Dalent Medical’s Sinusleeve balloon device completes FDA listing

Chloe Kent 7 August 2019 (Last Updated August 7th, 2019 11:58)

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.

Dalent Medical’s Sinusleeve balloon device completes FDA listing
Sinusleeve is a single-use, disposable BSD used for treating chronic sinusitis. Credit: Shutterstock

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.

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.”

Sinusleeve 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.”