APPROVED! BrainPortV100 to help the blind process visual signals via their tongues (Wicab, Inc., Middleton, WI, Approved 6/18/15)
Non-surgical assistive device for blind with no useful vision. Translates digital information from a video camera into gentle electrical stimulation patterns on the surface of the tongue. Users feel moving bubble-like patterns on their tongue which they learn to interpret as the shape, size, location and motion of objects in their environment.
- CDRH De novo premarket review pathway : Low- to moderate-risk medical devices, not substantially equivalent to an already legally-marketed device
- Effectiveness Assessment : Object recognition and word identification, oral health exams to. Studies showed that 69 percent of the 74 subjects who completed one year of training with the device were successful at the object recognition test.
- Safety Assessment: Risks associated with holding the intra-oral device in the mouth. Reports of burning, stinging or metallic taste, no serious device-related adverse events.
FDA Summary of Safety and Effectiveness Data and Labeling POSTED!
Misago Peripheral Stent System – P140002 (Terumo Medical Corporation, Elkton, MD, Tokyo, Japan, Approved 5/22/15)
The Misago Peripheral Stent System is used to re-open narrowed regions of an artery that supplies blood to the leg. Consists of : Stent and Delivery System. Stent is a small nickel and titanium alloy tube, mounted within the long, thin, tube delivery catheter to deliver the stent into the artery.
- CDRH Premarket Approval Appliction (PMA) : US and ex-US clinical studies to establish reasonable assurance of safety and effectiveness of stenting
- Effectiveness Assessment : Primary Effectiveness endpoint (stent patency of 66% at 12 months – NOT met). FDA considered Sponsor’s analysis ‘overly conservative’! Analysis conforming to FDA guidance using Kaplan-Meier method (time-to-event format with appropriate censoring); freedom from loss of patency at 12 months was 78.9%
- Safety Assessment: Freedom from major adverse events (MAE) at 30 days post-procedure >99%
- Benefit/Risk Assessment : Approved even though Sponsor -Defined Endpoint not met. Approval based on FDA analysis for precedents and differentiation from other approved devices (high unmet need, Quality of Life improvement, risk minimization by safe and effective device use, Commitment for Extended Follow-Up Study: