ViewRay, Inc. announced that the company received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the MRIdian Linac system, the company’s next generation linear accelerator-based MRI-guided radiation therapy system.
“FDA clearance of the MRIdian Linac is a transformative milestone for ViewRay,” said Chris A. Raanes, president and chief executive officer of ViewRay. “We believe that availability of the world’s first commercial system to combine MRI for soft-tissue visualization and a compact linear accelerator will lead to a new standard of care in radiation oncology. Clinical experience with ViewRay’s first generation MRIdian System has demonstrated the benefits of on-table adaptive therapy and real-time MRI guidance, as clinicians are seeing for the first time how much tumors and organs move and change shape during the course of treatment.”
The first two MRIdian Linac systems in the United States are expected to be installed at Henry Ford Hospital in Detroit and Barnes-Jewish Hospital at Washington University in St. Louis.
“Radiation oncologists have long awaited the availability of a clinical system that integrates MR-imaging with linac radiation delivery, as this is a major breakthrough in improving the efficacy of radiation therapy for patients,” said Benjamin Movsas, M.D., chairman of Radiation Oncology at the Henry Ford Cancer Institute in Michigan. “At the Henry Ford Cancer Institute, we’re proud to be among the first centers to offer treatment with MRIdian Linac. The ability to see what’s happening inside the body while the patient is undergoing radiation therapy and ensure the radiation continually remains on target is a huge leap forward and will help us to improve patient outcomes.”
“With MRI-guided radiation therapy, we’re able to watch the movement of tumors and organs in the body as radiation is being delivered and adapt the dose of radiation in real-time, to help ensure the maximum dose reaches the tumor and that surrounding healthy tissue is spared,” said Sasa Mutic, Ph.D., director of Radiation Oncology Physics at Washington University School of Medicine. “This technology helps us treat tumors such those in the lung, liver and pancreas where increased precision is important due to nearby organs and other critical structures.”
A unique new imaging method, called “polarized nuclear imaging” – combining powerful aspects of both magnetic resonance imaging and gamma-ray imaging and developed by physicists in the University of Virginia’s departments of Physics and Radiology – has potential for new types of high-resolution medical diagnostics as well as industrial and physics research applications.
Affecting 33.5 million patients worldwide, atrial fibrillation is the most common form of cardiac arrhythmia. As if having an irregular heart beat wasn’t troubling enough, patients with atrial fibrillation are also much more likely to have a stroke.
“Atrial fibrillation is thought to be responsible for 20 to 30 percent of all strokes in the United States,” said Northwestern’s Michael Markl, the Lester B. and Frances T. Knight Professor of Cardiac Imaging. “While atrial fibrillation is easy to detect and diagnose, it’s not easy to predict who will suffer a stroke because of it.”
Markl, who is a professor of biomedical engineering in the McCormick School of Engineering and of radiology in the Feinberg School of Medicine, has developed a new imaging technique that can help predict who is most at risk for stroke. This breakthrough could lead to better treatment and outcomes for patients with atrial fibrillation.
Atrial fibrillation is linked to stroke because it slows the patient’s blood flow. The slow, sluggish blood flow can lead to blood clots, which can then travel to the brain and initiate stroke. Markl’s cardiac magnetic resonance (CMR) imaging test can detect the blood’s velocity through the heart and body. Called “atrial 4D flow CMR,” the technique is non-invasive and does not require contrast agents. The imaging program, which images blood flow dynamically and in the three spatial dimensions, comes in the form of software that can also be integrated into current MRI equipment without the need of special hardware and scanners or equipment upgrades.
Historically, physicians have attempted to assess stroke risk in atrial fibrillation patients by using a risk scoring system, which takes risk factors, such as age, general health, and gender, into account. Higher risk patients are then given medicine to prevent blood clots that lead to stroke.
“It’s very well accepted that these therapies significantly reduce the risk of stroke,” Markl said. “But they also increase risk of bleeding complications. It’s a dilemma that physicians face. They want to reduce one risk without introducing another risk. It’s particularly difficult for younger patients who might be on these medications for a long period of time. Maybe the risk of bleeding is initially small. But after taking medication for 20 or 30 years, it’s more and more likely that they’ll experience complications.”
Markl’s 4D flow imaging technique can give a more precise assessment of who needs the medication, preventing physicians from over treating their patients. In a pilot study with 60 patients and a control group, Markl found that atrial fibrillation patients who would have been considered high risk for stroke by the traditional scoring system in fact had normal blood flow, while patients who were considered lower risk sometimes had the slow blood flow indicative of potential clotting.
INSIGHTEC announced the signing of a strategic agreement with the global leader in Magnetic Resonance Imaging, Siemens Healthineers. The strategic collaboration will involve the development of compatibility between Exablate Neuro and Siemens leading 1.5T and 3T clinical MRI systems, MAGNETOM Aera and Skyra. With this agreement, Siemens Healthineers follows its strategy of broadening and complementing its diagnostic imaging portfolio with advanced therapy solutions. Both parties will work towards providing access to Exablate Neuro for installed base, as well as new product installation customers.
Exablate Neuro is the world’s first and only CE and FDA-approved device for the non-invasive application of MR guided focused ultrasound to treat essential tremor and other conditions. Clinical research, development and regulatory approvals are ongoing for additional neurosurgical applications and markets.
“Our agreement with Siemens Healthineers will allow us to significantly expand Exablate Neuro’s market presence. Siemens has embraced our technology and together we will bring our therapy to significantly more patients and providers,” said Maurice R. Ferré MD, INSIGHTEC Chief Executive Officer and Chairman of the Board. “INSIGHTEC is committed to continue investing in research and development of MRgFUS technology. The strategic collaboration with Siemens Heathineers will allow more patients and researchers globally to benefit from the unique MRgFUS technology,” he concluded.
Christoph Zindel, MD, Senior Vice President and General Manager of SIEMENS Healthineers’ Magnetic Resonance business further highlights the importance of the agreement: “This strategic partnership of two leading organizations is exciting and further underlines Siemens Healthineers’ strategy of enabling better patient outcomes by broadening its diagnostic imaging portfolio into advanced therapies in the area of neurological and other disorders. Together with INSIGHTEC and its innovative technology, we will jointly drive healthcare further together with our strong research and clinical customer network worldwide.”
Exablate Neuro uses focused ultrasound waves to precisely target and accurately ablate tissue deep within the brain with no incisions, and while minimizing damage to adjacent healthy tissue. Siemens MR imaging plans to provide patient-specific treatment planning and continuous temperature monitoring for assessing treatment outcome in real-time during Exablate Neuro procedures.
Boston Scientific has received CE Mark approval for the new EMBLEM™ MRI Subcutaneous Implantable Defibrillator (S-ICD) System, as well as magnetic resonance (MR) conditional labeling for all previously implanted EMBLEM S-ICD Systems.
The EMBLEM S-ICD Systems are treatment options for patients at risk of sudden cardiac arrest (SCA) that leave the heart and vasculature untouched, reducing the risk of complications associated with transvenous implantable cardioverter-defibrillators (TV-ICDs). Initial market release of the new EMBLEM MRI S-ICD System has begun in a small number of European centers with a broad European launch scheduled for early this summer.
In Europe, the EMBLEM MRI S-ICD System joins the growing family of ImageReady™ MR-conditional devices, all of which are labeled safe for use in a magnetic resonance image setting when conditions of use are met. Patients receiving the EMBLEM MRI S-ICD System as well as patients who previously were implanted with an EMBLEM S-ICD System are now able to undergo full-body MR scans safely in 1.5 Tesla environments when conditions of use are met.
“These approvals give reassurance to physicians and their patients that they have access to any future MR scan needs, and underscores the Boston Scientific commitment to gain MR-conditional labeling on high-voltage devices that are being implanted today,” said Kenneth Stein, M.D., chief medical officer, Rhythm Management, Boston Scientific. “Further, the EMBLEM S-ICD System is a compelling treatment option for the majority of ICD-indicated patients that provides protection from cardiac arrest without invading the heart and blood vessels.”
The EMBLEM MRI S-ICD System also includes two new features, SMART Pass technology and Atrial Fibrillation (AF) Monitor™. The SMART Pass technology will help ensure patients receive therapy from the device only when necessary by enhancing the INSIGHT™ Algorithm, which identifies and classifies a heart rhythm for effective arrhythmia treatment. This novel feature will also be added to previously implanted EMBLEM S-ICD Systems through a software update. The AF Monitor feature of the EMBLEM MRI S-ICD System is a new detection tool designed to alert physicians after the identification of AF so they can make more informed treatment decisions for their patients.