Intersect ENT Inc. announced a landmark win for its flagship Propel drug-eluting implant for treatment of chronic sinusitis.
The Palo Alto, Calif.-based company’s device claims to be the first of a new category of devices offering localized, controlled steroid delivery directly to sinus tissue.
Chronic sinusitis is a common condition affecting on in seven U.S. adults and frequently requires a combination of surgical and medical treatments, according to a press release. While surgery is often effective, as many as 25 percent of patients require revision surgery to clear recurrent obstruction of the airways.
Propel is implanted during sinus surgery, propping open the sinuses in a "spring-like" fashion that conforms to the individual’s cavity to delivery anti-inflammatory medication as the implant dissolves.
- Arthrocare gets FDA nod for fixation device
Austin, Texas-based ArthroCare Corp. (NSDQ:ATRC) landed FDA clearance for its SpeedLock Knotless fixation device, a push-in implant for soft tissue to bone fixation. The device boasts independent bone lock, suture tensioning and suture lock, and is primarily indicated for use in shoulder repair procedures.
- Rotem Inc. touts FDA clearance for hemostasis analyzer
Research Triangle Park, N.C.-based Rotem Inc. announced FDA clearance for its full suits of assays for its new hemostasis analysis system. The device, which analyzes patient blood coagulation rates, has been around in more than 50 countries since 2003.
- Nephros files 510(k) for hemodiafiltration system
River Edge, N.J.-based therapeutic filtration company Nephros Inc. (OTC:NEPH) announced that it filed a 510(k) application for clearance of its hemodiafiltration system for end-stage renal disease. The company landed FDA clearance to market biofiltration systems for solutions used in hemodialysis procedures just last month.