Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

Dalent Medical readying to launch Sinusleeve device

August 12, 2019 By Nancy Crotti

The Sinusleeve balloon sinus dilation sleeve. (Image from Dalent Medical)

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.”

Related Articles Read More >

A cylindrical-shaped medical device with a blue cap on one end and a brown cap on the other
How SeaStar’s device calms hyperinflammation — and could prevent lasting damage from COVID cytokine storms
A phlebotomist draws blood from a patient in her home
How to leverage technology to drive diversity in clinical studies
A portrait of Finnegan attorney Marcelo Barros
Medical device licensing pitfalls to avoid
Miniature device components next to a dime coin for scale
Tolerance stack-up: Insight into the inner workings of high-density microelectronic medical devices

DeviceTalks Weekly.

June 24, 2022
How innovative design, commercial strategy is building Cala Trio’s bioelectronic medicine market
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech