$MRIC MRI Interventions' ClearPoint System Facilitates Asleep DBS Surgery at San Francisco VA Medical Center for Veterans With Park...
MRI Interventions, Inc. (OTCQB:MRIC) today announced that Veterans Affairs Medical Center (VAMC) in San Francisco, California, has become the first VA hospital to offer MRI-guided asleep deep brain stimulation (DBS) surgery to veterans suffering from Parkinson's disease. Dr. Paul Larson, Chief of Neurosurgery at the San Francisco VAMC, led the center's first asleep DBS procedure on October 25, 2013, using the ClearPoint® Neuro Intervention System's real-time MRI guidance and visualization to plan, target, and confirm results of the surgery, all within the hospital's diagnostic MRI suite.
"I am happy to be able to extend the asleep DBS option to veterans struggling with Parkinson's disease," stated Dr. Larson. "Anatomical targeting with the ClearPoint System is very accurate and allows us to reach the desired location for electrode placement on the first pass in the vast majority of cases, without awake patient participation. The result is that our patients get to sleep through surgery, which can take away some of the anxiety leading up to a procedure."
DBS therapy is an important treatment option for many patients with Parkinson's disease whose symptoms are not adequately controlled with medication. The therapy involves the delivery of electrical signals to specific locations within the brain to relieve some of the debilitating symptoms of Parkinson's disease, such as tremor. Patients who undergo the treatment could experience a significant reduction in symptoms, with life-changing results. The opportunity to rest under general anesthesia during surgery makes DBS an option for many patients who otherwise could not tolerate an awake procedure or might avoid it.
The ClearPoint System at the San Francisco VAMC was installed in the center's Siemens 3T diagnostic MRI scanner. The ClearPoint platform 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. Using the ClearPoint System, a surgeon sees and selects a neurological target, aims the ClearPoint targeting device and watches via MRI as the surgical instrument is advanced to the target location inside the patient's brain. The surgeon can then immediately confirm results of the procedure with MRI before removing the patient from the operating environment.
In addition to asleep DBS, the ClearPoint System has been used to enable 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 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 and CE-marked 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 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 clinical support capabilities; 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 Veterans Affairs Medical Center (VAMC) in San Francisco, California, has become the first VA hospital to offer MRI-guided asleep deep brain stimulation (DBS) surgery to veterans suffering from Parkinson's disease. Dr. Paul Larson, Chief of Neurosurgery at the San Francisco VAMC, led the center's first asleep DBS procedure on October 25, 2013, using the ClearPoint® Neuro Intervention System's real-time MRI guidance and visualization to plan, target, and confirm results of the surgery, all within the hospital's diagnostic MRI suite.
"I am happy to be able to extend the asleep DBS option to veterans struggling with Parkinson's disease," stated Dr. Larson. "Anatomical targeting with the ClearPoint System is very accurate and allows us to reach the desired location for electrode placement on the first pass in the vast majority of cases, without awake patient participation. The result is that our patients get to sleep through surgery, which can take away some of the anxiety leading up to a procedure."
DBS therapy is an important treatment option for many patients with Parkinson's disease whose symptoms are not adequately controlled with medication. The therapy involves the delivery of electrical signals to specific locations within the brain to relieve some of the debilitating symptoms of Parkinson's disease, such as tremor. Patients who undergo the treatment could experience a significant reduction in symptoms, with life-changing results. The opportunity to rest under general anesthesia during surgery makes DBS an option for many patients who otherwise could not tolerate an awake procedure or might avoid it.
The ClearPoint System at the San Francisco VAMC was installed in the center's Siemens 3T diagnostic MRI scanner. The ClearPoint platform 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. Using the ClearPoint System, a surgeon sees and selects a neurological target, aims the ClearPoint targeting device and watches via MRI as the surgical instrument is advanced to the target location inside the patient's brain. The surgeon can then immediately confirm results of the procedure with MRI before removing the patient from the operating environment.
In addition to asleep DBS, the ClearPoint System has been used to enable 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 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 and CE-marked 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 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 clinical support capabilities; 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
