Medtronic’s FDA approval of closed-loop SCS device,Inceptiv to increase standing in market: GlobalData

While this is not the first closed-loop SCS device to gain approval as Saluda Medical received FDA approval in 2022, it is the first of the larger players in the market to gain approval.

The FDA approval of Medtronic‘s closed-loop spinal cord stimulation (SCS) device “Inceptiv” marks a significant milestone in the SCS market. Medtronic’s entry into closed-loop technology presents opportunities for market expansion, which was worth $2.2 billion in 2023 and is expected to reach $4.3 billion in 2033, according to GlobalData

While this is not the first closed-loop SCS device to gain approval as Saluda Medical received FDA approval in 2022, it is the first of the larger players in the market to gain approval. This gives Medtronic an advantage in potentially expanding its market share since it is expected for the market to gradually transition towards closed-loop devices.

Medtronic currently covers approximately 29 per cent of the rechargeable SCS market with its competitors, Nevro, Boston Scientific and Abbott making up 25 per cent, 24 per cent and 13 per cent of the market respectively.

Aidan Robertson, Medical Analyst at GlobalData, comments, “Medtronic has gotten a leg up on its major competitors when it comes to developing this new technology in the SCS market. This will likely have a positive impact on its standing in this market as the advantages of a closed-loop device versus open-loop are certain to garner interest.”

The value of using closed-loop SCS devices compared to open-loop is the ability to adjust the stimulation output. Open-loop SCS devices have a set amount of stimulation given when physicians first program the product. This approach can result in overstimulation that may be uncomfortable for patients. Closed-loop devices can adjust their output in real time in response to signals in the body by adapting to various body movements being performed thus providing more customised care.

The spinal cord stimulation market is expected to grow as the increasing geriatric population will continue to drive the demand for SCS devices that help with a whole host of chronic pain conditions. Eventually, more advanced and versatile technologies such as closed-loop SCS will be increasingly appealing to patient populations and a shift towards these products is anticipated in the future.

Robertson concludes, “With Medtronic leading the way for closed-loop SCS devices GlobalData expects a legitimate sales boost in this market after the launch of Inceptiv.”