Medtronic plc announces 3-month results from an on-label, prospective, multi-center study showing meaningful pain relief using DTM SCS endurance therapy, a modified, lower-energy variation of the company’s Differential Target Multiplexed (DTM) Spinal Cord Stimulation (SCS) therapy for chronic overall, back or leg pain.
At 3 months, patients treated with DTM SCS endurance therapy reported meaningful pain relief as measured by a 3.9 cm reduction in overall pain on the 10 cm Visual Analog Scale (VAS). Patients also reported an average 4.3 cm decrease in back pain, and an average 5.0 cm decrease in leg pain.
The Visual Analog Scale (VAS) is a widely used and accepted measure for pain intensity that captures patient-reported pain levels on a scale of 0-10. These 3-month results are consistent with those of a prior feasibility study and add to the body of DTM SCS evidence demonstrating that DTM SCS endurance therapy can provide effective pain relief along with additional quality of life and functional benefits for patients.
Additional 3-month data include:
- 69% of patients improved to a less disabled category as measured by the Oswestry Disability Index, with 63% having minimal or moderate disability at 3-months compared to just 16% at baseline
- 75% of patients were very satisfied or somewhat satisfied with their therapy at 3-months
Modeling based on actual 3-month data also shows that DTM SCS endurance therapy enables between 5.5-7.5 years device longevity when programmed on the Vanta recharge-free neurostimulator. For those in need of a rechargeable device, DTM SCS endurance therapy programmed on the Intellis rechargeable neurostimulator allows either rapid recharge (5 minutes per day) or recharges of approximately one hour every 12 days.
“These 3-month results are highly encouraging, as they demonstrate that the DTM SCS endurance therapy may be able to provide effective pain relief while dosing at lower energy than other SCS waveforms. This may improve device longevity and offers validation of therapy for the patients who would need it.”— Dr. Kasra Amirdelfan, director of Clinical Research at IPM Medical Group Inc and principal investigator on the DTM-LE Trial
“Every patient with chronic pain has their own unique needs, and Medtronic is committed to offering solutions that personalize care for our patients. For many, especially those who need or prefer a recharge-free SCS solution, our new DTM SCS endurance therapy offers meaningful clinical benefits by reducing pain, improving quality of life, and offering meaningful device longevity.”— Charlie Covert, vice president and general manager, Pain Therapies within the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic
Enrolled patients will have additional follow-up assessments at 6 and 12 months.
[Source(s): Medtronicplc, PR Newswire]