Medtronic Receives FDA Approval for Visualase™ V2 MRI-Guided Laser Ablation System

Medtronic Announces the Latest GenerationMagnetic Resonance-guided Laser Ablation System---Visualase V2Approved by the FDA for marketing. Medtronic believesVisualase V2It is a significant breakthrough, offering a new minimally invasive surgical option for more than 1 million patients worldwide with focal epilepsy, brain tumors, and radiation necrosis.

Executive Evaluation

"This approval is a dual blessing for patients and clinicians, as real-time MRI-guided minimally invasive procedures elevate surgical precision to new heights, marking a significant advancement in the field of neurosurgery."

---Ashwini Sharan  Chief Medical Officer of the Neuromodulation Division under Medtronic's Neuroscience Business

Medtronic's Previous GenerationMagnetic Resonance-guided Laser Ablation SystemVisualase is a revolutionary product.The emergence of VisualaseDoctors can ablate diseased brain tissue through a microcatheter under real-time MRI guidance.While protecting the surrounding nerve structures,Provides a less invasive alternative to traditional craniotomy neurosurgery.

VisualaseUsing Laser Interstitial Thermal Therapy (LITT), precise energy delivery is performed via a micro-catheter under real-time MRI guidance. Compared to traditional craniotomy, Visualase offers five clinical advantages:

• Minimally Invasive Intervention: Only a 4mm Incision Required

• Shorten Hospital Stay, Accelerate Recovery Process

• Minimization of Wound Scars

• Significantly Reduce the Risk of Infection

• Patient satisfaction rate as high as 94%

Visualase V2PhaseCompared to the previous generation productVisualase, while maintainingBuilding on the mature and stable precision, accuracy, and superior imaging capabilities, the system offers a complete upgrade of hardware, software, and the user interface to enable a more intuitive and efficient surgical workflow. Its forward-thinking design supports future iterations of LITT technology innovation, expanding treatment boundaries without the need for hardware replacement.

Medtronic, founded in 1949 and headquartered in Minneapolis, Minnesota, USA, is a global leader in medical technology dedicated to providing lifelong treatment solutions for patients with chronic diseases. Medtronic's main products cover areas such as arrhythmia, heart failure, vascular diseases, heart valve replacement, extracorporeal heart support, minimally invasive cardiac surgery, malignant and non-malignant pain, movement disorders, diabetes, gastrointestinal diseases, urological conditions, spinal disorders, neurological diseases, and ENT surgical treatments.