AventaMed, a KARL STORZ Company, Gains FDA Clearance for Solo+™ Ear-Tube Placement Device
06 Agosto 2024 - 9:55AM
Business Wire
Chronic ear infections are a leading reason for doctor visits
and surgical procedures such as placement of ear tubes in young
children.1-3 Ear-tube placement has typically been performed in an
operating room, requiring general anesthesia for children.
Introducing Solo+, a revolutionary advancement in pediatric care
that emphasizes safety, overall patient satisfaction, and
healthcare efficiency. Solo+ combines multiple steps into an
all-in-one device, facilitating a simplified approach to enable
office-based pediatric tympanostomies. Designed to eliminate the
need for general anesthesia, single-pass devices, like the Solo+,
significantly reduce the risks and side effects associated with
general anesthesia during traditional tympanostomy tube insertion,
offering a quicker recovery and minimizing disruption for young
patients and their families.4-7 Its ease of use and the
comprehensive support system provided by KARL STORZ ensures a
smooth transition for office staff, fostering an environment of
excellence and innovation in patient care. For insurance payors,
Solo+ represents a cost-effective solution that streamlines care
delivery, improves access, and aligns with market trends toward
minimally invasive procedures.4,8,9
The US Food and Drug Administration (FDA) has given 510(k)
clearance to the product for patients aged 6 months to 24 months
old. In addition, Solo+ has attained certification in fulfilling
the requirements of the European Medical Device Regulation (MDR). A
full global launch is in preparation, and Solo+ will be available
in targeted countries this year.
Ear-Tube Placement at the Press of a Button with
Solo+
Otitis media may result in accumulation of fluid within the
tympanic cavity, which can be painful and lead to a decrease in the
ability to hear.3 Children are more prone to this condition.10
Persistent hearing loss may negatively influence language
development, behavior, and progress in school.11 When symptoms
persist or worsen, tympanostomy tube (ear tube) insertion may be
recommended. By the age of three, nearly 1 in every 15 children
will have had ear tubes.3 With the innovative, single-use
tympanostomy tube-placement system Solo+, Ear, Nose and Throat
(ENT) specialists have the option to place the ear tube in the
patient's eardrum by pressing a button using as little as topical
anesthesia in alternative sites of care. The achievement of MDR
certification and FDA 510(k) clearance reflects our commitment to
innovating medical device solutions that address unmet needs to
improve the patient experience.
ENT Product Portfolio Grows
AventaMed, the KARL STORZ company that developed Solo+, was
created as a spinoff from Munster Technological University in 2015.
It was acquired by KARL STORZ in January 2023 and has since
enriched the already extensive ENT product portfolio of the
family-owned MedTech company headquartered in Tuttlingen, Germany.
“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.
1 Ahmed S et al. Incremental health care utilization and costs
for acute otitis media in children. Laryngoscope.
2014;124(1):301-5. doi: 10.1002/lary.24190. 2 Bhattacharyya N, Shay
SG. Epidemiology of Pediatric Tympanostomy Tube Placement in the
United States. Otolaryngol Head Neck Surg. 2020;163(3):600-602.
doi: 10.1177/0194599820917397. 3 Rosenfeld RM et al. Clinical
Practice Guideline: Tympanostomy Tubes in Children.
Otolaryngology–Head and Neck Surgery. 2013;149:S1-S35. doi:
10.1177/0194599813487302. 4 Billings KR et al. Single Visit
Evaluation and Tympanostomy Tube Placement for the Treatment of
Acute Otitis Media in Children. Laryngoscope.
2021;131(12):2823-2829. doi: 10.1002/lary.29714. 5 Fournier I et
al. Comparison of Tympanostomy Tubes Under Local Anesthesia Versus
General Anesthesia for Children. Laryngoscope. 2023.
doi:10.1002/lary.31095. 6 Davidson J et al. Cost and efficiency of
myringotomy procedures in minor procedure rooms compared to
operating rooms. Laryngoscope. 2020;130(1):242-246. doi:
10.1002/lary.27840. 7 Lustig LR et al. In-Office Tympanostomy Tube
Placement in Children Using Iontophoresis and Automated Tube
Delivery. Laryngoscope. 2020. doi: 10.1002/lary.28612. 8 Brodsky L
et al. Office-Based Insertion of Pressure Equalization Tubes: The
Role of Laser-Assisted Tympanic Membrane Fenestration.
Laryngoscope. 1999;109(12):2009-2014. doi:
10.1097/00005537-199912000-00022. 9 Roy CF et al. Procedural
Sedation in Minor Procedure Rooms for Pediatric Myringotomy and
Tympanostomy: A Quality Improvement Initiative. Otolaryngol Head
Neck Surg. 2022;167(6):979-984. doi: 10.1177/01945998211011066. 10
Bluestone CD, Swarts JD. Human evolutionary history: consequences
for the pathogenesis of otitis media. Otolaryngol Head Neck Surg.
2010;143(6):739-44. doi: 10.1016/j.otohns.2010.08.015. 11 Jamal A
et al. Effect of Ear Infections on Hearing Ability: A Narrative
Review on the Complications of Otitis Media. Cureus.
2022;14(7):e27400. doi: 10.7759/cureus.27400.
About KARL STORZ
The medical technology company KARL STORZ was founded in 1945 in
Tuttlingen, Germany, and is one of the leading international
suppliers in the world of endoscopy. Now in its third generation,
the family-owned company employs 9,400 people in more than 40
countries worldwide. The portfolio comprises around 13,000 products
for human and veterinary medicine. KARL STORZ stands for visionary
design, precision craftsmanship, clinical effectiveness, and
outstanding customer service. Research, development, and production
sites are located in Germany, USA, Switzerland, and Estonia. For
more information, visit www.karlstorz.com
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Susan Mancia Mobile: 562-841-1515 E-mail:
susan.mancia@karlstorz.com