Visualase reports success with pilot, phase I study

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Visualase, a developer of laser and image-guided technologies for minimally invasive thermal ablation, said that it has successfully enrolled and completed treatment of the first six patients in a pilot, phase I study demonstrating the safety of the Houston-based company’s Visualase MR-guided laser thermal ablation technique for the minimally invasive treatment of brain metastasis.

The study was conducted with the firm’s research partners, Houston-based BioTex and Paris-based Assistance Publique - Hôpitaux de Paris.

The treatment is performed under local anesthesia using an MR-compatible stereotactic frame and planning software to place a 1.6 millimeter diameter fiber optic laser applicator centrally inside the target tumor. The applicator delivers laser energy from a 15-watt 980-nm diode laser through a diffusing tip to heat the tumor tissue. During treatment, the patient is positioned in a 1.5-Tesla MRI while images are acquired continuously, the company said.

The Visualase computer workstation processes the MR images to provide real-time temperature maps and estimates of thermal damage around the applicator. The real-time damage predictions and safety points allow typical laser delivery to last less than 5 minutes. After treatment, patients immediately undergo additional MR imaging which allows post-treatment confirmation of the thermal ablation zone, according to Visualase.