US-based medical technology company Inspire Medical Systems has received the CE mark certification for its Inspire Therapy, under the EU’s Medical Device Regulation (EU MDR).
The new CE mark includes two significant updates to sleep apnea therapy, which were not previously certified under the EU directive 90/385/EEC.
It allows patients to undergo full-body MRI scans in a 1.5T MRI environment, subject to their adherence to the conditions specified in the Inspire MRI Guidelines Manual.
Also, the CE mark allows the current version of Inspire Therapy’s leads with silicone insulation.
The medical technology company said that its Inspire Therapy is the first and only FDA-approved technology to treat advanced obstructive sleep apnea (OSA).
Inspire chairman and president Tim Herbert said: “Inspire has a long history of compliance to the European Union’s (EU) quality system and CE mark requirements, with uninterrupted CE mark approval since 2010.
“The Inspire team has worked diligently with our notified body in Europe to complete the review process, which included obtaining temporary approval through derogation authorisation to continue to deliver Inspire products in several countries.”
Inspire Medical said that, unlike other OSA therapies, its Inspire implant works comfortably inside a patient’s body to help keep their airway open while they are asleep.
The treatment involves an airway exam to confirm whether the Inspire implant works for a patient or not, where the doctor will use a tiny camera to look inside the patient’s airway.
After the airway exam, which requires around 20 minutes, a small Inspire implant is placed near your collarbone through a 90-minute outpatient procedure.
The patients will get their Inspire remote and learn how to use it during a follow-up appointment with their doctor, who will guide the patients through a step-up plan.
The step-up plan allows patients to develop a routine of turning on their devices and guides them to the appropriate therapy level, said the medical technology company.
Inspire Medical Systems Europe managing director and executive vice president Andreas Henke said: “In 2017 the European Parliament enacted a new regulatory framework (i.e., EU MDR 2017/745) for the certification of medical devices in the EU.
“As a result, the entire medical device industry must repeat the process for both design and quality system certification to the new, more stringent, requirements.
“The scale of this transition to a new regulatory framework has proven to be a challenge for medical device manufacturers and the notified bodies who certify them.”
