Abbott Receives FDA Approval to Expand MRI Labeling for Proclaim DRG Neurostimulation System, Enabling Full-Body MRI Scans

Feb 05, 2024 18:38 CST Updated 18:38

Abbott

Diagnostic and pharmaceutical product manufacturers

January 18, 2024, Global Healthcare CompanyAbbott (Abbott)Announced that the U.S. Food and Drug Administration (FDA) has approved the company'sDorsal Root Ganglion (DRG) Stimulation Therapy — "Proclaim DRG Neurostimulation System"Extended magnetic resonance imaging (MRI) labeling allows patients to undergo whole-body MRI scans with the system implanted.

Proclaim DRG Neurostimulation System is the only FDA-approved DRG technology currently available., which can stimulate the DRG nerve cell clusters distributed along the spine, for Type I and Type II of the lower limbsComplex Regional Pain Syndrome (CRPS)Provide targeted relief for patients. CRPS is a rare and painful condition, andThe Proclaim DRG System is an effective treatment option for CRPS; four out of five patients who received this therapy experienced significant pain relief and improved quality of life.

The Proclaim DRG system, due to the placement of its stimulating electrodes, achieves low-energy consumption and therapeutic effects without paresthesia. The system's proprietary delivery mechanism and unique surgical approach enable precise anatomical targeting of the DRG.

After the MRI labeling extension for the Proclaim DRG system, both new and existing patients will be able to undergo full-body MRI scans while using the system, achieving flexibility in short- and long-term imaging needs.Doctors and patients can also find suitable medical imaging centers more easily and directly.

Dr. Timothy Deer, Chairman and Chief Executive Officer of Virginia Spine and Neurological Center, USASaid, "Ability to undergo full-body MRI scans while using the Proclaim DRG system, which means that as doctors, we can ensure patients receive the necessary treatment in a timely manner, as they no longer need to specifically seek facilities equipped with special MRI setups compatible with the Proclaim DRG system. After expanding the MRI label for this system,We no longer need to sacrifice superior pain relief and quality of life outcomes to meet the demands of MRI.”

Pedro Malha, Vice President of Abbott's Neuromodulation BusinessSaid, "We have been fully committed to the treatment of chronic pain. Therefore, we are pleased to see that our proprietary and unique DRG stimulation therapy can expand MRI labeling. This has become a valuable tool that enables doctors to help patients return to a comfortable life.”

About Abbott

Abbott (https://www.abbott.com/) delivers groundbreaking innovations in diagnostics, medical devices, nutrition, and pharmaceuticals, bringing health to people and communities and making life full of possibilities. From eliminating the common finger pain associated with diabetes to connecting patients and doctors through real-time cardiac monitoring, from alleviating chronic pain and movement disorders to screening over half of the world's donated blood supply for safety, Abbott’s mission is to bring life-changing health technologies to those in need and make the world a better place. Today, Abbott’s 115,000 employees worldwide help people in more than 160 countries and regions live healthier and fuller lives.

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