Chronic Sinusitis Robert Walsh

Sinus Anatomy  The Paranasal sinuses are paired hollow spaces surrounding the nasal cavity within the facial bones  The Paranasal Sinus has 4 major regions  Frontal Sinuses  Ethmoid Sinuses  Maxillary Sinuses  Sphenoid Sinuses  They are not fully developed until after age 12.

Sinus Function  Help decrease overall weight of the skull  Increase resonance of the voice  Provides buffer reducing damage from facial trauma  Humidifying and heating inhaled air  Regulation of intranasal and serum gas pressures  Immunological defense

Sinusitis  Generally considered an inflammation of the sinus cavities  Can be caused by sinus infection from virus, bacteria or fungus  Also caused by allergies or other irritation (chemical or particulate)  Affects 1 in 7 adults

Chronic Sinusitis  Inflammation of the sinus linings can block the natural drainage passageways leading to chronic infections and nasal obstruction.  Symptoms include:  Facial Pain/ pressure  Nasal congestion/ obstruction  Discolored nasal discharge  Loss of smell/ taste  Headache  Loss of sleep/ fatigue  Depression

Diagnosis  Examination of patient ear, nose and throat  Physician will try to determine if the sinusitis is caused by allergies, infections, or an obstruction  X-rays and CAT scan images may be taken to visualize the sinuses  Blood and allergy tests may be performed to determine route cause

Treatments  Medical Therapy- variety of medications are prescribed including oral steroids, nasal steroid sprays, antibiotics, decongestants and antihistamines.  Sinus Surgery- with persistent inflammation endoscopic surgery is used to enlarge the inflamed or obstructed sinus passageways.  Performed by Ear,Nose&Throat (ENT) surgeons  Remove inflamed bone and tissue and dilate sinus openings  Frequent post op visits are required to clean sinus cavities and ensure they are open, healing well and without scarring  Steroids may be prescribed to reduce inflammation

Post Surgery Sinus Stent History  Sinus stents first introduced in the 1950’s made from latex rubber- often caused tissue reactions causing scar tissue  Freeman stent introduced in the late 1980’s- design based on urinary catheter- didn’t solve the problem of recurrent polyposis, inflammation, or adhesion formation

Intersect ENT PROPEL  Propel dissolvable sinus implant coupled with controlled drug delivery directly to the sinus tissue.  Spring like design allows endoscopic delivery and expansion to fill cavity.  Steroid delivery (mometasone furoate) reduces inflammation and scar formation.  Implant made of synthetic bioabsorbable co-polymer, poly(L- lactide-co-glycolide), PLG

How It Works  PROPEL delivery system is directed to the open surgical cavity  Propel is released and conforms to patient’s unique anatomy propping open sinus  Sustained, local release of mometasone furoate for 30 days  Eventually dissolves

Post-Op  Post-Operative Care:  As part of routine post-operative care, frequent use of saline sprays, rinses or irrigations is recommended.  Routine debridement may be performed as part of the usual post-operative care.  In the unlikely event of a material related infection or rejection the implant may be removed at the discretion of the physician by use of suction, forceps or other surgical instruments.

Additional Information  Propel was FDA approved via PMA application on August 11, 2011  Chronic rhinosinusitis affects more than 30 million people in the United States  500,00 patients undergo sinus surgery each year costing 10,000$ per surgery  Propel costs 695$ per implant – more than 6,000 patients have been treated as of Feb 25, 2013  90% doctor satisfaction with implant  Next generation devices could stay in the noses of patients with sinus polyps for three months

Using Propel  Arrives sterilized and is stored at room temp  DIRECTIONS FOR USE  1. Remove the implant and delivery system from its protective packaging using sterile technique. Inspect for any obvious damage  2. The implant must be compressed and loaded into the tip of the delivery system prior to use.  Grasp the implant between the fingers of both hands and gently compress the implant.  Insert compressed implant into the funnel attached to the distal tip of the delivery system.  Carefully remove the funnel, taking care not to dislodge the implant from the tip of the delivery system.  The implant may be compressed and loaded into the delivery system tip up to two times.  Advance the Delivery System into the sinus cavity using endoscopic visualization. To insert the implant:  Ensure that the Delivery System is oriented so the distal tip is curved superiorly toward the posterior roof of the sinus cavity  b. Align the proximal end of the implant with the anterior edge of the middle turbinate.  c. Insert the implant by depressing the plunger while simultaneously withdrawing the delivery system.  4. Confirm final placement by endoscopic visualization. To adjust the position of the implant, use standard surgical instruments.

Sources  Intersect ENT  Kennedy DW. The PROPEL steroid releasing bioabsorbable implant to improve outcomes of sinus surgery. Expert Review of Respiratory Medicine. 2012; 6(5):  Rosenfeld et al. Clinical Practice Guideline: Adult Sinusitis. Otolaryngology - Head and Neck Surgery. Vol 137, No 3S, September 2007  American Academy of Otolaryngology – Head and Neck Surgery (AAO-HNS) website  Rosenfeld RM, et al. Clinical Practice Guideline: Adult Sinusitis. Otolaryngology – Head and Neck Surgery. (2007) 137, S1-S31.