The Sinusleeve Balloon is a single-use, disposable, balloon sinus dilation device (BSD) used for treating chronic sinusitis
Image: Dalent Medical secures FDA listing for Sinusleeve Balloon Device Photo: Courtesy of James Heilman/Wikipedia.org.
Dalent Medical, a Miami-based company developing innovative devices for Ear, Nose & Throat Doctors is pleased to announce that the Sinusleeve Balloon Sinus Dilation Sleeve has completed the United States Food and Drug Administration’s listing process. The company will begin selling the Sinusleeve balloon device in their home state of Florida to Otolaryngologists immediately.
The Sinusleeve Balloon is a single-use, disposable, balloon sinus dilation device (BSD) used for treating chronic sinusitis. Developed and manufactured in the United States, this patented device fits over rigid, flexible and reusable positioning and suction devices by way of a conforming sleeve. The Sinusleeve Balloon accommodates 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. 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,” said CMO Dr. Agustin Arrieta.
Over 12 million people visit their doctor for symptoms related to Chronic Sinusitis each year and surgeries are on the rise. According to Dr. Arrieta, “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 is in the process of onboarding key hires to start building and managing sales relationships starting in Florida. “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 doctor’s hands. Now that the device is FDA listed, we will shift our focus to marketing and sales,” stated CEO, Shawn McCoy.
The Sinusleeve Balloon is expected to be available across the nation in 2020.
Source: Company Press Release