Miami-based ear, nose and throat device company Dalent Medical has announced the commercial release of the Sinusleeve, a balloon sinus dilation device (BSD), following its completion of the US Food and Drug Administration (FDA) listing process.
The device is now being sold to Florida otolaryngologists.
Go deeper with GlobalData
Sinusleeve is a single-use, disposable BSD used for treating chronic sinusitis. The device can fit over rigid, flexible and reusable positioning and suctioning devices for balloon sinuplasty surgeries, carrying out simultaneous suction and dilation. It accommodates instruments of varying sizes and curves and its long inflation tube provides positioning options by adapting its reach to a variety of instruments. This allows the surgeon to gain access to hard-to-reach blocked sinuses.
During a balloon sinuplasty, the Sinusleeve will be dilated within the patient’s nasal cavity, opening up closed or blocked sinuses to provide relief from the associated chronic pain. When the device is removed from the patient the sinus remains open, with an enlarged ostium to allow trapped fluid to drain.
Over 12 million patients visit their doctor for symptoms related to chronic sinusitis each year in the US, and sinuplasties are on the rise.
Dalent Medical chief medical officer Dr Agustin Arrieta said: “Patients are asking for balloon dilation procedures because they can go in for a procedure one afternoon and go to work the next day relieved of sinus symptoms that have nagged them for years. Less invasive devices like the ones we’re developing are driving the steady growth of surgeries in this category.”
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataSinusleeve is expected to be available nationwide by 2020.
Dalent Medical CEO Shawn McCoy said: “Our team has spent years testing and improving this device with help from our ENT advisors and investors. I’m confident we developed a great device and we’re excited to get it into doctors’ hands. Now that the device is FDA-listed, we will shift our focus to marketing and sales.”
