New treatment options for chronic sinusitis

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1 New treatment options for chronic sinusitis Balloon Sinuplasty Technology Vishram Jalukar, MD Mason City Clinic ENT & Allergy MKT01014 Rev. D Sinusitis Overview Inflammation of the sinus lining caused by Bacterial, viral and / or microbial infections Structural issues Ostial blockage Common symptoms Nasal congestion Facial discomfort Nasal discharge Acute sinusitis Symptoms < 4 weeks Chronic sinusitis Symptoms > 3 months Beware the Migraine! Headache Fatigue

2 Chronic Sinusitis Clinical need drives innovation 900,000 patients not successfully treated Therapeutic Success 7M seek prescriptions 1.4M fail medications annually Only 35% of these undergo surgery Prevalence Afflicts estimated 37M U.S. More common heart disease or asthma Results in 18-22M physician office visits annually Quality of Life More debilitating than congestive heart failure or chronic back pain Is there opportunity to improve the patient care pathway? Current Chronic Sinusitis Care Pathway Waiting for things to get worse 7 M Medical Treatments Effective for 80% of patients 1.4 Sinusitis Patients 37 million sinusitis sufferers in USA $8 billion in direct cost * 7 million patients with chronic rhinosinusitis each year And the cycle starts again Patients continue drug therapy until symptoms make FESS no longer an optional procedure 900,000 Decline Surgical Therapy 900,000 decline annually No thanks Patients either ineligible for or averse to the FESS procedure Surgical Consult 20% of medical therapy patients ~1.4 million surgical consults per year

3 Traditional Treatment Options Surgical techniques Evolution of sinus surgery From open (Caldwell-Luc) to less invasive surgery (FESS) Introduction of endoscopic tools Discovery that blocked sinus ostia may be the primary culprit of this disease process Goals of FESS Clear blocked sinuses Restore normal sinus drainage and function Preserve normal anatomy and mucosal tissue Inherent limitations Removal of bone and tissue may lead to post-op pain, scarring, and bleeding Difficult or atypical anatomy Nasal packing may be used to control bleeding Delay in return to work or lifestyle Instrumentation is the key Rigid instrumentation Excellent for when the surgical goal is to remove bone and tissue Limited for when the surgical goal is to restore function with a maximum of bone and tissue preservation

4 Traditional Instrumentation and Approaches An Answer: Marry Endoscopic Techniques with New Technologies Advancements In Surgical Devices Continues Relieva Balloon Sinuplasty devices Designed for customized access Sinus Illumination System Sinus Guide Catheter Engineered for sinus dilation Sinus Balloon Catheter Developed for controlled inflation Sinus Balloon Inflation Device Designed for targeted local bathing of sinus cells MicroFlow Spacer

5 Preservation of Natural Structures: Balloon Dilation Place balloon catheter and dilate sinus 1. Advance balloon catheter 2. Inflate 1 balloon 2 3. Deflate balloon 3 4. Remove entire system 4 Images courtesy of Frederick Kuhn, MD

6 Preservation of Natural Structures: Balloon Dilation Balloon Sinuplasty Traditional Instrumentation Preservation of Natural Structures: Balloon Dilation of the Sphenoid Sinus

7 Preservation of Natural Structure: MicroFlow Spacers Temporary implant technology Delivered directly to the frontal or ethmoid sinuses Reservoirs with hundreds of micropores enable targeted, local bathing of paranasal sinus cells Frontal sinus implant Ethmoid sinus implant Preservation of Natural Structures: MicroFlow Spacer Implantation Empty micropore reservoir Filled micropore reservoir Fluid colored for purposes of illustration

8 Large Published Body of Literature Proves Safety, Efficacy and Quality of Life Benefits Foundational Studies Cadaver feasibility First-in-man balloon dilation Radiation investigations CLEAR Series & PatiENT Registry CLEAR 6mo CLEAR 1yr CLEAR 2yr 1036-pt Registry Proven safe Proven effective & durable Proven to improve QOL CLEAR results are generalizable Independent comparative Balloon dilation compares favorably to FESS Ongoing Basic & Advanced Technique Image guidance Frontal trephination Frontal fracture reduction Balloon dilation basics CLinical Evaluation to Confirm SAfety & Efficacy of Sinuplasty in the PaRanasal Sinuses (CLEAR) One-Year Study Trial Design Clinical Study Objective: To evaluate the durability of ostial patency and patients symptomatic improvement at one year following balloon catheter sinusotomy Methods: Prospective, multicenter evaluation (7 centers) Clinical assessment 1. Nasal endoscopy 2. CT Scan 3. Sino-Nasal Outcomes Test (SNOT-20) Kuhn, FA, et el. Balloon catheter sinusotomy: One-year follow-up Outcomes and role in functional endoscopic sinus surgery. Otolaryngology Head and Neck Surgery (2008) 139, S27-S37.

9 CLEAR One-Year Study Results Lund-MacKay CT Score (n = 53) 8.89 Nasal Endoscopic Evaluation (n = 202 sinuses) 1.95 Endoscopic patency Total 85% (172/202) Preop 1 Year (1) Statistically significant (p <0.001) Non-patent 1% (2/202) Functional Patency (CT L/M Score = 0) 13/28 Symptom Assessment SNOT-20 (n = 65) 2.14 Overall functional patency 91.6% (185/202) % functional patency for all dilated sinuses Preop 6 months 1 year (1) Statistically significant (p <0.001) (2) Clinically meaningful change (>0.8) Kuhn, FA, et el. Balloon catheter sinusotomy: One-year follow-up Outcomes and role in functional endoscopic sinus surgery. Otolaryngology Head and Neck Surgery (2008) 139, S27-S37. CLEAR One-Year Study Conclusions Endoscopic sinus surgery using balloon catheter technology is effective and durable One year results for balloon catheter sinusotomy compare favorably with standard endoscopic sinus surgical results: 91.6% overall sinus functional patency Clinical and statistically significant symptom improvements from baseline Balloon catheters have a place in sinusitis management Kuhn, FA, et el. Balloon catheter sinusotomy: One-year follow-up Outcomes and role in functional endoscopic sinus surgery. Otolaryngology Head and Neck Surgery (2008) 139, S27-S37.

10 CLEAR Two-Year Study Trial Design Clinical Study Objective: To assess two year postoperative clinical outcomes for patients receiving balloon catheter sinusotomy Methods: Prospective, multicenter evaluation (6 centers) Clinical assessment 1. CT Scan 2. Sino-Nasal Outcomes Test (SNOT-20) 3. Standardized patient questionnaire Weiss, RL, et el. Long-term outcome analysis of balloon catheter sinusotomy: Two-year follow-up. Otolaryngology Head and Neck Surgery (2008) 139, S38-S46. CLEAR Two-Year Study Patient Quality of Life Outcomes Symptom Assessment SNOT-20 (n = 61) 2.17 Lund-MacKay CT Score (n = 32) Preop 2 Year (1) Statistically significant (p <0.001) (2) Clinically meaningful change (>0.8) (3) Improvement reported at every time point 85% of patients reported significant symptom improvement Weiss, RL, et el. Long-term outcome analysis of balloon catheter sinusotomy: Two-year follow-up. Otolaryngology Head and Neck Surgery (2008) 139, S38-S46. Preop 2 Year (1) Statistically significant (p <0.001) No serious adverse events reported between one year and two years (n=65) Revision rates at two years 3.6% sinus revision rate (7/195) 9.2% patient revision rate (6/65)

11 CLEAR Two-Year Study Conclusions Balloon catheter sinusotomy achieves a statistically significant and clinically significant improvement in SNOT- 20 symptom scores at each time point through two years Patients reported clinical symptom improvement across the two-years period supporting the changes in the SNOT- 20 scores Resolution of disease on CT Scan previously observed at one year is also sustained in this two year analysis Weiss, RL, et el. Long-term outcome analysis of balloon catheter sinusotomy: Two-year follow-up. Otolaryngology Head and Neck Surgery (2008) 139, S38-S46. Multicenter Registry of Balloon Catheter Sinusotomy Outcomes for 1,036 Patients (PatiENT Registry) Study Goal Assess the safety & effectiveness of balloon catheters used as instruments in sinus surgery in a real-world multicenter registry- 1,036 patients, 27 US practices Study Results & Comparison CLEAR Study PatiENT Registry 27 sites n=1036 pts, 3276 sinuses Safety Efficacy 6 months 1 year No serious adverse events 91.6% functional 1 yr 2 years 40 weeks No serious adverse events 2.4% patient revision rate Patient Satisfaction SNOT-20 Score 2 yr (1) (1) Scores statistically significant and clinically improved at every time point over baseline 95.2% symptom improvement Levine, HL, et al, Multicenter Registry of Balloon Catheter Sinusotomy Outcomes for 1,036 Patients. Annals of Otology, Rhinology & Laryngology. April 2008; Vol. 117(4):

12 Balloon Sinuplasty Technology Comparison of Revision Rates 20% 15% 10% 5% 0% PatiENT Jakobsen CLEAR Hoffman Chiu Friedman Marks Lund Senior (2008) (2000) (2008) (1990) (2004) (2006) (1999) (1991) (1998) n Period 40 wks 1 yr 2 yr 9 mos 32 mos 72 mos 5 yrs 12 mos 1.5 yrs Summary of major studies on sinus surgery Traditional instruments vs. Balloon Sinuplasty TM technology Author Instruments # of pts Avg f/u Outcomes Complications Complications May, M et al. Traditional yrs 0.85% major complications 6.9% minor complications RomboutJ,deVriesN (Review of 26 articles) Bolger, W et al (multicenter prospective) Traditional 100 to 1500 n/a 1% major complications 5-6% minor complications Balloon 115 6mos 0 complications or adverse events (major, moderate, or minor) Levine H, et al (multicenter registry) Weiss, R, et al (multicenter prospective) Balloon mos. 0 major adverse events attributable to Balloon Sinuplasty instruments Balloon 65 2 yr 0 major adverse events Traditional FESS vs. FEDS* Author Study design Outcomes Symptoms & Post-Op Experience Friedman, et. al -Prospective, single-center - 70-patient comparative study, with arms matched by age, CT score, quality of life - 3-month follow-up 1. Significantly greater improvement in QOL for balloon dilation 2. 91% of patients would have FEDS again versus 49% for FESS 49% (p=0.0001) 3. Significant reduction in post-op narcotic pain meds: 0.80 days for FEDS vs for FESS (p=0.011) *FEDS = Functional Endoscopic Dilation of the Sinuses (using Balloon Sinuplasty TM technology) MKT01014 Rev. D

13 Chronic Sinusitis: Medical vs. Surgical Management Comprehensive, maximal medical management as primary treatment Considerations for candidacy: Recurrent acute infection Persistent chronic infection Intolerance of or Non-compliance with medical therapy Patient preference Final thoughts Balloon Sinuplasty technology offers a novel, endoscopic catheter-based approach Minimally invasive Safe and effective Reduced bleeding Fast recovery time Does not limit treatment options Clinically established Sources

14 Thank you Sources 1. Gliklich, R., et al, J Allergy Clin Immunol 1999; 113: US Census National Health Interview Survey, Lusk, R., et al, Laryngoscope 2006; 116: Benninger, M., Otolaryngol Head Neck Surg 2003; 129S: S1-S Bhattacharya, N. Laryngoscope 2006; 116S: S1-S Ray, N., et al, J Allergy Clin Immunol 1999; 103: Hamilos, J Allergy Clin Immunol 2000; Stankiewicz, J., et al, Am J Rhinol 2003; 17(3): Subramanian, H., et al, Am J Rhinol 2002; 16(6): Hessler, J., et al, Am J Rhinol 2007: 21(1): Millennium Research Group, USENT08, Acclarent, Inc. estimates based on US Census, 2007; National Health Interview Survey, 2006; Lusk, R., et al, Laryngoscope 2006; 116: ; Benninger, M., Otolaryngol Head Neck Surg 2003; S1-S32; Bhattacharya, N. Laryngoscope 2006; 116S: S1-S22; Hamilos, J Allergy Clin Immunol 2000; ; Stankiewicz, J., et al, Am J Rhinol 2003; 17(3): ; Subramanian, H., et al, Am J Rhinol 2002; 16(6): ; Hessler, J., et al, Am J Rhinol 2007: 21(1): 10-18; Millennium Research Group, USENT08, Vaughan, W., Wynn, R. Post-Operative Recovery After FESS with Balloon Sinuplasty. Presented at American Association of Otolaryngology Head and Neck Surgery Annual Meeting. September Safety & Feasibility of Balloon Catheter Dilatation of Paranasal Sinus Ostia: A Preliminary Investigation. Presented at American Rhinologic Society Annual Meeting. Nov Bolger, W., et al, Otolaryngol Head Neck Surg 2007; 137: Kuhn, F., et al, Otolaryngol Head Neck Surg 2008; 3S3: S27-S Weiss, R., et al, Otolaryngol Head Neck Surg 2008; 3S3: S38-S46. *Inflation adjusted