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BSD Medical receives 510(k) clearance for new microwave ablation system

BSD Medical : 11 September, 2008  (New Product)
The US FDA has granted BSD Medical a 510(k) clearance to market the company’s MicroThermX-100 Microwave Ablation System (MTX-100) in the USA.
The MTX-100 was developed by BSD to provide treatments as a stand-alone therapy, rather than only in combination with other therapies. It also introduces into the company’s product line a major disposable used in each treatment, providing an ongoing revenue stream after the system sale.

The MTX-100 was designed to introduce new versatility and capabilities for use in ablation therapy and to provide ease and simplicity of use for busy interventional radiologists and surgeons. Using microwaves in treatments, the MTX-100 competes head-on with RF ablation technologies that require patient grounding pads.

BSD employed its extensive background in designing systems that deliver thermal medicine by equipping the MTX-100 with the ability to use up to four treatment applicators simultaneously, working intelligently together through BSD’s phased array technology to provide larger and more uniform zones of ablation during a single procedure.

To evaluate the ease of use of the MTX-100, BSD conducted usability testing on the MTX-100 at nine clinical sites involving 35 medically trained users who were experienced in thermal ablation procedures. Measures of effectiveness and satisfaction were taken during testing that was designed to evaluate satisfaction in using the system, user performance of work tasks, user interface design and the instructions for use.

The participants were able to effectively complete a simulated ablation procedure with no prior training on the system operations by using the instructions for use and the interactive screen displays. The system operations, instructions for use and user interface designs were shown to be user friendly and intuitive, and the participants confirmed the favorable ease of use of the MTX-100.

The MTX-100 is a compact, mobile system that includes a state-of-the-art computer, a microwave generator, single-patient-use disposable applicators and a proprietary thermistor-based temperature monitoring system. The delivery of microwave energy is controlled by time and power parameters set by the operator utilising an interactive touch-screen monitor that allows the operator to quickly and easily control the treatment.

The MTX-100 provides minimally invasive access to the target tissue and can be used in open surgical as well as in percutaneous ablation procedures, which will allow the MTX-100 to be used by both surgeons and interventional radiologists. The MTX-100 is indicated for use in ablation of soft tissues.
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