Medtronic has secured approval from the US FDA for its Intellis rechargeable neurostimulator and Vanta recharge-free neurostimulator to treat chronic pain associated with diabetic peripheral neuropathy (DPN).
DPN is a debilitating and progressive neurological disorder, which affects around 30% of people with diabetes.
The new indication provides patients with DPN access to the company’s spinal cord stimulation (SCS) portfolio of rechargeable and recharge-free platforms, including various programming options to personalise patient therapy.
The options also include unrestricted MRI access, improved battery chemistry and performance, as well as the Medtronic TYRX neuro absorbable antibacterial envelope.
According to the company, the TYRX antibacterial surgical mesh envelope has been demonstrated to stabilise device placement and minimise infection by more than 60%.
Clinicians can also suggest patients to take support of CareGuidePro, which acts as a virtual guide for patients across their SCS journey, the company said.
Medtronic also stated that independent studies demonstrate that treatment with SCS for patients with DPN has resulted in significant pain relief, compared to conventional treatments alone.
In addition, in one of the studies, a long-term analysis of the treatment of patients using the company’s SCS technology demonstrated 80% of patients treated with SCS carried on using their devices at five years to treat pain.
Medtronic neuroscience portfolio’s neuromodulation business’ pain therapies general manager and vice president Charlie Covert said: “DPN is a significant challenge for patients with diabetes, leading to disability and a diminished quality of life.
“This new indication enables us to apply Medtronic’s more than 40 years of proven SCS experience, as well as the company’s deep diabetes expertise, to deliver better care to even greater numbers of diabetes patients.”
In December last year, Medtronic received 510(k) clearance from the US FDA for paediatric indications of the Invos 7100 cerebral/somatic oximetry system.
