MRI Interventions, Inc. and BrainLAB AG Launch European Commercialization Effort with First ClearPoint Case in Europe
Published: Sep 20, 2012
MEMPHIS, Tenn. and MUNICH, Sept. 19, 2012 /PRNewswire/ -- MRI Interventions, Inc. (OTCBB:MRIC) and Brainlab AG announced today that Prof. Stephan Chabardes at Universite Joseph Fourier (UJF) Hospital in Grenoble, France has performed the first two cases in Europe with the ClearPoint® Neuro Intervention System. Prof. Chabardes used the ClearPoint system to assist with the implantation of deep brain stimulation (DBS) leads in two patients suffering from Parkinson's disease. In addition to being the first ClearPoint commercial cases in Europe, the cases carried the historical significance of being performed at the location where DBS treatment was originally developed.
DBS therapy is a reversible and adjustable treatment for a variety of neurological disorders by which an electronic lead is placed at a targeted location inside the brain and connected to a pulse generator that is implanted under the skin in the patient's chest area. The pulse generator is set to a customized frequency, and it delivers small electrical pulses to the target area of the brain. The device, which some refer to as a "pacemaker for the brain," is used to suppress disabling symptoms associated with the particular neurological disorder being treated. Since its inception 25 years ago, DBS has become an important and established treatment that has improved the quality of life for over 80,000 people.
The traditional surgical technique for implanting DBS leads has been performed without intra-procedural visualization, meaning that the surgeon cannot see the neurological target and surgical devices inside the brain while the procedure is being performed. By contrast, the next generation ClearPoint system provides surgeons with direct, real-time visualization of the patient's anatomy and the surgical devices throughout the procedure. Using the ClearPoint system, the surgeon sees and selects the neurological target, aims the ClearPoint targeting device, and watches via magnetic resonance imaging (MRI) as the surgical tool is advanced to the target.
"The cases went well and we are very pleased to have performed the first ClearPoint procedures in Europe," said Prof. Chabardes. "The move to real-time, MRI-guidance for minimally invasive neurosurgical procedures is inevitable and the ClearPoint system is now bringing these capabilities to the clinic."
"We are very pleased to formally launch our European ClearPoint commercialization effort with initial cases in Grenoble, a significant site to neurosurgeons and their patients around the world for its role in pioneering DBS therapy," said Kimble Jenkins, CEO of MRI Interventions. "This activity in Europe builds on the growth we are seeing in the United States, where ClearPoint systems have already been installed in 16 sites."
About MRI Interventions
Founded in 1998, MRI Interventions, Inc. 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, MRI Interventions' FDA-cleared ClearPoint® system is designed to enable a range of minimally invasive procedures in the brain. MRI Interventions has a co-development and co-distribution agreement with Brainlab, a leader in software-driven medical technology, relating to the ClearPoint system. 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, MRI Interventions' interventional platforms strive to improve patient outcomes while reducing procedure costs and times. MRI Interventions is also working with Boston Scientific Corporation to incorporate MRI Interventions' MRI-safety technologies into Boston Scientific's implantable leads for cardiac and neurological applications. For more information, visit www.MRIinterventions.com.
Founded in 1989, the privately held Brainlab group has more than 5,000 systems installed in about 80 countries. Based in Munich, Germany, Brainlab employs 1,070 people in 17 offices worldwide. Brainlab develops, manufactures and markets software-driven medical technology that supports targeted, less-invasive treatment. Core products are image-guided systems and software that provide real-time information used for surgical navigation and radiosurgical planning and delivery. Brainlab technology drives collaboration between hospitals and clinicians from a wide variety of subspecialtiesfrom neurosurgery and oncology to orthopedics, ENT, CMF and spine and trauma. This integration delivers better access to improved and more efficient treatment. To learn more, visit www.brainlab.com.
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. For MRI Interventions, particular uncertainties and risks include, among others: demand and market acceptance of its products; its ability to successfully complete the development of, and to obtain regulatory clearance or approval for, future products, including its current product candidates; availability of third party reimbursement; the sufficiency of its 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; its ability to protect and enforce its intellectual property rights; its dependence on collaboration partners; the retention of its sales representatives and independent distributor; the impact of competitive products and pricing; and the impact of the commercial and credit environment on it and its 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, the quarterly report on Form 10-Q for the quarterly period ended June 30, 2012. 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.
MRI Interventions, Inc.
SOURCE MRI Interventions, Inc.