• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Intersect ENT updates on Sinuva steroid-releasing sinus implant

May 22, 2017 By Sarah Faulkner

Intersect ENTIntersect ENT (NSDQ:XENT) said today that the FDA is slated to make a decision on its new drug application for the Sinuva steroid-releasing sinus implant by January 7, 2018.

The Sinuva implant, which was previously called the Resolve implant, is placed during an in-office doctors appointment and is designed to be a treatment option for patients with recurrent ethmoid sinus obstruction. Traditionally, treatment for the condition includes high-dose oral steroids and repeat surgery.

“The SINUVA implant offers the potential to provide a less invasive and more cost-effective solution, performed easily in the doctor’s office, for patients suffering from persistent chronic sinusitis,” president & CEO Lisa Earnhardt said in prepared remarks. “We are excited that FDA’s filing of this NDA advances us a step closer to bringing this important innovation to ENT physicians and their patients.”

Sinuva is Intersect’s 4th steroid-releasing implant. The device was assessed in 4 clinical trials to evaluate safety and efficacy.

Resolve II, the company’s pivotal study, examined the implant in 300 adult chronic sinusitis patients who were indicated for revision sinus surgery at the start of the study.

Patients were randomized into 2 groups – a treatment group that received bilateral Sinuva implant placement and a control group that received a sham procedure. Both groups of participants continued to receive standard treatments, including topical nasal steroid sprays.

The trial met both co-primary efficacy endpoints, according to Intersect ENT, and demonstrated a statistically significant reduction in nasal congestion and polyp burden. The trial also met its secondary endpoints, including a reduction in the proportion of patients still indicated for repeat sinus surgery and improvements in nasal obstruction symptoms and sense of smell.

XENT shares were trading at $23.10 apiece in mid-afternoon activity today, up +1.5%.

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Implants, Otolaryngology Ear, Nose & Throat, Wall Street Beat Tagged With: Intersect ENT Inc.

IN CASE YOU MISSED IT

  • Tandem Diabetes Care wins CE mark for Mobi insulin pump with Control-IQ+ technology
  • Glooko adds chief strategy officer to chief medical officer’s title
  • Cordis launches 10,000-patient registry for drug-eluting balloon
  • Senseonics opens $50M public offering, $25M private placement with Abbott
  • Study links Abbott CGM use to lower risk of hospitalizations due to heart complications

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS