Clearance Resolves Outstanding FDA Advisory Notice Issues
IRVINE, Calif., Oct. 24, 2018 (GLOBE NEWSWIRE) -- MRI Interventions (OTCQB:MRIC) congratulates Monteris Medical on the FDA Clearance of its new NeuroBlate Optic Laser Probe. The new probe replaces a previous metallic thermocouple with a non-metallic fiber optic temperature sensor, eliminating risk of unintended probe heating and addressing prior concerns noted in an FDA field advisory notice.
“We are thrilled to see one of the leaders in laser ablation surgery respond so quickly to the FDA requests and resolve any outstanding issues for this exciting product,” commented Joe Burnett, President and CEO at MRI Interventions. “Laser ablation neurosurgery is a truly pivotal step toward MRI-guided minimally invasive procedures. We believe the small incisions combined with ClearPoint® live-image guidance will continue to be a preferred choice for many patients in the years ahead. We are excited to participate in the laser ablation space supporting both navigation and therapy, and to work with other industry leaders to further develop the market for these valuable procedures.”
According to Monteris, the NeuroBlate System has been used in more than 2,000 patient procedures across 60 installed systems in the U.S. and Canada since receiving FDA 510(k) clearance in 2013.
MRI Interventions’ ClearPoint system provides guidance for the placement and operation of instruments and devices during neurological procedures within the MRI environment. We believe the added guidance and functionality of the ClearPoint System make it an ideal delivery platform to place laser ablation devices at precisely targeted areas in the brain. Using the ClearPoint system to deliver laser ablation therapy, the surgeon sees and selects the desired neurological target, aims the SmartFrame trajectory device, and watches under real-time MRI guidance as the laser probe is advanced through the SmartFrame to the target. Energy is then delivered to the target area through the laser probe, which destroys the unwanted tissue. Because the procedure is performed within the MRI environment, the surgeon is able to monitor brain tissue temperature throughout the procedure, and to verify that the targeted tissue has been destroyed.
About MRI Interventions, Inc.
Building on the power of magnetic resonance imaging (“MRI”), MRI Interventions is creating innovative platforms for performing the next generation of minimally invasive surgical procedures in the brain. The ClearPoint Neuro Navigation System, which has received 510(k) clearance and is CE marked, utilizes a hospital’s existing diagnostic or intraoperative MRI suite to enable a range of minimally invasive procedures in the brain. For more information, please visit www.mriinterventions.com.
Statements herein concerning MRI Interventions, Inc.’s plans, growth and strategies may include forward-looking statements within the context of the federal securities laws. Statements regarding the company's future events, developments and future performance, as well as management's expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. Uncertainties and risks may cause the company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: the Company’s ability to obtain additional financing; estimates regarding the sufficiency of the Company’s cash resources; future revenues from sales of the company’s ClearPoint Neuro Navigation System products; and the company’s ability to market, commercialize and achieve broader market acceptance for the company’s ClearPoint Neuro Navigation System products. More detailed information on these and additional factors that could affect the company’s actual results are described in the “Risk Factors” section of the company’s Annual Report on Form 10-K for the year ended December 31, 2017, and its Quarterly Report on Form 10-Q for the three months ended June 30, 2018, both of which have been filed with the Securities and Exchange Commission.