Yet Another Sinus Dilation Device - AerOS Sinus Dilation System

Sinus dilation has become all the rage in the past few years to treat chronic sinusitis, especially since CPT codes for this procedure has become available as of January 2012.

The first company was Acclarent who coined the balloon sinuplasty term.

Next was Entellus who produced their simpler system (XprESS and FinESS).

Now, there is SinuSys who has produced a new way to dilate the sinus opening without use of a balloon like Acclarent and Entellus. It is currently pending FDA approval, but is used in Europe.

This new system is called AerOs Sinus Dilation System and utilizes an osmotic self-expanding technology. A "simple" two-step insertion and removal of the device is required. Once inserted, the device gradually expands via low-pressure osmotic pressure in about 60 minutes. At that point, it can be removed.

The device itself is 5mm in size and exerts pressure of 2.5 ATM. The diameter is 3mm before dilation that ultimately expands to 5mm.

Compare this with Acclarent and Entellus balloon devices which are inflated to 12 ATM pressure and expands up to 7mm in size (depending on the model).

My personal concern with this device is the small size of 5mm... the surgeon will have to be super-precise for placement, otherwise, it'll fall out or do nothing.

Also, I question whether a 2mm dilation will actually make any difference. Prior studies have established that 4-5mm ostia size really is the minimal efficacious opening size. Larger is better, especially when the uncinate process is still intact as it would be in pure dilation cases. More study is required.

In any case, when (or if) this new device becomes available in the USA is unclear. It's all up to the FDA now.

Reference:
Feasibility of an osmotically driven, self-expanding device for sinus dilation to treat chronic sinusitis. Poster Presentation

Assessment of the short term patency of the maxillary sinus ostium following dilatation with an osmotic device in a sheep model. Jerome E. Hester, MD, David Edgren, BS, Andrea Koreck, MD, PhD, Jason Fox, BS, Janie Mandrusov, PhD, East Palo Alto, CA USA (Annual Meeting of American Rhinologic Society, September 2012, Poster# P-7).

Treatment of Maxillary Sinusitis Using the SinuSys AerOsTM Sinus Dilation System. White Paper