KARL STORZ’s AventaMed Earns FDA OK for Solo+ Ear Tube Placement Device

AventaMed, a KARL STORZ company, has earned U.S. Food and Drug Administration 510(k) clearance for its Solo+ ear-tube placement device.
 
Solo+ combines multiple steps into one device to allow a simplified approach for office-based tympanostomies. Ear-tube placement has usually been performed in the operating room, requiring general anesthesia for children who have chronic ear infections.
 
The single-use tympanostomy tube-placement system is placed in the eardrum by pressing a button, using small amounts of topical anesthesia. Solo+ aims to address unmet care needs by allowing ear-tube placement in alternative sites of care.
 
The FDA nod applies to patients aged six months to 24 months old. Solo+ also obtained EU MDR certification and a full global launch is in the works. The company said Solo+ will be available in select countries later this year.
 
AventaMed was created as a spinoff from Munster Technological University in 2015. KARL STORZ acquired the company last year and AventaMed enriched the already extensive ENT portfolio in the Tuttlingen, Germany-based, family-owned company’s arsenal.
 
“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, at KARL STORZ.