Clinical Results: Balloon Sinus Dilation

BREATHE I study of FinESS™ balloon sinus dilation demonstrates clear clinical value

The clinical results below reflect findings from the BREATHE I multi-center study of FinESS balloon sinus dilation under local anesthesia.

Balloon Sinus Dilation: Lasting relief

FinESS balloon sinus dilation procedure improves quality of life related to sinusitis symptoms an average of 70% for at least 12 months.1

Balloon Sinus Dilation: Quick recovery

90% of patients able to return to normal activity within 48 hours of the procedure.2

No device-related serious adverse events or unanticipated adverse device effects were reported in BREATHE I.2 Other potential traditional endoscopic sinus surgery complications, such as bleeding requiring nasal packing, cerebrospinal fluid leak, and intraorbital complications, were not seen in the BREATHE I study.

Procedures come with a certain degree of risk. Possible adverse effects for FinESS sinus treatment include, but are not limited to, post-operative facial pain, loss of vision or double vision, damage to nerves potentially causing temporary (and occasionally prolonged) numbness to the cheek, lip or teeth, and facial bruising and swelling. To understand the risks associated with balloon sinus dilation, you should discuss the procedure and other treatment options with your doctor.

Contraindications for balloon sinus dilation

Patients with thickened polypoid mucosa excessive enough to inhibit the visualization of the maxillary ostium should not be considered candidates for the FinESS Sinus Treatment.

Further clinical reading on balloon sinus dilation and balloon sinuplasty

Links to further clinical reading are available on www.entellusmedical.com - click here to read more.

1 Stankiewicz, James MD, Truitt, Theodore MD, and Atkins, James MD. "One Year Results: Transantral balloon dilation of the ethmoid infundibulum" ENT Journal February 2010 Volume 89, Number 2.
2 Stankiewicz, James, et al. "Transantral, endoscopically guided balloon dilatation of the ostiomeatal complex for chronic rhinosinusitis under local anesthesia" Am J Rhinol Allergy; 23 1-00 (2009).