AventaMed, a Cork-based medical device start-up which is set to revolutionise paediatric ear, nose and throat surgery has beaten 26 global organizations in a major medical device bid.
The pioneering company will be one of 12 Real-World Evidence Test-Cases selected by The National Evaluation System for Health Technology Coordinating Center (NESTcc) to evaluate the use of real-world evidence (RWE) in medical device regulatory processes.
AventaMed is the first and only Irish company to make the coveted list and will be in the company of well-known medical device manufacturers such as Abbott Diagnostics and Medtronic, as well as the U.S. Food and Drug Administration (FDA). AventaMed’s project will focus on Pediatric Clinical and Health Services Outcomes following Ear tube (grommet) insertion.
NESTcc test cases will help to create a database of real-world evidence which will aim to improve product safety and regulatory decision making across the product lifecycle. NESTcc recognises the need to improve patients’ timely access to the latest medical technology as well as to improve the quality of life for patients with medical devices.
Commercial health care datasets and registries are often not publicly available or prohibitively expensive for small medtech companies. It can be particularly difficult for companies based outside the USA to understand where and how to access this information.
AventaMed offers an alternative solution to traditional ear tube surgery which is currently performed under general anaesthesia in hospital theatres. AventaMed’s innovative product, the Solo Tympanostomy Tube Device (Solo TTD), enables the quick and simple insertion of ear tubes without general anaesthesia. The procedure is less invasive, faster and safe, offering parents a new option.
Olive O’Driscoll, Chief Executive of AventaMed, said, “It is a great honour to be selected, as the only Irish company and we are very proud to be recognised and positioned alongside leaders in the medtech arena. This is a unique opportunity for a small start up to collaborate with renowned experts at leading healthcare organisations in the USA. We will gain a deep understanding of the clinical and economic outcomes of ear tube surgery, which accounts for almost 1 million surgical procedures every year in the USA. Working in collaboration with PEDSnet and Healthcore, will enable us to acquire and investigate this data which would not ordinarily be available to medical device companies to inform our strategic and commercial decisions as we enter this important new market.”