"We made it our mission to secure expanded MRI labeling for our spinal cord stimulation devices – both those that were already implanted and those still to be implanted – for the sake of the patients and their doctors." Burton, MD, medical director of Abbott's neuromodulation business. They are particularly important for patients who have certain comorbidities, such as cancer or multiple sclerosis," said Allen W. "MRIs have increasingly become an important tool helping doctors diagnose an illness or injury. Under the expanded MRI labeling, patients with a Proclaim XR SCS device can benefit from higher quality images with faster MRI scan times. The new labeling lifts MRI restrictions for lead tip location and the amount of radiofrequency power that can be used as part of the normal operating mode of an MRI scan, covering the majority of Proclaim XR patients. “This FDA expanded indication approval for our SCS devices is a significant step forward in Abbott’s goal to provide treatment access to those who suffer daily with chronic back pain but are not eligible for corrective surgery,” said Pedro Malha, vice president, neuromodulation, Abbott.The US Food and Drug Administration (FDA) has approved new expanded MRI compatibility for Abbott’s Proclaim XR Spinal Cord Stimulation (SCS) System with Octrode leads. On average, those who received SCS therapy experienced a 69.7% reduction in pain. That compares to just 7.1% in the conservative medical management arm.Ībbott said 91.4% of people who received SCS therapy obtained significant pain relief or significantly improved function. Additionally, 72.6% of people in the SCS study arm and 85.2% of those implanted achieved significant back pain reduction. That remained the case at the 12-month follow-up. Results at six months for the first 200 patients demonstrated clear clinical evidence supporting BurstDR as an effective treatment. According to Abbott, it marks the largest randomized controlled trial in the non-surgical back pain population. The DISTINCT study enrolled 270 patients who suffered with pain for an average of 12.8 years. Abbott said 70.8% of subjects with chronic pain preferred BurstDR. Previous studies showed comfortability with BurstDR, with patients preferring it to traditional tingling tonic stimulation. It achieves this without an abnormal sensation of tingling (paresthesia) to change pain signals traveling from the spine to the brian. About the Abbott BurstDR and the DISTINCT studyīurstDR, a form of stimulation therapy, delivers pulses of mild electrical energy. SCS therapies feature its proprietary, low-energy BurstDR waveform. Eterna received expanded FDA indications last week.Īll of Abbott’s U.S. That includes the recharge-free Proclaim SCS family and the rechargeable Eterna SCS platform. The company said the new indication spans the entirety of its SCS portfolio in the U.S. “This new indication for Abbott’s SCS devices, together with BurstDR stimulation, allows physicians the ability to identify and treat a new group of people, providing them with relief from chronic back pain.” Timothy Deer, president and CEO of the Spine and Nerve Centers of the Virginias in Charleston, West Virginia. “To date, we have struggled with how to treat people who weren’t considered a good surgical candidate because we didn’t have clear, data-driven treatment options for non-surgical back pain,” said Dr. It also showed enhanced ability to perform daily activities and emotional well-being in people with chronic back pain. The study demonstrated improved pain levels with Abbott’s proprietary BurstDR SCS technology. Results from Abbott’s DISTINCT study supported the labeling expansion, according to a news release. This is also known as non-surgical back pain. The FDA approval applies to the treatment of chronic back pain in those who have not had or are not eligible to receive back surgery. The Eterna spinal cord stimulation (SCS) system Abbott (NYSE:ABT) announced today that it received FDA approval for the use of its spinal cord stimulation devices (SCS) for certain people with back pain.
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