MINNEAPOLIS--(BUSINESS WIRE)--Apr 19, 2012-- One-year results presented by Dr. David Brodner today during the annual Combined Otolaryngology Spring Meeting in San Diego demonstrate that the Entellus Medical(TM) XprESS(TM) Multi-Sinus Dilation Tool may be used safely and with sustained effectiveness to treat sinusitis patients who exhibit obstruction in multiple sinuses. The data affirm the durability of the one-month results as patients continue to experience a statistically significant improvement in their sinusitis symptoms at one year.
The presentation, entitled "One-year Outcomes and Ostial Patency Following Treatment with a Multi-function, Multi-sinus Balloon Dilation Tool," reviewed clinical data from a multi-center prospective study of 175 patients who underwent balloon dilation of the frontal recess, sphenoid ostium and maxillary ostium/ethmoid infundibulum to examine the safety of the XprESS device. In 96% of the 497 targeted sinuses, doctors were able to successfully open the obstructed sinus.
The XprESS device also demonstrated an excellent safety profile, as no serious adverse events were reported. The first 50 patients enrolled were scheduled to complete assessments one year post-procedure to analyze long-term effectiveness. One year results affirmed persistent relief of sinusitis symptoms as 92% of the sinuses treated with balloon dilation remained open, and only 2.3% of patients required a revision surgery.
The Entellus XprESS Multi-Sinus Dilation Tool is used for the treatment of the frontal, sphenoid and maxillary sinuses either alone or as part of a traditional FESS. XprESS combines a balloon catheter with a malleable sinus seeker that can be customized based on patient anatomy, and enables a physician to efficiently and cost-effectively access and use balloon dilation to treat multiple sinuses with a single device while potentially reducing the amount of tissue loss compared to traditional FESS procedures.1,2,3 According to Dr. Brodner, "XprESS is an easy-to-use technology that provides physicians with a versatile, more ergonomic tool to treat chronic sinusitis patients. These long-term results demonstrate that XprESS is safe and provides patients durable relief from sinusitis-related symptoms." About Entellus Medical: Entellus Medical (www.EntellusMedical.com) provides complete solutions for the minimally invasive treatment of chronic and recurrent sinusitis patients and is leading the way with easy-to-use, cost-effective products designed for office-based balloon dilation of narrowed sinus pathways. With this approach, Entellus sinus dilation products also provide significant efficiency and cost-effectiveness for sinus dilation procedures performed in operating rooms. For more information on XprESS(TM) Multi-Sinus Dilation Tool, FinESS(TM) Sinus Treatment, or PathAssist(TM) sinus confirmation tools visit http://www.EntellusMedical.com.
1 James Stakiewicz, et.al. Transantral, Endoscopically Guided Balloon Dilation of the Ostiomeatal Complex for Chronic Rhinosinusitis Under Local Anesthesia, Am. J. Rhinol. Allergy 23, 1-00 (2009) 2 Ahmet Kutluhan, et.al., Endoscopic Balloon Dilation Sinuplasty Including Ethmoidal Air Cells in Chronic Rhinosinusitis, Annals of Oto, Rhin and Lary 118(12):881-886 (2009).
3 Kevin C. Welch, et.al., A Contemporary Review of Endoscopic Sinus Surgery: Techniques, Tools, Outcomes, 119 Laryngoscope 2258-68 (Nov.
2009) CONTACT: Entellus Medical Mike Gaynes, 650-728-0227 firstname.lastname@example.org KEYWORD: UNITED STATES NORTH AMERICA MINNESOTA INDUSTRY KEYWORD: SURGERY PRACTICE MANAGEMENT HEALTH CLINICAL TRIALS HOSPITALS MEDICAL DEVICES SOURCE: Entellus Medical Copyright Business Wire 2012 PUB: 04/19/2012 12:15 PM/DISC: 04/19/2012 12:15 PM http://www.businesswire.com/news/home/20120419006203/