References
1. Chandra RK, Kern RC, Cutler JL, et al. REMODEL larger cohort with long-term outcomes and meta-analysis of standalone balloon dilation studies. Laryngoscope. 2016;126(1):44-50.
2. San Nicolo M, Stelter K, Sadick H, et al. Absorbable implant to treat nasal valve collapse. Facial Plast Surg. 2017;32:233-240.
3. Data on file. Entellus Medical, Inc. 2018 Investors deck 1808-108 rA slide 7.
4. Rudmick L, et al. Rhinology-specific priority setting for quality improvement: a modified Delphi study from the Quality Improvement Committee of the American Rhinology Society. Int Forum Allergy Rhinol. 2017; 7(10): 937-944.
5. American Academy of Otolyaryngology --Head and Neck Surgery. Chronic sinusitis patients experience improved quality of life after endoscopic sinus surgery. Science Daily. 01.04.2010. https://www.sciencedaily.com/releases/2010/01/100101011826.htm. Accessed March 2020.
6. Data on file. Entellus Medical, Inc. 2016 ENT Journal Survey.
7. Kivekas I, Chao WC, Faquin W, et al. Histopathology of balloon dilation Eustachian tuboplasty. Laryngoscope. 2015;125:436-441.
8. Data on file. Entellus Medical, Inc. ET Balloon Dilation Clinical Evidence Summary, 1693-130 rA.
9. Silvola J, Kivekas I, Poe DS. Balloon dilation of the cartilaginous portion of the Eustachian tube. Otolaryngol Head Neck Surg. 2014;151(1):125-130.
10. Meyer TA, O'Malley EM, Schlosser RJ, et al. A randomized controlled trial of balloon dilation as a treatment for persistent Eustachian tube dysfunction with 1-year follow-up. Otol Neurotol. 2018; 39(7):894-902.
11. 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. Int J Gen Med. 2010; 3:37-45.
12. San Nicolo M, Stelter K, Sadick H, et al. Absorbable implant to treat nasal valve collapse. Facial Plast Surg. 2017;32:233-240.
13. Sufyan A, Ziebarth M, Crousore N, et al. Nasal batten grafts: are patients satisfied? Arch Facial Plast Surg. 2012;14:14-19.
14. Ramakrishnan JB, Danner CJ, Yee SW. The use of porous polyethylene implants to correct nasal valve collapse. Otolaryngol Head Neck Surg. 2007;136:357-361.
15. Lipan MJ, Most SP. Development of a severity classification system for subjective nasal obstruction. JAMA Facial Plast Surg. 2013;15:358-361.
16. San Nicolo M, Stelter K, Sadick H, et al. Absorbable implant to treat nasal valve collapse. Facial Plast Surg. 2017;32:233-240.
17. Becker SS, Dobratz EJ, Stowell N, et al. Revision septoplasty: review of sources of persistent nasal obstruction Am J Rhinol. 2008; 22:440-444.
18. Rhee JS, et al. A systematic review of patient reported nasal obstruction scores: defining normative and symptomatic ranges in surgical patients. JAMA Facial Plast Surg. 2014; 16(3): 219-232.
19. Stewart MG, Witsell DL, Smith TL, et al. Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg. 2004; 130:157-163.
20. San Nicoló M, Stelter K, Sadick H, et al. A 2-year follow-up study of an absorbable implant to treat nasal valve collapse. Facial Plast Surg. 2018; 34:545-550.
21. Stolovitzky P, Sidle DM, Ow RA, et al. A prospective study for treatment of nasal valve collapse due to lateral wall insufficiency: outcomes using a bioabsorbable implant. Laryngoscope. 2018; 128:2483-2489.
22. Dutton JM. Rhinoplasty (Functional). American Rhinologic Society website. http://care.american-rhinologic.org/rhinoplasty_functional. Accessed August 2018.
23. Fanous N, Brousseau VJ, Karsan N, et al. Predicting the results of rhinoplasty before surgery: easy noses versus difficult noses. Can J Plast Surg. 2008;16(2):69-75.
24. Crawford-Brown. Theoretical and Mathematical Foundations of Human Health Risk Analysis; 1997, Page 103.
25. Rhee JS, Poetker DM, Smith TL, et al. Nasal valve surgery improves disease-specific quality of life. Laryngoscope. 2005; 115(3):437-40.
26. Wever C. The nasal airway: a critical review; Facial Plast Surg. 2016; 32:17–21.
27. Camacho M, Riaz M, Capasso R, 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. 2015; 38(2):279-286.
28. Constantian MB, Clardy RB. The relative importance of septal and nasal valvular surgery in correcting airway obstruction in primary and secondary rhinoplasty. Plast Reconstructive Surg. 1996; 98(1) 38-54.
29. Ricci E, Palonta F, Preti G, et al. Role of nasal valve in the surgically corrected nasal respiratory obstruction: evaluation through rhinomanometry. Am J Rhinol. 2001; 15(5):307-310.
30. Marino MJ, Ling LC, Yao WC, et al. Eustachian tube dysfunction symptoms in patients treated in a tertiary rhinology clinic. Int Forum Allergy Rhinol. 2017;7(12):1135-1139.
31. References and/or published data on file at Entellus Medical, Inc. 3748-001 rev B.
32. Jacques SL. Optical properties of biological tissues: a review. Phys Med Bio. 2013; 58(11): R37-R61.
33. American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS). Position Statement: Intra-Operative Use of Computer Aided Surgery. https://www.entnet.org/content/intra-operative-use-computer-aided-surgery. Updated March 2, 2014. Accessed Mar 31, 2020.
34. Park BK, Kim MM. Applications of chitin and its derivatives in biological medicine. Int J Mol Sci. 2010;11:5152-5164.
35. Rippy MK, Baron S, Rosenthal M, Senior BA. Evaluation of absorbable PLA nasal implants in an ovine model. Laryngoscope Investig Otolaryngol. 2018; 3(3):156-161.
36. CDC. Allergies and Hay Fever. https://www.cdc.gov/nchs/fastats/allergies.htm. Revised January 20, 2017. Accessed March 13, 2020.
37. Settipane RA, Charnock DR. Epidemiology of rhinitis: allergic and nonallergic. Clin Allergy Immunol. 2007;19:23–34.
38. Glaxco Smith Kline. What are nasal steroid side effects? https://www.flonase.com/allergies/nasal-steroid-side-effects/. Accessed March 13, 2020.
39. U.S. National Library of Medicine. Nasal Corticosteroid Sprays. https://medlineplus.gov/ency/patientinstructions/000404.htm. Updated November 19, 2017. Accessed March 13, 2020.
40. Hwang PH, et al. Cryosurgical posterior nasal tissue ablation for the treatment of rhinitis. Int Forum Allergy Rhinol. 2017; 7(10):952-956.
41. Sunderland S. Nerves and Nerve Injuries. Edinburgh & London: Livingstone (1968): 180.
42. Cooper SM, Dawber RP. The history of cryosurgery. J R Soc Med. 2001; 94:196-201.
43. Gage AA, Baust JM, Baust JG. Experimental cryosurgery investigations in vivo. Cryobiology. 2009; 59:229-243.
44. Leila R, Raluca P, Yves DG, et al. Cryoablation versus radiofrequency ablation in AVNRT: same goal, different strategy. J Neurol Disord. 2015; 8(1):1220.
45. Hsu M. Significance of clinical treatments on peripheral nerve and its effect on nerve regeneration. J Neurol Disord. 2014; 2:168.
46. Brain DJ. Cryosurgery in benign conditions of the nose and throat. Proc R Soc Med. 1974; 67:72-76.
47. Kellerhals B, Schlageter J. Cryosurgery in vasomotor rhinopathy: experimental histopathology. ORL. 1976; 38:157-163.
48. Chang MT, Song S, Hwang PH. Cryosurgical ablation for treatment of rhinitis: a prospective multicenter study. Laryngoscope. 2019 Sep 30: DOI:10.1002/lary.28301 [E-pub ahead of print]
49. LBL-0660 Rev D 10/2019 ClariFix® Device Indications for Use, CFXII.
50. Yan CH, Hwang PH. Surgical management of nonallergic rhinitis. Otolaryngol Clin N Am. 2018;51:945-955.
51. Meltzer EO, Blaiss MS, Naclerio RM, et al. Burden of allergic rhinitis: allergies in America, Latin America, and Asia-Pacific adult surveys Allergy Asthma Proc. 2012;33: S113-S141.
52. Shan, A., Ward, B. K., Goman, A. M., Betz, J. F., Reed, N. S., Poe, D. S., & Nieman, C. L. (2019). Prevalence of Eustachian Tube Dysfunction in Adults in the United States. JAMA otolaryngology-- head & neck surgery, 145(10), 974–975. Prevalence of Eustachian Tube Dysfunction in Adults in the United States
53. Vila PM, Thomas T, Liu C, Poe D, Shin JJ. The burden and epidemiology of Eustachian tube dysfunction in adults. Otolaryngol Head Neck Surg. 2017;156:278-284.
54. Schilder AG, Bhutta MF, Butler CC, et al. Eustachian tube dysfunction: consensus statement on definition, types, clinical presentation and diagnosis. Clin Otolaryngol. 2015;40:407-411
55. Clinical and economic evidence for balloon dilation for the treatment of persistent Eustachian tube dysfunction. Stryker document #1693-130 rE, February 2020
56. Dinç AE, Damar M, Uğur MB, et al. Do the angle and length of the Eustachian tube influence the development of chronic otitis media? Laryngoscope. 2015;125(9):2187-2192. 7.
57. Poe DS, Hanna BMN. Balloon dilation of the cartilaginous portion of the Eustachian tube: initial safety and feasibility analysis in a cadaver model. Am J Otolaryngol. 2011;32(2):115-123.
58. Cutler JL, Meyer TA, Nguyen SA, O'Malley EM, Thackeray L, Slater PW. Long-term outcomes of balloon dilation for persistent Eustachian tube dysfunction. Otol Neurotol. 2019;40(10):1322-1325
59. Standring RT, O'Malley EM,Greene JB, Russell JL, McCoul ED. Balloon dilation of theEustachian tube with a seeker-based device: A registry of 169patients.Laryngoscope Investigative Otolaryngology. 2021;6(5):975-982. doi:10.1002/lio2.652982STANDRINGET AL.
60. Data on file at Stryker (DHF 2266-001 r01).
61. Data on file at Stryker (DHF 2265-001 r01).
62. Data on file at Stryker (DHF 2267-001 r01).