Medicare Will Pay For MRIs When Patient Has Pacemaker

The Centers for Medicare & Medicaid Services (CMS) has expanded coverage to include MRI for beneficiaries with implanted pacemakers when used according to FDA-approved labeling in an MRI environment.

A final National Coverage Determination posted today provides access to the MRI environment for patients with FDA-approved pacemakers.

On February 8, the FDA approved the RevoMRI SureScan Pacing System, which is designed for use in the MRI environment for certain MRI exams.  Currently, there are no other pacemakers or implantable cardioverter defibrillators that are FDA-approved for use in the MRI environment.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm242651.htm
http://www.medtronic.com/for-healthcare-professionals/products-therapies/cardiac-rhythm/pacemakers/revo-mri-pacing-system/index.htm

 

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SurgiVision MRI-Compatible SmartFlow Cannula Receives FDA Clearance


SurgiVision has received FDA clearance for its MRI-Compatible SmartFlow Cannula, for use with the previously covered ClearPoint system (pictured above).
From the press release:

The SmartFlow cannula is an MRI-compatible injection and aspiration cannula for use in the brain. The SmartFlow cannula is compatible with SurgiVision’s ClearPoint® system. Using the new SmartFlow cannula with the ClearPoint system, neurosurgeons can select a neurological target, navigate the SmartFlow cannula to the target and observe the delivery of the therapeutic agent, all under intra-procedural MRI guidance. Other features of the SmartFlow cannula include a multi-step tip design to help prevent reflux along the cannula shaft.
“The medical community is continuing to find therapeutic agents that hold great promise in treating various CNS disorders, however many of these agents will require precision delivery, direct into a small neuro target,” said Kimble Jenkins, CEO of SurgiVision. “It is our hope that SurgiVision’s expanding range of products in interventional MRI could help fill this need and lead to better therapies for patients.”

 

CLEARPOINT®
NEURO INTERVENTION
SYSTEM
An integrated system of reusable components, disposable devices and intuitive, menu-driven software for MRI-guided neurological procedures

SELECTED COMPONENTS OF THE CLEARPOINT® SYSTEM:

SmartFrame® Device — Disposable, MRI-compatible head-mounted adjustable trajectory frame with disposable physician controller

 

At the same time, SurgiVision has also announced a collaboration with Brainlab, to bring the ClearPoint product line to that company’s iMRI interventional MRI suite. Aim of that collaboration is to enable local delivery of drugs and other therapeutic agents to precision targets in the brain under MRI guidance, in brain disorders such as Parkinson disease and malignant brain tumors.
Press releases: SurgiVision MRI-Compatible SmartFlow Cannula Receives FDA Clearance…,Brainlab and SurgiVision Announce Strategic Alliance in MRI-guided Drug Delivery and Other Interventional MRI Technologies in Neurosurgery…

 

 

 

 

 

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NovoTTF-100A for Treatment of Brain Tumors Wins FDA Clearance

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NovoTTF-100A, a device for treatment of glioblastoma multiforme from Novocure, a subsidiary of Jersey Isle-based Standen Ltd., received FDA approval following a clinical trial and an agency panel recommendation. The device creates an electric field at the tumor site, preventing cancer cells from dividing and the tumor from growing. The system is indicated for patients following tumor recurrence after receiving chemotherapy.
From the announcement:

NovoTTF-100A is a portable, non-invasive medical device designed for continuous use throughout the day by the patient. The device has been shown in in vitro studies to slow and reverse tumor growth by inhibiting mitosis, the process by which cells divide and replicate. The NovoTTF-100A device, which weighs about six pounds (three kilograms), creates a low intensity, alternating electric field within the tumor that exerts physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death prior to division. Novocure currently has U.S. and European marketing approvals for the NovoTTF-100A.

 

Press releaseFDA Approves the NovoTTF-100A System for the Treatment of Patients With Recurrent Glioblastoma Multiforme (GBM) Brain Tumors
LinkNovocure homepage…

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Specialties Emerge among MR Technologists

Magnetic resonance (MR) technologists have developed three de-facto specialties over time, which could herald new training programs to meet the community’s needs.

Advancements in the medical sciences, imaging technology, and magnetic resonance clinical applications have driven the emerging specialties, said Michael L. Grey, PhD, a radiation technologist and associate professor at Southern Illinois University in Carbondale and author of the study published in the July/August 2011 issue ofRadiologic Technology, a journal of the American Society of Radiologic Technologists.

Grey examined the results of an MR practice analysis questionnaire distributed to a random sample of registered MR technologists by the American Registry of Radiologic Technologists. Participants were asked to describe the type and frequency of procedures they performed.

He analyzed 78 MR tasks outlined in the survey results and found four imaging task groups that were consistently used in MR practice. Out of the four areas, three MR specialty areas emerged: vascular/cardiovascular imaging, central nervous system imaging and musculoskeletal imaging.

“When I was doing the study, I noticed that there were commonalities in each factor,” said Grey. “As I dug deeper, I discovered that MR specialty areas have developed over time.”

As new MR applications are developed, education and training programs will be needed to meet the demands of the imaging community, he added.

The results point to the need for the American Registry of Radiation Technologists (ARRT) to consider developing advanced specialty certification examinations to provide opportunities to the technologists operating MR units in the new specialty areas, he said.

But training is the first priority, Grey said, adding that “formal education and training protocols should be in place before technologists take the MR Registry exam so they are prepared to effectively practice in the area.”

 

Those of us who have been in the field for more than 15 years would agree with Dr. Grey’s findings. Although formal education and training will be necessary for specialty certification; I feel we need to look forward and see how technology can assist us to be more efficient. Technologists with specialty skills are able to perform without having to be at the specific site. Remote access and Cloud protocol access that eliminates OS compatibility can allow patients to visit the nearest Imaging facility, which has the hardware capabilities, and imaged. Having access to a registered technologist (MR registry certified) allows the patient flexibility where to go, the facility does not need to concern themselves if the onsite technologist is competent to perform the exam so that the quality of the exam will not be compromised. Such efficiency will also keep health care cost down.

Charles Deschamps

http://www.diagnosticimaging.com/mri/content/article/113619/1908979

 

 

This is where Technology is going.  The ability of remote scanning from across town or across the ocean. We are headed for a new generation of exciting advancements we have yet to comprehend. How we use these tools will be the fun part. I can’t wait to get my hands on them.

Coolmristuff

 

 

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CaseoftheWeek @ DiagnosticImaging.com & Rad rounds

 

 

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MRI detection of tissue pathology beyond atrophy in Alzheimer’s disease: Introducing T2-VBM

Abstract

Voxel-based morphometry (VBM) of T1-weighted magnetic resonance (MR) images has been widely used to identify regional atrophy in neurodegenerative conditions such as Alzheimer’s disease (AD). In theory, however, T2-weighting should be more sensitive to tissue pathology, though until recently, volumetric T2-weighted images were unavailable. We tested the hypothesis that T2-VBM would be more sensitive to grey matter pathology in AD than T1-VBM using the recently-developed SPACE acquisition, which provides true-3D, high-resolution T2-weighted images. This was contrasted to conventional T1-weighted MPRAGE images acquired at the same session and resolution. All of the atrophic regions identified with T1-VBM were also identified with T2-VBM. Additional abnormalities were, however, identified with T2-VBM and the distribution of these bore a striking resemblance to the distribution of amyloid plaque deposition in AD, suggesting that T2-VBM detects signal changes due to histopathology over and above those attributable to atrophy. In keeping with this hypothesis, the relevant statistical tests demonstrated that the difference in sensitivity was caused by an apparent change in T2-weighted signal intensity that was not present in T1-weighted images. These results suggest that T2-VBM has the potential to advance VBM beyond atrophy detection to more expansive applications in tissue pathology mapping.

Research highlights

► T2-VBM could be more sensitive to grey matter pathology in AD than T1-VBM. ► All of the atrophic regions identified with T1-VBM, were identified with T2-VBM. ► T2-VBM found additional lesions, possibly consistent with the distribution of amyloid. ► T2-VBM not only identifies atrophy but also likely other pathology.

Keywords: Alzheimer’s disease; Voxel-based morphometry; T2-weighting; Amyloid; Grey matter pathology

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Abstract 
Introduction In the UK small bowel follow-through (SBFT) is the current standard for investigating small bowel Crohn’s disease. However advances in small bowel MRI (SB-MRI) mean that it is now a viable alternative with the advantage of no ionizing radiation and the potential ability to differentiate active from inactive disease and identify extra-intestinal pathology. We therefore wished to analyse the clinical utility of SB-MRI in the investigation of small bowel Crohn’s disease, and correlate the findings with SBFT, ileo-colonoscopy and inflammatory markers.

Methods Data was prospectively collected on 100 sequential patients with small bowel Crohn’s disease who underwent SB-MRI over the last year. 48 patients also underwent parallel SBFT, 53 parallel ileo-colonoscopy and 80 patients had inflammatory markers measured. Results from the 3 groups were compared.

Results SB-MRI and SBFT were equally effective in identifying the presence or absence of small bowel Crohn’s disease. However SB-MRI was more accurate in the identification of strictures and allowed more precise localisation. In addition MRI was able to differentiate active from inactive disease, identify extra-intestinal pathology and provide information on colonic involvement. SB-MRI estimation of disease activity correlated well with both endoscopic and histological findings, with 93% of patients correctly identified as having either active or quiescent disease. Inflammatory markers correlated poorly with MRI, endoscopic and histological findings with 46% of patients with active disease by any modality having a normal CRP or ESR.

Conclusion SB- MRI is superior to SBFT in the investigation of small bowel Crohn’s disease as in addition to identifying structural disease it provides information on stricture location, disease activity, colonic involvement and extra-intestinal pathology without exposing patients to ionising radiation. We believe that SB-MRI should now replace SBFT as the investigation of choice for small bowel Crohn’s disease.

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