MRI Interventions' ClearPoint System Utilized at Cincinnati Children's Hospital for Neurosurgical Shunt Placement
MRI Interventions, Inc. (OTCQB:MRIC) today announced that the first real-time MRI-guided neurosurgical shunt placement using the company's ClearPoint® Neuro Intervention System has been performed at Cincinnati Children's Hospital, representing the latest application of the platform system and illustrating its utility in a wide range of neurosurgical procedures.
Dr. Ellen Air, neurosurgeon at Cincinnati Children's Hospital, performed the shunt placement procedure under real-time MRI guidance and direct visualization enabled by the ClearPoint System. Shunts are used to relieve fluid build-up in and around the brain by draining the fluid. Often, the target for a neurological shunt placement is relatively large – for instance, a ventricle. In Dr. Air's case, the target was a cyst deep in the brain, requiring careful navigation to the target and precise placement of the shunt catheter.
"I elected to perform the procedure under real-time MRI-guidance and direct visualization because accuracy was particularly important in this shunt placement operation," said Dr. Air. "The intra-procedural visualization provided by the system helped me avoid critical neurological and vascular structures in the brain, and real-time MRI guidance allowed for optimal positioning of the catheter to achieve optimal drainage of the cyst."
The ClearPoint System is the only technology that enables minimally-invasive neurosurgery under continuous MRI guidance, which provides superior visualization of the brain's tissue compared to other imaging technologies and can be run continuously throughout surgery. The ClearPoint System's use in a shunt placement operation demonstrates the expanding utility of the platform, which has been used to assist with asleep deep brain stimulation procedures, laser ablation therapy and brain biopsy, and is currently involved in five clinical trials investigating direct drug delivery in the brain.
About the ClearPoint System
The ClearPoint System is a navigation platform designed to allow real-time, direct visualization during minimally-invasive neurosurgical procedures. ClearPoint software works with MRI to assist surgeons in planning a target and trajectory, and the SmartFrame® targeting device enables the MRI-guided alignment and insertion of surgical instruments. The ClearPoint System has been used to assist with asleep DBS procedures, laser ablation therapy and brain biopsy, and is currently involved in five clinical trials investigating direct drug delivery in the brain.
The ClearPoint SmartFlow® cannula is presently FDA-cleared for injection of cytarabine, a chemotherapy drug, to the ventricles or removal of CSF from the ventricles during intracranial procedures. Delivery of other therapeutic agents using the SmartFlow cannula is investigational.
About MRI Interventions, Inc.
Founded in 1998, MRI Interventions is creating innovative platforms for performing the next generation of minimally invasive surgical procedures in the brain and heart. Utilizing a hospital's existing MRI suite, the company's FDA-cleared ClearPoint® system is designed to enable a range of minimally invasive procedures in the brain. In partnership with Siemens Healthcare, MRI Interventions is developing the ClearTrace® system to enable MRI-guided catheter ablations to treat cardiac arrhythmias, including atrial fibrillation. Building on the imaging power of MRI, the company's interventional platforms strive to improve patient care while reducing procedure costs and times. MRI Interventions is also working with Boston Scientific Corporation to incorporate its MRI-safety technologies into Boston Scientific's implantable leads for cardiac and neurological applications. For more information, please visit www.mriinterventions.com.
Forward-Looking Statements
Certain matters in this press release may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements often can be identified by words such as "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would," or the negative of these words or other words of similar meaning. Forward-looking statements by their nature address matters that, to different degrees, are uncertain and involve risk. Uncertainties and risks may cause MRI Interventions' actual results and the timing of events to differ materially from those expressed in or implied by MRI Interventions' forward-looking statements. Particular uncertainties and risks include, among others: demand and market acceptance of our products; our ability to successfully expand our sales and marketing capabilities; our ability to successfully complete the development of, and to obtain regulatory clearance or approval for, future products, including our current product candidates; availability of third party reimbursement; the sufficiency of our cash resources to maintain planned commercialization efforts and research and development programs; future actions of the FDA or any other regulatory body that could impact product development, manufacturing or sale; our ability to protect and enforce our intellectual property rights; our dependence on collaboration partners; the impact of competitive products and pricing; and the impact of the commercial and credit environment on us and our customers and suppliers. More detailed information on these and additional factors that could affect MRI Interventions' actual results are described in MRI Interventions' filings with the Securities and Exchange Commission, including, without limitation, MRI Interventions' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 13, 2013. Except as required by law, MRI Interventions undertakes no obligation to publicly update or revise any forward-looking statements contained in this press release to reflect any change in MRI Interventions' expectations or any change in events, conditions or circumstances on which any such statements are based.
CONTACT: MRI Interventions, Inc.
David Carlson, CFO, 901-522-9300
MRI Interventions, Inc. (OTCQB:MRIC) today announced that the first real-time MRI-guided neurosurgical shunt placement using the company's ClearPoint® Neuro Intervention System has been performed at Cincinnati Children's Hospital, representing the latest application of the platform system and illustrating its utility in a wide range of neurosurgical procedures.
Dr. Ellen Air, neurosurgeon at Cincinnati Children's Hospital, performed the shunt placement procedure under real-time MRI guidance and direct visualization enabled by the ClearPoint System. Shunts are used to relieve fluid build-up in and around the brain by draining the fluid. Often, the target for a neurological shunt placement is relatively large – for instance, a ventricle. In Dr. Air's case, the target was a cyst deep in the brain, requiring careful navigation to the target and precise placement of the shunt catheter.
"I elected to perform the procedure under real-time MRI-guidance and direct visualization because accuracy was particularly important in this shunt placement operation," said Dr. Air. "The intra-procedural visualization provided by the system helped me avoid critical neurological and vascular structures in the brain, and real-time MRI guidance allowed for optimal positioning of the catheter to achieve optimal drainage of the cyst."
The ClearPoint System is the only technology that enables minimally-invasive neurosurgery under continuous MRI guidance, which provides superior visualization of the brain's tissue compared to other imaging technologies and can be run continuously throughout surgery. The ClearPoint System's use in a shunt placement operation demonstrates the expanding utility of the platform, which has been used to assist with asleep deep brain stimulation procedures, laser ablation therapy and brain biopsy, and is currently involved in five clinical trials investigating direct drug delivery in the brain.
About the ClearPoint System
The ClearPoint System is a navigation platform designed to allow real-time, direct visualization during minimally-invasive neurosurgical procedures. ClearPoint software works with MRI to assist surgeons in planning a target and trajectory, and the SmartFrame® targeting device enables the MRI-guided alignment and insertion of surgical instruments. The ClearPoint System has been used to assist with asleep DBS procedures, laser ablation therapy and brain biopsy, and is currently involved in five clinical trials investigating direct drug delivery in the brain.
The ClearPoint SmartFlow® cannula is presently FDA-cleared for injection of cytarabine, a chemotherapy drug, to the ventricles or removal of CSF from the ventricles during intracranial procedures. Delivery of other therapeutic agents using the SmartFlow cannula is investigational.
About MRI Interventions, Inc.
Founded in 1998, MRI Interventions is creating innovative platforms for performing the next generation of minimally invasive surgical procedures in the brain and heart. Utilizing a hospital's existing MRI suite, the company's FDA-cleared ClearPoint® system is designed to enable a range of minimally invasive procedures in the brain. In partnership with Siemens Healthcare, MRI Interventions is developing the ClearTrace® system to enable MRI-guided catheter ablations to treat cardiac arrhythmias, including atrial fibrillation. Building on the imaging power of MRI, the company's interventional platforms strive to improve patient care while reducing procedure costs and times. MRI Interventions is also working with Boston Scientific Corporation to incorporate its MRI-safety technologies into Boston Scientific's implantable leads for cardiac and neurological applications. For more information, please visit www.mriinterventions.com.
Forward-Looking Statements
Certain matters in this press release may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements often can be identified by words such as "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would," or the negative of these words or other words of similar meaning. Forward-looking statements by their nature address matters that, to different degrees, are uncertain and involve risk. Uncertainties and risks may cause MRI Interventions' actual results and the timing of events to differ materially from those expressed in or implied by MRI Interventions' forward-looking statements. Particular uncertainties and risks include, among others: demand and market acceptance of our products; our ability to successfully expand our sales and marketing capabilities; our ability to successfully complete the development of, and to obtain regulatory clearance or approval for, future products, including our current product candidates; availability of third party reimbursement; the sufficiency of our cash resources to maintain planned commercialization efforts and research and development programs; future actions of the FDA or any other regulatory body that could impact product development, manufacturing or sale; our ability to protect and enforce our intellectual property rights; our dependence on collaboration partners; the impact of competitive products and pricing; and the impact of the commercial and credit environment on us and our customers and suppliers. More detailed information on these and additional factors that could affect MRI Interventions' actual results are described in MRI Interventions' filings with the Securities and Exchange Commission, including, without limitation, MRI Interventions' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 13, 2013. Except as required by law, MRI Interventions undertakes no obligation to publicly update or revise any forward-looking statements contained in this press release to reflect any change in MRI Interventions' expectations or any change in events, conditions or circumstances on which any such statements are based.
CONTACT: MRI Interventions, Inc.
David Carlson, CFO, 901-522-9300
