Medtronic has warned that one of the models in its Vanta range of implantable neurostimulators for pain relief may stop working if the patient is given cardioversion therapy to restore a normal heart rhythm.
The problem has been revealed in an urgent field safety notice for the product in Europe, which says that there have been two reports in which cardioversion damaged the electronics in the Model 977006 Vanta device, making it “unresponsive and non-functional.”
Medtronic’s Vanta devices are implanted in the epidural space between the vertebral canal and the spinal cord, where they emit electrical pulses to intercept and block pain signals in the nervous system before they can reach the brain.
In both cases cited in the field safety notice, the patients had to have the implants surgically removed and replaced in order to restore pain relief.
Medtronic points out that the manual for the Vanta unit does warn of the risk for damage to the device with cardioversion and recommends that the unit be temporarily reprogrammed during the procedure, which can help protect the device.
It also said that it has revised the manual and labeling for the device with recommended settings that can be used before a cardioversion procedure to reduce the risk of damage and updated patient documentation to make them aware of the issue.
First approved in 2021 to treat chronic pain caused by a range of conditions, Vanta was billed at launch as a major advance on other implantable neurostimulator devices thanks mainly to a battery life of up to 11 years depending on settings, while rival devices might need surgical replacement every two to five years.
It’s a sister product to Medtronic’s Intellis, which needs to be wirelessly recharged on a regular basis and competes in the market with other non-rechargeable spinal cord stimulation (SCS) devices like Abbott’s Proclaim Plus and Proclaim XR and Boston Scientific’s Alpha PC and Wavewriter Alpha.
Its closest rival is thought to be the Proclaim XR, which claims up to 10 years of battery power when programmed to its lowest doses.
Along with the long battery life, Vanta includes Medtronic’s AdaptiveStim technology that tracks the patient’s movement and body position with an internal accelerometer. This can adjust the intensity of stimulation based on whether they are lying down, sitting or standing up, which may shift the location of the spinal cord and its distance from the implant’s electrodes.
Users can also undergo full-body magnetic resonance imaging (MRI) while the device is implanted without fear of malfunction, according to Medtronic. It estimates that four out of five patients implanted with an SCS for pain relief will require at least one MRI scan within five years of beginning treatment with the device.
Labeling for the device was updated by the FDA last year to allow it to be used to treat pain associated with diabetic peripheral neuropathy, expanding the number of patients who may be eligible to use it.
All the implantable SCS therapies are, however, facing competition from DyAnsys’ recently approved First Relief system, which is adhered behind the ear and uses acupuncture-like needles to access the nervous system.