Medtronic plc received FDA premarket approval Friday for use of its Intellis rechargeable and Vanta recharge-free neurostimulators in patients with diabetic peripheral neuropathy (DPN), suddenly tripling the number of spinal cord stimulators approved for the indication. Medtronic’s implantable spinal cord stimulators (SCS) now join Nevro Corp.’s HFX, which has had the distinction since July 2021 of being the only device with FDA approval for DPN, also known as painful diabetic neuropathy (PDN).

Medtronic plc released initial results showing meaningful pain relief using differential target multiplexed (DTM) spinal cord stimulation (SCS) endurance therapy, a lower-energy form of its DTM SCS treatment for overall, back or leg pain. At three months, patients in the on-label, prospective, multicenter study reported that their overall pain was about half what it was at the start of the study, measured by a 3.9 cm reduction on the 10 cm Visual Analog Scale (VAS) vs. 7.8 cm at baseline. Patients in the study also reported an average decrease in back and leg pain or 4.3 cm and 5.0 cm, respectively. Medtronic plans to offer the DTM SCS endurance therapy on its rechargeable Intellis and primary cell Vanta platforms.

Medtronic plc is looking to increase market share in pain stimulation with its differential target multiplexed (DTM) therapy, a recharge-free device and its next big disrupter, evoked compound action potential (ECAP). The company is currently developing a closed-loop SCS system for chronic pain following failed back surgery based on ECAP and DTM algorithms.

Medtronic plc reported 12-month data from a large, multicenter, randomized controlled clinical trial affirming the superiority of differential target multiplexed spinal cord stimulation (DTM SCS) in relieving chronic back pain, vs. traditional SCS therapy, using its Intellis platform.