Its our pleasure to announce that the Sinusleeve® Balloon has been utilized in peer-reviewed Otolaryngology research by the University of Texas. You can find the paper here or review our excerpts below:
Chronic rhinosinusitis (CRS) affects millions of people in the United States with direct yearly costs in the billions of dollars.1-3 First-line treatment for CRS is medical therapy. For those who have failed medical therapy, endoscopic sinus surgery (ESS) remains a mainstay of treatment. Since 2005, balloon sinus dilation (BSD) procedures have become increasingly common for the treatment of CRS.4 In addition to standalone BSD procedures, balloon devices have been utilized in “hybrid” ESS procedures in an estimated 7.7% of sinus surgery cases.4 Proposed advantages of BSD as a standalone procedure or used in a hybrid balloon/ESS fashion are: improved mucosal preservation, decreased operating room time, and improved access in otherwise difficult sinonasal compartments (ie, posterior ethmoid, sphenoid, and frontal recess).5 Multiple studies have included analysis of BSD use during hybrid ESS procedures; however, these mostly refer to instances in which balloon devices and standard ESS techniques were utilized separately in the same patient.4, 6-14 In few studies, BSD has been implemented in a “true” hybrid fashion, in which balloon dilation is used as another surgical instrument to help achieve safe and efficient dissection of the paranasal sinuses.15-18
Recently, a novel BSD device, Sinusleeve (Dalent Medical, Miami, Florida), which can be placed over standard surgical instruments including surgical navigation instruments, has become commercially available (Figure 1). We propose that in specific surgical situations such as difficult frontal anatomy, tight posterior ethmoid/sphenoethmoid recess dissection, and in inflammatory cases with increased mucosal bleeding, a hybrid technique utilizing a BSD device placed over suction navigation instruments could be helpful. In this study, we report the first case series of 10 patients utilizing this novel BSD device in hybrid ESS procedures and detail several methods that its use may aid in improved visualization and surgical access.
This Sinusleeve sinus balloon device may be a useful adjunct during hybrid ESS procedures. This novel dilation system, which deploys a sinus balloon device over standard surgical instruments, including instruments with surgical navigation, provides even more opportunity to accurately dissect difficult areas of the paranasal sinuses safely and efficiently. Further studies evaluating the exact role of sinus balloon devices as a hydraulic dissection tool during FESS are warranted.
Overall, in our study, the rate of balloon failure was 1 out of 33 sites utilized, and at each site, the balloon was deployed 1 to 3 times. It should also be noted that the Sinusleeve does alter the geometry of the distal tip of the navigation tool. For a pre-calibrated instrument, the surgeon must recognize this difference in interpretation of the navigation views. Real-time calibration of instruments obviously would eliminate this issue. Additionally, the Sinusleeve device adds to the inherent diameter of any suction or navigation instrument in use. As such, in certain anatomic locations where space may be at a premium, such as during dissection of very narrow frontal outflow tracts or in areas of closely packed ethmoid cells, the device may have limited utility until more working room has been created via standard ESS techniques.
DISCLOSURE OF INTERESTS
Isaac L. Schmale has no disclosures. William C. Yao serves as a consultant for Stryker (Kalamazoo, Michigan) and is part of the Speaker's Bureau for Optinose, Inc (Yardley, Pennsylvania). Martin J. Citardi serves as a consultant for Acclarent (Irvine, California), Medical Metrics (Houston, Texas) MicroGenDX (Lubbock, Texas) and Stryker (Kalamazoo, Michigan).