Medtronic has launched its Visualase MRI-Guided Laser Ablation System for neurosurgical procedures in Europe, following the CE-Mark approval.
The advanced system uses a specific applicator to deliver laser energy to the target region, where the temperature increases and leads to the destruction of unwanted soft tissue.
Said to be minimally invasive, the MRI guidance capability of the system facilitates accurate and controlled ablation during the surgery.
The US Food and Drug Administration (FDA) approved the Visualase system in July 2007.
Medtronic Brain Therapies division senior vice-president and president Brett Wall said: “The introduction of Visualase to European physicians ensures that more patients will have access to this beneficial technology.
“This latest milestone is a testament to our commitment to expanding therapeutic options for physicians and their patients.”
The company has also initiated a pivotal trial of its Symplicity Spyral renal denervation system to treat patients with high blood pressure (hypertension).
Renal denervation is performed to modulate the activity of nerves associated with the kidney, which is known to be involved in blood pressure management.
The multi-phased, randomised investigational device exemption (IDE) SPYRAL HTN trial is designed to evaluate the safety and efficacy of renal denervation in minimising hypertension without medication.
Set to recruit 433 patients at 50 centres across the US, Europe, Australia and Japan, the trial’s primary efficacy and safety endpoints are 24-hour blood pressure at three months and major adverse events incidence through one month following randomisation.