Medtronic obtains Food and Drug Administration approval for Visualase V2 MRI-directed laser destruction system
In recent developments, Medtronic, a leading global healthcare solutions company, has secured multiple U.S. Food and Drug Administration (FDA) approvals for its neuromodulation devices, expanding treatment options for patients with Parkinson's disease and hypertension.
The most significant approval came in August 2024, with the landmark FDA approval of the Asleep Deep Brain Stimulation (DBS) surgery. This approval marks the first-ever FDA approval for such a procedure and offers more personalized treatment options for those suffering from Parkinson’s disease. The new MRI labeling extends active scan times for Medtronic DBS systems, providing greater flexibility in patient care [2].
Another noteworthy FDA-approved device by Medtronic is the Symplicity Spyral Renal Denervation (RDN) system, which received approval prior to July 2025. This system delivers radiofrequency energy to renal arteries for the treatment of hypertension, and Medtronic continues to innovate in this field with next-generation catheter designs aimed at safer, minimally invasive wrist-based access procedures [1].
The ZEISS MEL 90 excimer laser, while not a neuromodulation device by Medtronic, has also received U.S. FDA approval for an unspecified purpose.
Meanwhile, Medtronic's Visualase V2 MRI-Guided Laser Ablation System has received 510(k) clearance from the U.S. FDA. This system, designed for use in patients with focal epilepsy, brain tumors, and radiation necrosis, offers a minimally invasive surgical option. Compared to traditional open neurosurgery, the Visualase system provides benefits such as reduced hospital stays, faster recovery, minimal scarring, lower risk of infection, and high patient satisfaction [3].
The Visualase system uses laser interstitial thermal therapy (LITT) to deliver precisely targeted energy, allowing surgeons to navigate deep within the brain with pinpoint accuracy. The V2 offers proven precision, accuracy, and enhanced visualization capabilities [3]. Notably, the focus of NeuroOne's FDA timeline acceleration is on nerve ablation systems, with the V2 being a prime example [4].
In a significant breakthrough, Medtronic has also earned U.S. FDA approval for the world's first adaptive deep brain stimulation system, specifically designed for people with Parkinson's disease [5]. This system, designed for use in patients with Parkinson's, is adaptive in nature, offering a more personalized approach to treatment.
Sources: [1] Medtronic. (n.d.). Symplicity Spyral Renal Denervation System. Retrieved from https://www.medtronic.com/uk-en/healthcare-professionals/therapies/symplicity-spyral-renal-denervation
[2] Medtronic. (n.d.). Asleep Deep Brain Stimulation. Retrieved from https://www.medtronic.com/uk-en/healthcare-professionals/therapies/deep-brain-stimulation/asleep-deep-brain-stimulation
[3] Medtronic. (n.d.). Visualase MRI-Guided Laser Ablation System. Retrieved from https://www.medtronic.com/uk-en/healthcare-professionals/therapies/visualase-mri-guided-laser-ablation-system
[4] Medtronic. (n.d.). NeuroOne Medical Technologies Corporation. Retrieved from https://www.medtronic.com/uk-en/about/news/press-releases/2022/08/medtronic-announces-acquisition-of-neuroone-medical-technologies-corporation.html
[5] Medtronic. (n.d.). Medtronic Earns FDA Approval for World's First Adaptive Deep Brain Stimulation System for People with Parkinson's Disease. Retrieved from https://www.medtronic.com/uk-en/about/news/press-releases/2024/08/medtronic-earns-fda-approval-for-worlds-first-adaptive-deep-brain-stimulation-system-for-people-with-parkinsons-disease.html
Digital health advancements in science continue as Medtronic's Visualase V2 MRI-Guided Laser Ablation System, approved by the FDA, offers a minimally invasive surgical option for health-and-wellness management in patients with focal epilepsy, brain tumors, and radiation necrosis. Additionally, Medtronic's foray into the field of medical-conditions extends with the FDA approval of their groundbreaking adaptive deep brain stimulation system, providing a more personalized treatment approach for people suffering from Parkinson's disease.
