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.
Showing posts with label Magnetic Resonance Imaging. Show all posts
Showing posts with label Magnetic Resonance Imaging. Show all posts
16 August, 2016
26 July, 2016
New Superconducting Coil Improves MRI Performance
A multidisciplinary research team led by University of Houston scientist Jarek Wosik has developed a high-temperature superconducting coil that allows magnetic resonance imaging (MRI) scanners to produce higher resolution images or acquire images in a shorter time than when using conventional coils.
Wosik, a principal investigator at the Texas Center for Superconductivity at UH, said test results show the new technology can reveal brain structures that aren’t easily visualized with conventional MRI coils. He also is a research professor in the UH Department of Electrical and Computer Engineering.
The cryo-coil works by boosting the signal-to-noise ratio (SNR) – a measure of the strength of signals carrying useful information – by a factor of two to three, compared with conventional coils. SNR is critical to the successful implementation of high resolution and fast imaging.
Wosik said the cryo-coil reveals more details than a conventional coil because of its enhanced SNR profile. Where a conventional coil does not have enough sensitivity to “see,” a superconducting coil can still reveal details. These details will remain hidden to conventional coils even when image acquisition is repeated endlessly.
For the initial tests, the probe was optimized for rat brain imaging, useful for biomedical research involving neurological disorders. But it also has direct implications for human health care, Wosik said.
“Research in animal models yields critical information to improve diagnosis and treatment of human diseases and disorders,” he said. “This work also has the potential to clearly benefit clinical MRI, both through high quality imaging and through shortening the time patients are in the scanner.”
Results from preliminary testing of the 7 Tesla MRI Cryo-probe were presented at the International Symposium of Magnetic Resonance in Medicine annual meeting in May. The coil can be optimized for experiments on living animals or brain tissue samples, and researchers said they demonstrated an isotropic resolution of 34 micron in rat brain imaging. In addition to its use in MRI coils, superconductivity lies at the heart of MRI scanning systems, as most high-field magnets are based on superconducting wire.
In addition to Wosik, collaborators on the project include Ponnada A. Narayana, director of the Magnetic Resonance Imaging Center and a professor in the Department of Diagnostic and Interventional Imaging at the University of Texas Health Science Center at Houston; Kurt H. Bockhorst, senior research scientist at UT Houston; Kuang Qin, a graduate student working with Wosik; and I-Chih Tan, assistant professor in the Department of Neuroscience at Baylor College of Medicine.
Compared to corresponding standard room temperature MRI coils, the performance of the cooled normal metal and/or the high-temperature superconducting receiver coils lead either to an increase in imaging resolution and its quality, or to a very significant reduction in total scan time,” Wosik said.
Wosik, a principal investigator at the Texas Center for Superconductivity at UH, said test results show the new technology can reveal brain structures that aren’t easily visualized with conventional MRI coils. He also is a research professor in the UH Department of Electrical and Computer Engineering.
The cryo-coil works by boosting the signal-to-noise ratio (SNR) – a measure of the strength of signals carrying useful information – by a factor of two to three, compared with conventional coils. SNR is critical to the successful implementation of high resolution and fast imaging.
Wosik said the cryo-coil reveals more details than a conventional coil because of its enhanced SNR profile. Where a conventional coil does not have enough sensitivity to “see,” a superconducting coil can still reveal details. These details will remain hidden to conventional coils even when image acquisition is repeated endlessly.
For the initial tests, the probe was optimized for rat brain imaging, useful for biomedical research involving neurological disorders. But it also has direct implications for human health care, Wosik said.
“Research in animal models yields critical information to improve diagnosis and treatment of human diseases and disorders,” he said. “This work also has the potential to clearly benefit clinical MRI, both through high quality imaging and through shortening the time patients are in the scanner.”
Results from preliminary testing of the 7 Tesla MRI Cryo-probe were presented at the International Symposium of Magnetic Resonance in Medicine annual meeting in May. The coil can be optimized for experiments on living animals or brain tissue samples, and researchers said they demonstrated an isotropic resolution of 34 micron in rat brain imaging. In addition to its use in MRI coils, superconductivity lies at the heart of MRI scanning systems, as most high-field magnets are based on superconducting wire.
In addition to Wosik, collaborators on the project include Ponnada A. Narayana, director of the Magnetic Resonance Imaging Center and a professor in the Department of Diagnostic and Interventional Imaging at the University of Texas Health Science Center at Houston; Kurt H. Bockhorst, senior research scientist at UT Houston; Kuang Qin, a graduate student working with Wosik; and I-Chih Tan, assistant professor in the Department of Neuroscience at Baylor College of Medicine.
Compared to corresponding standard room temperature MRI coils, the performance of the cooled normal metal and/or the high-temperature superconducting receiver coils lead either to an increase in imaging resolution and its quality, or to a very significant reduction in total scan time,” Wosik said.
More information can be found from University of Houston website by following this link.
18 July, 2016
FDA approves exablate neuro system for essential tremor treatment
Insightec announced that the FDA has approved its Exablate Neuro system for the non-invasive treatment of essential tremor (ET) in patients who have not responded to medication.
Exablate Neuro uses focused ultrasound waves to precisely target and ablate tissue deep within the brain with no incisions or implants. The treatment is done under Magnetic Resonance Imaging (MRI) guidance for real time treatment monitoring. The patient experiences immediate tremor improvement following the outpatient procedure. The treatment carries minimal risk of infection, bleeding or other surgical complications. The treatment requires a single session with no anesthesia, allowing patients to quickly return to normal activity.
Essential tremor is the most common movement disorder, affecting more than 5 million people in the United States, and millions more worldwide. Hand tremor is the most common symptom, but tremors can also affect the head, arms, voice, legs, and torso. For these patients, performing everyday tasks presents a challenge and impacts their quality of life.
This approval by the FDA was based on clinical data from a randomized, double-blind, multi-center clinical study designed to evaluate the safety and efficacy of non-invasive thalamotomy with MRgFUS. A total of 76 patients were enrolled in the study and randomly assigned to receive the Exablate treatment (56 patients) or the sham procedure (20 patients), the exact same procedure but without any ultrasound energy. Patients in the placebo treatment arm were later allowed to undergo an Exablate Neuro treatment. Patients treated with the Exablate Neuro showed nearly a 50% improvement in their tremors and motor function three months after treatment compared to their baseline score. Patients in the control group had no improvement, and some experienced a slight worsening after the sham procedure before they crossed over into the treatment group. A year following the procedure, the patients who underwent the Exablate Neuro procedure retained a 40% improvement in these scores compared to baseline.
“Results of this study show that Exablate Neuro is safe and effective for treating essential tremor. Finding the most effective way to manage tremor symptoms is crucial for patients. The patients we have treated show immediate tremor control, allowing them to regain ability to perform daily tasks such as eating and writing,” commented Dr. W. Jeffrey Elias, Director of Stereotactic and Functional Neurosurgery at the University of Virginia and Principal Investigator in the study.
Earlier this year, Exablate was also approved by Health Canada for essential tremor.
“This newly FDA approved device provides a new treatment option without some of the complications associated with surgery to offer patients with essential tremor. Furthermore, it holds promise for a range of neurosurgical procedures,” noted Andres Lozano, MD, Dan Family Professor and Chairman of Neurosurgery at Toronto Western Hospital, University of Toronto and Investigator in the study.
“I am confident that we have arrived at a tipping point for non-invasive medical treatment. Focused ultrasound has the unique ability to precisely ablate target tissue deep within the body. With Exablate Neuro, INSIGHTEC expands its Exablate product line with a system that signifies a new era for functional neurosurgery,” stated Maurice R. Ferré MD, INSIGHTEC Chief Executive Officer and Chairman of the Board.
Exablate Neuro also has CE mark for essential tremor, tremor dominant Parkinson’s disease and neuropathic pain.
Exablate Neuro uses focused ultrasound waves to precisely target and ablate tissue deep within the brain with no incisions or implants. The treatment is done under Magnetic Resonance Imaging (MRI) guidance for real time treatment monitoring. The patient experiences immediate tremor improvement following the outpatient procedure. The treatment carries minimal risk of infection, bleeding or other surgical complications. The treatment requires a single session with no anesthesia, allowing patients to quickly return to normal activity.
Essential tremor is the most common movement disorder, affecting more than 5 million people in the United States, and millions more worldwide. Hand tremor is the most common symptom, but tremors can also affect the head, arms, voice, legs, and torso. For these patients, performing everyday tasks presents a challenge and impacts their quality of life.
This approval by the FDA was based on clinical data from a randomized, double-blind, multi-center clinical study designed to evaluate the safety and efficacy of non-invasive thalamotomy with MRgFUS. A total of 76 patients were enrolled in the study and randomly assigned to receive the Exablate treatment (56 patients) or the sham procedure (20 patients), the exact same procedure but without any ultrasound energy. Patients in the placebo treatment arm were later allowed to undergo an Exablate Neuro treatment. Patients treated with the Exablate Neuro showed nearly a 50% improvement in their tremors and motor function three months after treatment compared to their baseline score. Patients in the control group had no improvement, and some experienced a slight worsening after the sham procedure before they crossed over into the treatment group. A year following the procedure, the patients who underwent the Exablate Neuro procedure retained a 40% improvement in these scores compared to baseline.
“Results of this study show that Exablate Neuro is safe and effective for treating essential tremor. Finding the most effective way to manage tremor symptoms is crucial for patients. The patients we have treated show immediate tremor control, allowing them to regain ability to perform daily tasks such as eating and writing,” commented Dr. W. Jeffrey Elias, Director of Stereotactic and Functional Neurosurgery at the University of Virginia and Principal Investigator in the study.
Earlier this year, Exablate was also approved by Health Canada for essential tremor.
“This newly FDA approved device provides a new treatment option without some of the complications associated with surgery to offer patients with essential tremor. Furthermore, it holds promise for a range of neurosurgical procedures,” noted Andres Lozano, MD, Dan Family Professor and Chairman of Neurosurgery at Toronto Western Hospital, University of Toronto and Investigator in the study.
“I am confident that we have arrived at a tipping point for non-invasive medical treatment. Focused ultrasound has the unique ability to precisely ablate target tissue deep within the body. With Exablate Neuro, INSIGHTEC expands its Exablate product line with a system that signifies a new era for functional neurosurgery,” stated Maurice R. Ferré MD, INSIGHTEC Chief Executive Officer and Chairman of the Board.
Exablate Neuro also has CE mark for essential tremor, tremor dominant Parkinson’s disease and neuropathic pain.
A press release can be found from Insightec website.
20 May, 2016
FDA Approves MR Conditional Tachycardia Devices from Biotronik
Biotronik announced Food and Drug Administration (FDA) approval of Iperia ProMRI HF-T, a cardiac resynchronization defibrillator that provides heart failure patients with access to diagnostic magnetic resonance imaging (MRI) scans. Iperia devices also have remote monitoring with daily automatic transmission and closed loop stimulation (CLS) that adapts the heart rate in response to physiological demands.
Iperia HF-T was developed with BIOTRONIK’s ProMRI, Home Monitoring, and CLS technology, creating an advanced cardiac resynchronization therapy defibrillator (CRT-D) designed to support each patient’s unique healthcare journey. BIOTRONIK’s MR conditional tachycardia devices ensure patients have access to 1.5T scans without an exclusion zone. Home Monitoring provides automatic daily transmission of data relating to arrhythmic events and heart failure statistics, which have been shown to reduce all-cause mortality by more than 50 percent. For heart failure patients, early detection of deterioration reduces patient mortality.
“The FDA approval of Iperia HF-T demonstrates the shift that is happening in cardiovascular patient care,” said Marlou Janssen, President, BIOTRONIK, Inc. “BIOTRONIK now offers a comprehensive portfolio of MR conditional ICDs. We’re driving the standard of care to new levels by providing physicians and hospitals with innovative, reliable, cardiac devices that ensure patients have access to imaging technology critical to diagnosing and treating future illness and injury. This is technology that is making a difference in patients’ lives.”
“The FDA approval of Iperia HF-T demonstrates the shift that is happening in cardiovascular patient care,” said Marlou Janssen, President, BIOTRONIK, Inc. “BIOTRONIK now offers a comprehensive portfolio of MR conditional ICDs. We’re driving the standard of care to new levels by providing physicians and hospitals with innovative, reliable, cardiac devices that ensure patients have access to imaging technology critical to diagnosing and treating future illness and injury. This is technology that is making a difference in patients’ lives.”
A press release can be found by following this link.
19 May, 2016
FDA Approves MRI Spinal Cord Stimulator from Boston Scientific
Boston Scientific announced the launch of the Precision Montage MRI Spinal Cord Stimulator (SCS) System after receiving approval from the U.S. Food and Drug Administration. The Precision Montage System offers customized relief to patients with chronic pain while also enabling safe access to full body magnetic resonance imaging (MRI) in a 1.5 Tesla environment when conditions of use are met.
More than 100 million Americans suffer from chronic pain, which can have a devastating impact on quality of life. Patients with pain sometimes experience a fluctuation in location, type and intensity of pain throughout the day or over time. The Precision Montage MRI SCS System allows patients to undergo a full-body MRI while benefiting from the pain relief of MultiWave Technology. MultiWave Technology enables delivery of multiple waveforms, including burst and higher rates, intended to help respond to changes in pain over time. In an analysis of registry information from 800 patients, it was determined that 72 percent used multiple waveforms to customize their therapy and optimize pain relief.
A press release can be found from Boston Scientific website by following this link.
A press release can be found from Boston Scientific website by following this link.
14 April, 2016
BIOTRONIK Receives FDA Approval of Insertable Cardiac Monitor
Biotronik announced Food and Drug Administration (FDA) approval of BioMonitor 2, an insertable cardiac remote monitor with ProMRI® technology.
BioMonitor 2 is designed to provide physicians with the ability to accurately detect and diagnose atrial fibrillation, ventricular tachycardia and fibrillation, and syncope. The device can also be used to monitor atrial events in patients who have undergone ablation procedures.
BioMonitor 2 is inserted subcutaneously through a minimally invasive process under local anesthesia. The device provides a flexible antenna and positioning, adapting easily to a patient’s anatomy, while providing unmatched sensing amplitude that ensures reporting accuracy. BioMonitor 2 also features BIOTRONIK’s ProMRI technology, ensuring patients have access to full-body magnetic resonance imaging (MRI) scans (both 1.5T and 3.0T) as needed throughout their lifetime.BioMonitor 2 is designed to provide physicians with the ability to accurately detect and diagnose atrial fibrillation, ventricular tachycardia and fibrillation, and syncope. The device can also be used to monitor atrial events in patients who have undergone ablation procedures.
More info can be found from Biotronik website by clicking this link.
Subscribe to:
Posts (Atom)