Inspire Medical — Advancing Hypoglossal Nerve Stimulation Across LATAM

Inspire Medical Systems, a leading medtech company and FDA Breakthrough Device Designation recipient (2014, with expanded criteria in 2022), partnered with bioaccess® to expand clinical evidence for their Upper Airway Stimulation (UAS) system for obstructive sleep apnea in Latin American populations.

Study facts

• Sponsor / company: Inspire Medical
• Indication / area: Sleep Medicine / ENT
• Country: Brazil, Colombia
• Study type: Post-Market Clinical Follow-Up

Key metrics

• Countries: 2
• Regulatory Bodies: ANVISA, INVIMA
• Study Type: PMCF
• Outcome: Market access

The challenge

Inspire needed to generate real-world clinical data in Latin American patient populations to support regional regulatory submissions and market access strategies across multiple LATAM countries simultaneously.

bioaccess® solution

bioaccess® coordinated multi-country clinical sites in Brazil and Colombia, managing regulatory submissions to ANVISA and INVIMA, training local surgical teams on the implant procedure, and overseeing structured data collection aligned with Inspire's global clinical development program.

Results

• FDA Breakthrough Device Designation granted (2014; expanded criteria 2022) for Upper Airway Stimulation system
• Successful multi-country study execution across Brazil and Colombia
• ANVISA and INVIMA regulatory submissions managed end-to-end
• Local surgical teams trained and certified on the procedure
• Real-world evidence generated for LATAM market access
• Supported regional reimbursement and payer strategy discussions

Frequently asked

What did bioaccess® do for Inspire Medical?

bioaccess® coordinated multi-country clinical sites in Brazil and Colombia, managing regulatory submissions to ANVISA and INVIMA, training local surgical teams on the implant procedure, and overseeing structured data collection aligned with Inspire's global clinical development program.

Where was the Inspire Medical Post-Market Clinical Follow-Up study run?

The Inspire Medical Post-Market Clinical Follow-Up study was executed in Brazil, Colombia by bioaccess® in the sleep medicine / ent area.

What was the outcome of the Inspire Medical study?

Reported outcomes for Inspire Medical's device: FDA Breakthrough Device Designation granted (2014; expanded criteria 2022) for Upper Airway Stimulation system; Successful multi-country study execution across Brazil and Colombia; ANVISA and INVIMA regulatory submissions managed end-to-end.

Run a similar trial: Clinical trials in Brazil · Clinical trials in Colombia

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