SinuSys Corporation (Palo Alto, CA) has received the go-ahead in the EU to market its AerOs Sinus Dilation System, a device developed for opening up the sinus ostia to restore proper drainage and ventilation.
The company lauds the AerOs for its slow expansion, unlike balloon dilators that can be uncomfortable and may require general anesthesia. The tiny device is inserted by the physician and set to expand, while the patient plays a round of Angry Birds, and sixty minutes later it has fully expanded and ready for removal.
More from SinuSys:
The Company has shipped devices to the United Kingdom in the first phase of its European commercialization strategy, while it completes its initial clinical study in Canada and awaits a response to its FDA 510(k) submission.
The AerOs device incorporates the Company’s proprietary osmotic technology, which utilizes the body’s natural fluids to expand the insert.
- Simple two-step insertion and removal
- Gradual, low-pressure osmotic expansion in less than 60 minutes
- Demonstrated lasting patency
- Compatible with office-based procedures under local anesthetic
- Expandable technology for future ENT applications
Press release: SinuSys Receives CE Mark for AerOs™ Sinus DiIation System, Completes FDA 510(k) Submission
Product page: AerOs Sinus Dilation System…
