FAQs

Using Simplicity Sinus Dilators

The Simplicity Sinus Dilators were designed to fit easily in your hands whether you are right or left handed. As stated in our Instructions for Use, the best way to hold the sinus dilators is in a pen-grip.

Sinus Dilator Instructions

In the hands of a trained Otolaryngologist or other specialist familiar with sinus surgery, the Simplicity Sinus Dilators may feel familiar and intuitive when finding and dilating the ostia of the frontal, sphenoid, and maxillary sinuses. The Simplicity Sinus Dilators may be used like other rigid sinus instruments, such as the Sinus Seeker®, an instrument that is central to standard functional endoscopic sinus surgery. The tips of the Simplicity Sinus Dilators are gently positioned and then inserted into the applicable sinus during the dilation procedure. The Simplicity Sinus Dilators have distinct fixed tips angles facilitating access to the different presenting ostial anatomy.

Some physicians using the Simplicity Sinus Dilator have suggested that the dilator itself be utilized to medialize the uncinate. Other physicians have used a Sinus Seeker® or other similar instrument to palpate the maxillary and frontal ostia and medialize the uncinate. The physician uses the solution most appropriate for their patient and circumstances.

Yes when designing the Simplicity Sinus Dilators we used CT measurements, cadaver heads, endoscopic confirmation, and 3D models based on CT scans of patients to make the dilators long enough to extend into the designated sinus.

The Simplicity Solid Dilators the dilators are tapered with a tip that is just 1 mm in diameter and enlarges gradually forming a smooth transition to the selected dilation diameter. It is recommended that you start the dilation process with the smaller 2mm dilator to ensure a safe transition to the patient-appropriate diameter. Please reference our Sinus Dilation Video to see how this is done. Furthermore, as shown in the following video of a 4 mm dilator being used, the Simplicity Sinus Dilators fit easily into the maxillary, frontal, and sphenoid sinuses during dilation procedures.

 

Simplicity Sinus Dilators do not require cutting of nasal bone or tissue nor any manipulation or inflation of extended devices. During sinus dilation, a Simplicity Dilator is positioned and used to gently open the sinus passageways, facilitating drainage of the mucus buildup. They widen the sinus passageway, while maintaining the integrity of the sinus lining. Most of our patients that underwent sinus dilation have reported clinically meaningful improvement in sinus symptoms and quality of life.* The Simplicity Dilators can be used with one hand and used in conjunction with endoscopes.

*When compared to pre-operative symptoms. Data on file.

Clinical Info

Simplicity Sinus Dilators are specifically designed for sinus dilation of the frontal, sphenoid, and maxillary sinuses. The Simplicity Sinus Dilator sizes range from 2mm to 5 mm, allowing you to incrementally dilate the sinuses.

Our main concern in designing the Simplicity Sinus Dilators was determining whether they were safe and effective. We have achieved this through several design iterations and rigorous Design Verification testing. The Simplicity® Dilators are rigid instruments that allow for precise tip control during dilation, resulting in minimal trauma. We are proud to state that in one medical practice in the USA, which has adopted the use of the Simplicity Sinus Dilators has performed sinus dilations on over 500 patients with no major complications. Furthermore, the associated clinical observations have demonstrated low procedural bleeding and localized mucosal trauma. The familiar and intuitive design of the Simplicity® Dilators, allows the dilation process to have an uninterrupted natural flow from insertion to ostial dilation.

*When compared to pre-operative symptoms. Data on file.

From the American Academy of Otolaryngology—Head and Neck Surgery or Foundation Position Statement entitled “Dilation of sinuses, any method (e.g., balloon, etc.)” adopted 6/28/2010.
“Sinus ostial dilation (e.g. balloon ostial dilation) is an appropriate therapeutic option for selected patients with sinusitis. This approach may be used alone to dilate a sinus ostium (frontal, maxillary, or sphenoid) or in conjunction with other instruments (eg, microdebrider, forceps). The final decision regarding use of techniques or instrumentation for sinus surgery is the responsibility of the attending surgeon. http://www.entnet.org/content/position-statement-dilation-sinuses-any-method-eg-balloon-etc

Yes, the Simplicity Dilators® are registered with the FDA and have fulfilled applicable requirements. See also the FDA Simplicity Registration Information

Technical Info

Simplicity sinus dilators have a one year manufacturer warranty with a maximum suggested three year use life.

Simplicity Sinus Dilators are made from medical grade stainless steel parts, which are easily cleaned and sterilized for multiple uses.

The Simplicity “Solid” Dilators are completely solid and are entirely made of medical grade stainless steel. The Simplicity “Suction” Dilators include a hollow lumen and a high quality vacuum connection port that is used to provide suction during dilation procedures. Additionally the Simplicity Sinus Dilators may be used for irrigation, or in conjunction with other medical devices, such as fiber optic cameras, through the Simplicity Suction Dilators.

Cost, Payment Options, Reimbursement

Results vary based on your volume of sinus dilation procedures and the types of legacy sinus dilators that you use. In one example, a clinic that performs 20 dilations per month and pays $1,200 per disposable device may have a yearly expense of approximately $288,000. If the clinic purchased two Simplicity® Solid and Suction Dilator sets to rotate, the clinic would pay just $35,000 total. The physician would cover the total cost of dilators in approximately 29 cases, and save over $253,000 per year while decreasing expenses and increasing profits. One medical group using Simplicity Sinus Dilators saves $450k per year and has saved over 1.5 million on other dilation devices so far.

Yes, please email Info@SimplicityDevices.com or call 801-822-2143 for different payment options, such as monthly payments via check, credit card, or PayPal. We are happy to work with you. Some payment options may include a convenience fee.

Yes, most insurance companies and Medicare allow for the billing of dilation of the maxillary, frontal, and sphenoid sinuses.

The designated codes have thus far been:
31295 Nasal/sinus endoscopy, surgical; with dilation of maxillary sinus ostium (eg, balloon dilation), transnasal or via canine fossa
31296 Nasal/sinus endoscopy, surgical; with dilation of frontal sinus ostium (eg, balloon dilation)
31297 Nasal/sinus endoscopy, surgical; with dilation of sphenoid sinus ostium (eg, balloon dilation)