Abbott touts benefits of non-rechargeable SCS devices
Abbott released analysis data from a study of its non-rechargeable spinal cord stimulation devices, touting low rate of explants for the devices.
The study examined real-world clinical data from 956 SCS systems implanted between 2010 and 2013, collected at 4 implanting centers in Europe. Researchers in the study tracked implants, follow-up visits and explants of systems through mid-2016.
Data from the analysis indicated that patients with 10kHz high-frequency rechargeable devices experienced the highest percentage of explants for inadequate pain relief at 14.1%, followed by traditional tonic or frequency rechargeable devices at 11.9%. Recharge-free tonic stimulation devices reported the lowest rate of explants at 6.9%
A total of 463 patients in the review received tonic non-rechargeable devices, while 328 patients received traditional tonic stim rechargeable devices and 154 received 10kHz high-frequency devices.
There were 178 unanticipated explants in the review, with more than half due to inadequate pain relief. Patients with 10 kHz high-frequency devices had a 76% greater risk of explant than those equipped with recharge-free devices, Abbott reported.
The company said it has “made recharge-free SCS systems a priority,” though currently it only offers the Proclaim Elite SCS system.
“Physicians today have multiple options to deliver spinal cord stimulation therapy to patients, and clinical evidence has established the safety and effectiveness of the therapy for many types of chronic pain. Yet as the options expand, we must validate clinical trial results with real-world data that confirm which devices provide strong, durable results for different indications and which are potentially subjecting patients to higher rates of explantation for inadequate pain relief,” study lead author Dr. Jean-Pierre Van Buyten of St. Niklaas, Belgium’s AZ Nikolaas said in prepared remarks.
“Real world clinical data is critical to helping physicians evaluate the therapies they’re offering their patients and to gain insight into the therapies that may subject their patients to risks related to inadequate pain relief. This study helps fill a gap in needed long-term outcome data and affirm the merits of primary cell, recharge-free devices that help physicians choose the right device for the right patient,” Abbott neuromod medical director Dr. Burton said in a press release.