AventaMed, a Karl Storz company, received FDA 510(k) clearance for its Solo+ ear tube placement system. Solo+ combines multiple steps into an all-in-one device for a simplified approach to enable office-based pediatric tympanostomies. To date, ear tube placement typically takes place in an operating room and requires general anesthesia. The company designed the system to eliminate the need for general anesthesia, offering a quicker recovery and minimizing disruptions.
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With the single-use system, ear, nose and throat (ENT) specialists can place the ear tube in the patient’s eardrum with just the press of a button. By pressing the button while using as little as topical anesthesia, ENT specialists can perform these placements in alternative sites of care. AventaMed says its offering helps address unmet needs while improving the patient experience.
FDA clearance covers patients aged six months to 24 months old. Solo+ also attained certification for the European Medical Device Regulation (EU MDR) guidelines. AventaMed said it has preparations underway for a full global launch and expects a targeted rollout this year.
Karl Storz acquired Cork, Ireland-based AventaMed, the maker of the system, in 2023. The company spun out from Munster Technological University in 2015 and continues adding to Karl Storz’s extensive ENT portfolio.
“The Solo+ launch underpins our ambitious approach to continue to be the innovative partner of ENT surgery for state-of-the-art endoscopic treatments and to enable the different sites of care outside the operating theater to be offered more efficient solutions,” said Antonio Licata, executive director, upper endoscopy, Karl Storz.
