and World Bank data in conjunction with incidence numbers cited in Stewart et al. Epidemiology and burden of nasal congestion. Intl J Gen Med 2010; 2010:3 37-45.
  3. Rhee et al. Nasal Valve Surgery Improves Disease-Specific Quality of Life. Laryngoscope 115: March 2005.
  4. Wever, The Nasal Airway: A Critical Review; Facial Plast Surg 2016;32:17–21.
  5. Camacho et al, The Effect of Nasal Surgery on Continuous Positive Airway Pressure Device Use and Therapeutic Treatment Pressures: A Systematic Review and Meta-Analysis; SLEEP, Vol. 38, No. 2, 2015.
  6. Lin et al, Nasal Aerodynamics. May 14, 2015.
  7. Constantian MB, Clardy RB. The Relative Importance of Septal and Nasal Valvular Surgery in Correcting Airway Obstruction in Primary and Secondary Rhinoplasty. Plastic and Reconstructive Surgery. 1996 Jul; 98(1): 47.
  8. Ricci, et al. Role of Nasal Valve in the Surgically Corrected Nasal Respiratory Obstruction: Evaluation Through Rhinomanometry. American Journal of Rhinology. September-October 2001, Vol. 15, Nov. 5.
  9. Nasal Obstruction Symptom Evaluation (NOSE) survey is a quality of life survey supported by the AAO Consensus Statement. Otolaryngology–Head and Neck Surgery: 162 STEWART et al February 2004.
  10. Histologic findings based on implants placed in ovine model (N=6 animals at 6wks, N=2@12mo, N=1@18mo, N=1@24mo).
  11. San Nicolo, et. al. 2017. Absorbable Implant to Treat Nasal Valve Collapse. Facial Plast Surg, 32:233-240.
  12. Data are individual results for a single site in the Spirox study, in 21 patients at 12 months.
  13. Market research is ongoing. Data on file (TR-21076 Spirox NVC Experience). Individual patient results may vary and may include other procedures. Use of the LATERA device in conjunction with other procedures (such as septoplasty and/or turbinate reduction) has not been clinically evaluated. Patient satisfaction results may be attributed to LATERA with other procedures.
  14.  18-24 month data of file. 95% confidence interval indicated.
 
INDICATIONS FOR USE
The LATERA Absorbable Nasal Implant is indicated for supporting upper and lower lateral nasal cartilage. CAUTION: Federal law restricts this device to sale by or on the order of a physician.
 
CONTRAINDICATIONS
  • Presence of an active infection at the implantation site.
  • Patients known or suspected to have an allergy to PLA or absorbable materials.
WARNINGS
  • Intended for single use only. Do NOT re-sterilize and/or reuse.
  • Do not use the device if the integrity of the sterile packaging has been compromised or a loss of sterility is suspected.
  • Improper patient selection, surgical site preparation, or implantation may potentially cause device failure and/or adverse reactions.
  • The LATERA Absorbable Nasal Implant is not intended to replace normal healthy bone or cartilage.
  • Subsequent infection may require Implant removal.
  • Do not expose the LATERA Absorbable Nasal Implant to high temperatures and do not use if package temperature indicator shows exposure to temperature above 38 °C.
POSSIBLE ADVERSE EFFECTS
Adverse reactions typical to surgically implanted materials may occur. These include:
  • Inflammatory foreign body reaction, foreign body sensation, pain or discomfort, infection, and extrusion.
  • Excessive activity, trauma, or loading may lead to bending, fracture, loosening, and/or migration of the Implant.
  • Implants placed near the skin surface may be palpable or cause skin irritation.
  • Temporary hematoma from cannula insertion.
DISCLOSURES
  • The information provided is not intended to be used for medical diagnosis or treatment or as a substitute for professional medical advice. Please consult your physician or qualified health provider regarding your condition and appropriate medical treatment. Individual symptoms, situations and circumstances may vary.
  • Physician experience and individual patient results may vary.
  • The outcomes of case studies are not typical and cannot be generalized to all patients.
  • Certain physicians are consultants for Spirox and/or members of the company’s Scientific Advisory Board.