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 http://www.intersectent.com/

Kennedy DW. The PROPEL steroid releasing bioabsorbable implant to improve outcomes of sinus surgery. Expert Review of Respiratory Medicine. 2012; 6(5):493-498.

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.