Ever since the 1950s neurosurgeons have been using static images, taken prior to the procedure, to guide them through an operation. Brain surgeries performed in this manner are based a great deal on trial and error, and require the patient to stay awake as the surgeon painstakingly works for hours to determine if the therapy reached the correct location in the brain. Now, MRI Interventions, an Irvine, CA company, is developing a novel technology called Clearpoint that uses real time, intra-procedural magnetic resonance imaging to guide neurological procedures. The Clearpoint system is intended to be used for treatment of Parkinson’s disease, epilepsy, and pediatric dystonia, and is currently in clinical trials to deliver drugs for brain cancer. We had the opportunity to speak with Kim Jenkins, CEO of MRI Interventions, to learn more about the Clearpoint system and its benefits for neurosurgeons.
Gaurav Krishnamurthy, Medgadget: What is the problem that MRI Interventions is solving? What is your primary offering?
Kim Jenkins: Real-time image guidance has revolutionized surgical procedures in numerous fields over the past few decades, providing surgeons with the ability to perform minimally invasive operations with increased visualization. For example, in orthopedic surgery, arthroscopic visualization now enables 1.2 million minimally invasive procedures a year. Fluoroscopic visualization guides 1.4 million cardiovascular interventions each year. And over four million minimally invasive abdominal surgeries are performed each year using laparoscopic visualization. In each of these cases, real-time intraoperative imaging satisfies the need for surgeons to see their work while simultaneously minimizing the risk to patients. The result is increased availability of these therapies to a greater number of patients who did not make good candidates for the more invasive open surgeries, a large reduction in costs and a drastic transformation of each field.
In contrast, minimally invasive neurosurgery is still performed “blind,” without real-time image guidance in most cases. Talented, highly specialized surgeons must rely even today on outdated tools that do not enable intraoperative visualization. MRI images are taken hours before surgery and co-registered to a patient’s stereotactic head frame. These dated, static images are the only detailed anatomical images available to surgeons during surgery. Because the images demonstrate the positioning of the brain before the procedure, in many procedures surgeons must insert special listening electrodes into the patient’s brain in a process known as microelectrode recording, using neuronal firings to augment the prior-obtained visual data. And finally, patients are kept awake and off medication during the procedure in order to provide physiological feedback that further helps guide and confirm the delivery of the therapy.
There is an alternative to this conventional process, however. We believe our ClearPoint Neuro Intervention system makes neurosurgery simpler for surgeons and more comfortable for patients by enabling real-time, intraoperative image guidance using high-resolution MR images to allow the surgeon to see inside of a patient’s brain in real time.
Our goal is to have a transformational impact on the way neurosurgery is performed by delivering solutions for the issues inherent in conventional neurosurgical procedures. In doing so, we hope to provide the catalyst for a revolution in neurosurgery—using real-time visualization to modernize this field as it was used to modernize the fields of cardiovascular, abdominal and orthopedic surgery.
Medgadget: Can you briefly explain how the Clearpoint System works?
Kim Jenkins: The ClearPoint System is an integrated system of intuitive, menu-driven software, disposable components and reusable hardware that works within a hospital’s standard, existing diagnostic MRI suite.
Patients undergoing a ClearPoint procedure are first placed under general anesthesia. The patient’s head rests inside an MR imaging head coil and fixation frame. An MRI-visible matrix called the SmartGrid® is applied to the patient’s head, and the patient is advanced into the isocenter of the MRI scanner to start the procedure. The MRI scanner begins obtaining high-resolution images of the patient’s neurological anatomy and communicates the images in DICOM format to the ClearPoint workstation, which presents the images to the physician via the ClearPoint software.
From these high-resolution images, the surgeon sees and selects the neurological target. Once the target is selected, the surgeon uses ClearPoint software to find an optimal trajectory from the surface of the skull down to the neurological target in the brain. The software assists in this process by visualizing critical structures that need to be avoided, such as blood vessels, sulci and the ventricles. With the trajectory determined, the entry point is then identified on the patient’s head via the SmartGrid. The ClearPoint software recognizes where the planned trajectory passes through the MR-visible SmartGrid and identifies the specific coordinates to the physician. The top layer of the SmartGrid is then peeled back and the coordinates are used to guide the surgeon in marking the location of the entry point on the patient’s head.
After a small entry point is created, the surgeon affixes the SmartFrame device to the patient’s head. The SmartFrame is a precision-geared device with four degrees of freedom—pitch, roll, X and Y—that are actuated with four small, color-coded control knobs. Similar to the SmartGrid, the SmartFrame trajectory guide is also MRI-visible. With the SmartFrame attached to the patient, another set of high-resolution images is acquired and presented to the physician to reconfirm the location of the neurological target and the optimal trajectory. The new images take into account any shift in the brain that might have occurred during the procedure.
With the SmartFrame and patient anatomy in a common 3-D imaging surgical space, the interventional portion of the procedure is simple. The ClearPoint software is aware of both the planned trajectory and the SmartFrame trajectory. The software then guides the surgeon in the adjustment of the SmartFrame control knobs until the SmartFrame trajectory is aligned with the planned trajectory. With the SmartFrame properly aligned, the surgeon then inserts the interventional device through the center lumen of the trajectory frame. As the device is advanced through the brain, the surgeon observes real-time images to ensure that no undesirable events have taken place, such as hemorrhage, and to confirm that the desired neurological target has been reached.
Medgadget: How is the ClearPoint technology better than other surgical methods?
Kim Jenkins: The ClearPoint System is the only platform for neurosurgery that enables real-time, detailed intraoperative visualization throughout a procedure. MRI is the gold standard for imaging the soft tissue of the brain. It is the only imaging modality by which one can view tiny neurological substructures—the subthalamic nucleus, globus pallidus or the rim of a brain tumor, for instance—that are the targets of many neurosurgeries.
Due to the intraoperative real-time visualization enabled by the ClearPoint System, surgery with the platform is very accurate, within an average of 0.6 mm radial error, allowing surgeons to target areas in the brain the size of a single sesame seed.
Medgadget: How does this technology benefit the patients, surgeons and hospitals?
Kim Jenkins: We believe that innovation in healthcare today must deliver benefits to all stakeholders involved in a medical procedure. We believe ClearPoint accomplishes this objective.
Benefits to patients:
For patients, ClearPoint technology has several benefits. Most importantly, patients can sleep through ClearPoint DBS procedures, in contrast to the conventional procedure that is typically performed while they are awake. For certain patients suffering from epilepsy or brain tumor, ClearPoint may enable a minimally invasive laser ablation procedure, in lieu of a surgical resection via an open craniotomy. In general, less-invasive procedures tend to have shorter recovery times and fewer associated comorbidities.
Benefits to surgeons:
ClearPoint technology provides neurosurgeons the ability to see surgical instruments and the patient’s brain in real time during a procedure. Intra-procedural visualization for the surgeon resolves issues regarding patient comfort during surgery, but also facilitates treatment for patients who, without ClearPoint, would not make good candidates for neurosurgery. Children suffering from debilitating pediatric dystonia whose medications are no longer adequate, for instance, often do not make good candidates for awake DBS surgery. The ability to see inside the patients’ brains while they sleep allows surgeons to extend treatment options to these and other patients who otherwise might have none. Additionally, ClearPoint’s visual guidance might facilitate new therapies to treat difficult neurological conditions in which an anatomical target is known, giving surgeons the opportunity to provide more treatment options for more patients. Finally, the ClearPoint System’s intra-procedural visualization and guidance also enhance surgical efficiencies, which can lead to shorter surgical times, increasing the number of patients who can be treated in a given day.
Benefits to hospitals:
ClearPoint makes neurosurgeries shorter, simpler and more efficient for hospitals. Because ClearPoint can reduce procedure times, hospitals might be able to treat more patients in less time than with conventional surgical methods. Since ClearPoint works in a hospital’s existing diagnostic MRI suite, hospitals can realize greater efficiencies by utilizing infrastructure the hospital already owns. As a point of reference, there are well over 5,000 diagnostic MRI scanners already in place in hospitals throughout the U.S.
Medgadget: When will this technology be available on the market? Has it received regulatory approval?
Kim Jenkins: ClearPoint is FDA-approved and CE-marked. As of September 30, 2013, 27 hospitals in the U.S. and two in Europe have adopted our system. This number continues to grow. Five of the top 10 hospitals listed in the 2013 U.S. News and World Report’s Top-Ranked Hospitals for Neurology and Neurosurgery possess a ClearPoint system. Neurosurgeons use the ClearPoint System to enable “asleep” DBS procedures to treat movement disorders such as Parkinson’s disease and dystonia, and focal laser ablation for treatment-resistant epilepsy and brain tumors.
Opportunity exists for the ClearPoint system to play a significant role in changing the field of neurological drug delivery. The ClearPoint system is involved in five drug delivery clinical trials, including two trials for Parkinson’s disease and three trials for brain tumors. In the trials, our ClearPoint system is utilized to enable direct delivery of investigational therapies to specific target areas in the brain. Through our involvement in these clinical trials, MRI Interventions is working with a number of leaders in the field of drug delivery, including biotech companies Sanofi Genzyme, UniQure, B.V. and Tocagen, Inc., and research centers University of California, San Francisco (UCSF), National Institutes of Health (NIH), Memorial Sloan-Kettering Cancer Center (MSKCC) and University of California, San Diego (UCSD).
Medgadget: Everyone is talking about healthcare costs at the moment. Do you think your device can be integrated into current brain surgical procedures without significantly raising the cost of the procedure?
Kim Jenkins: Our objective is to deliver better healthcare solutions for patients at a lower cost. This purpose is closely matched with domestic healthcare policy, such as that found in the Affordable Care Act, as well as healthcare policies around the world. We believe ClearPoint is helping meet this goal by moving neurosurgery into the 21st century with real-time visual guidance, driving surgical and departmental efficiencies, providing additional utility to hospitals’ existing infrastructure and offering a less-invasive alternative to a number of neurosurgical procedures. The sum of all of our efforts comes down to bringing better solutions to the people at the very center of the healthcare system—patients.
Product page: ClearPoint…