Spirox on Monday released 1-year results from a multi-center study of its Latera absorbable nasal implant, touting a significant reduction in nasal obstruction symptoms in patients with nasal valve collapse. Results from the study were presented at the 2016 Annual Meeting of the American Academy of Otolaryngology-Head and Neck Surgery this week. “Nasal valve collapse […]
Otolaryngology/Ear, Nose & Throat (ENT)
Medical society backs drug-eluting sinus implants
The American Rhinologic Society today endorsed the use of drug-eluting implants in sinus cavities for patients following surgery. A successful sinus surgery depends on proper healing and avoiding inflammation, the society said in a press release. Drug-eluting implants can reduce nasal polyps and inflammation, which can decrease a patient’s use of oral medication, according to […]
Med-El USA wins FDA nod for Synchrony EAS hearing implant
Med-El USA said today that it won pre-market approval from the FDA for its Synchrony electric acoustic stimulation hearing implant system. The Synchrony EAS uses both the Synchrony cochlear implant to stimulate the auditory nerve for high-frequency hearing loss and the Sonnet EAS audio processor for low-frequency hearing loss, the Durham, N.C.-based company said. “The […]
Acclarent wins FDA nod for Aera Eustachian tube balloon
Johnson & Johnson (NYSE:JNJ) subsidiary Acclarent said today that it won de novo clearance from the FDA for its Aera Eustachian tube balloon dilation system, designed to treat persistent Eustachian tube dysfunction. The Irvine, Calif.-based company’s Aera system consists of a balloon catheter designed to be inserted through the patient’s nose into the Eustachian tube. After insertion, the […]
FDA approves Cochlear’s Nucleus MRI-safe implant
Cochlear Ltd. (ASX:COH) said today it won FDA premarket approval for its magnetic resonance imaging-compatible Nucleus cochlear implant. The devices won clearance for use with up to 3.0T MRI machines with the unit’s magnet removed, and up to 1.5T machines with the use of the Centennial, Colo.-based company’s Cochlear Nucleus Implant Bandage and Splint Kit “Cochlear has […]
Cochlear shares dip despite huge gains in profit for FY2016
Cochlear Ltd. (ASX:COH) saw shares sag despite releasing fiscal year 2016 earnings today that showed annual net profit growing 30% while overall sales were up almost 25%. The Australian hearing aid giant reported profits of $144.9 million, or $2.54 per share, on sales of $888.6 million for the full 2016 fiscal year. That amounts to a […]
Intersect ENT files with FDA for drug-delivering sinus implant
Intersect ENT (NSDQ:XENT) said today it submitted a supplemental premarket approval submission to the FDA seeking approval for a new Nova steroid releasing implant for treating patients with chronic sinus disease. The new Nova device is designed with a lower profile to allow for placement in smaller sinus openings, and will expand the usable patient population for […]
Acclarent launches Relieva Scout multi-sinus dilator
Johnson & Johnson (NYSE:JNJ) subsidiary Acclarent said Wednesday it is launching the Relieva Scout multi-sinus dilation system in the U.S. The Relieva Scout is designed to use balloon sinuplasty technology to confirm and dilate sinus openings in individuals with chronic sinusitis through a minimally-invasive procedure. “I’m always looking for new technologies that enable me to […]
FDA clears Vent-Os sinus dilation devices from SinuSys
SinuSys said today it won FDA 510(k) clearance for 2 new Vent-Os sinus dilation devices designed for treating sinusitis symptoms. The Palo Alto, Calif.-based company said it won clearance for 2 new devices which allow dilation of the frontal and sphenoid sinuses. “The Vent-Os system is easy to deploy and enables physicians to bring the […]
EndoGastric Solutions touts U.S. reimbursement win
EndoGastric Solutions said today it won reimbursement coverage through U.S. health insurer Health Care Service Corporation for transoral incisionless fundoplication procedures using its EsophyX device, effective July 15. The EsophyX device is designed for the reconstruction of the gastroesophageal valve through a partial fundoplication procedure, performed transorally, the company said. The new medical policy through […]
Entellus expands distribution deal with Fiagon to include hospitals
Entellus Medical said today it expanded its distribution agreement with Fiagon NA to purchase and resell Fiagon’s surgical navigation systems, components and parts in the U.S. and its territories to now include hospitals. The expansion adds to the previous deal, inked last August, which made Entellus the exclusive distributor of certain Fiagon systems and parts to […]