Entellus Medical Announces Multi-Center Clinical Study Publication Confirming Nasal Obstruction Symptom Improvement from LATERA
MENLO PARK, Calif., May 31, 2018 (GLOBE NEWSWIRE) -- Entellus Medical, Inc., now a part of Stryker, today announced the publication of positive data from prospective, multicenter OR and Office studies of LATERA for patients with symptoms of Nasal Valve Collapse (NVC) due to lateral wall insufficiency (LWI). Results show that patients treated with LATERA had statistically significant improvements in symptom burden at 1,3, and 6 months post-procedure, as measured by validated scales, including NOSE Scores. For these first 101 patients, symptom reduction of LATERA alone and LATERA plus additional procedures to correct septal deviation and/or turbinate hypertrophy is within the range of other nasal obstruction techniques, including traditional grafting techniques1. The data appear in the latest issue of Laryngoscope.
NVC is as prevalent as septal deviation and turbinate hypertrophy among nasal airway obstruction (NAO) patients.2 However, NVC is significantly undertreated due to limitations in current tools and techniques. With LATERA, a bio-absorbable implant, the ability to address the symptoms of NVC is accessible to more physicians and patients through a minimally invasive, safe and predictable procedure.
“In this study, patients seeking treatment with LATERA alone to address their symptoms of NVC were more likely to have undergone prior septal or turbinate procedures. We believe that this may have been due to a missed diagnosis of NVC,” said Douglas M. Sidle, MD, FACS, Assistant Professor, Feinberg School of Medicine, Northwestern University, and an investigator in the study. “Study data show that LATERA resulted in short and mid-term improvements in nasal obstructive symptoms in patients suffering with NVC. These findings suggest that NVC should be addressed to provide patents with the more complete relief from their NAO symptoms.”
Data for the study were collected from the first 101 consecutive patients enrolled between September 2016 and March 2017 at 14 institutions across the United States in two prospective, multicenter, single-arm studies designed to obtain outcomes for LATERA. Medical history, symptom evaluation, NVC assessment, patient-derived assessments and endoscopic lateral wall motion video were captured at the baseline visit. Patients were treated with LATERA with or without concurrent septal and/or turbinate procedures. Follow-up assessments were performed at 1, 3 and 6 months. These results represent an interim view of the first 101 subjects reaching 6 months.
Key findings from the study include:
- 89.7% of patients were deemed to be responders to LATERA at 6 months postoperatively. Positive responder rates at 6 months were 89.2% and 90% for the subgroups of standalone and concomitant procedures, respectively.
- Positive reductions in NOSE scores were observed at 6 months postoperatively in patients receiving LATERA (79.5 at pre-procedure baseline and 30.6 at 6 months, p<0.01). Similar reductions were observed in the subgroups of standalone (80.0 at baseline and 39.6 at 6 months) and concomitant (79.1 at baseline and 24.0 at 6 months, p<0.01 for both) procedures.
- Significant reductions in VAS scores were observed at 6 months postoperatively in patients receiving LATERA (71.9 at pre-procedure baseline and 30.7 at 6 months, p<0.01). Similar reductions were observed in the subgroups of standalone (75.2 at baseline and 39.0 at 6 months) and concomitant (69.4 at baseline and 24.5 at 6 months, p<0.01 for both) procedures.
- The study also affirmed the strong safety profile for LATERA, with no major adverse device events and no unresolved minor events. There were a total of 19 procedure or implant related adverse events reported in 17 patients. All were low risk and resolved with no clinical sequelae. These events included inflammation, foreign body sensation, skin irritation, hematoma, infection, and implant retrievals. The investigators confirmed the implant retrievals were not due to adverse physiologic tissue rejection.
“These positive, prospective clinical trial results add to the growing body of data that support the clinical utility and favorable safety profile of LATERA,” said Don Gonzales, MD, Entellus Chief Medical Officer. “The data confirm that this novel implant is an important advance for patients suffering from symptoms of NVC. We look forward to presenting additional data from this study and other ongoing studies in the future.”
1 Rhee et al. 2014. A systematic review of patient reported nasal obstruction scores: Defining normative and symptomatic ranges in surgical patients. JAMA Facial PlastSurg., 16(3): 219-232.
2 Market research data on file (TR-21076 Spirox NVC Experience)
LATERA® is an absorbable nasal implant that supports the lateral nasal cartilage (side wall of the nose). LATERA addresses the symptoms of nasal valve collapse (NVC) and may reduce nasal airway obstruction (NAO) symptoms, helping patients breathe better. Through a minimally invasive procedure, the nasal implant is inserted through a small incision made inside a patient’s nose. Patients who received the implant reported satisfaction with their breathing (86%) and appearance (93%) results. Recent 18 and 24-month data has demonstrated durable relief of NAO symptoms with LATERA with no negative cosmetic changes.
For more information about the LATERA device including the indications for use, contraindications and warnings, please see the LATERA IFU [http://www.spiroxmed.com/wp-content/uploads/2016/10/LATERA_IFU.pdf] on https://latera.com/.
About Entellus Medical, Now a Part of Stryker
Entellus is a medical technology company focused on delivering superior patient and physician experiences through products designed for less invasive treatment. Entellus products are used for the treatment of adult and pediatric patients with chronic and recurrent sinusitis, patients with nasal airway obstruction, as well as adult patients with persistent Eustachian tube dysfunction, and combine to enable ENT physicians to conveniently and comfortably perform a broad range of procedures in the most cost effective and efficient site of care. Entellus was acquired by Stryker in February of 2018.
Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.
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