Dalent Medical said last week that it has listed its Sinusleeve balloon sinus dilation device with the FDA.
Sinusleeve is a single-use, disposable device used for treating chronic sinusitis, according to the Miami-based company. Sinusleeve is an FDA 510(k)-exempt Class 1 device that the company said it will begin marketing immediately to otolaryngologists in Florida.
The patented device fits over rigid, flexible and reusable positioning and suction devices by way of a conforming sleeve. It can accommodate instrumentation of varying sizes and curves, allowing access, simultaneous suction and balloon dilation all in one.
“The Sinusleeve balloon was developed by ENTs for ENTs,” said Dalent Medical chief medical officer Dr. Agustin Arrieta in a news release. “Previously, we needed more devices on-hand to execute sinus dilation procedures. Now with a more versatile sleeve, surgeons can streamline costs without limiting their instrument options. 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.”
Dalent Medical said it is building and managing sales relationships starting in Florida and expects Sinusleeve to be available across the nation in 2020.
“Our team has spent years testing and improving this device with help from our ENT advisors and investors,” said company CEO Shawn McCoy. “I’m confident we developed a great device and we’re excited to get it into doctor’s hands. Now that the device is FDA-listed, we will shift our focus to marketing and sales.”