NeuroPace Removes Barrier for Epilepsy Treatment Through FDA Nod

NeuroPace is spicing up the neuromodulation market a bit with a new nod from FDA for MRI labeling for the RNS system. The Mountain View, CA-based company’s RNS System treats patients living with seizures that do not respond to medication and first landed a PMA in November of 2013. In a release, the company said individuals with focal onset seizures that also have brain anomalies that require monitoring, such as tuberous sclerosis, brain tumors or multiple sclerosis, as well as those with non-brain MRI requirements, can now be offered the RNS System as a treatment option. The company added this will also allow people to receive the RNS System before committing to an irreversible surgery such as laser ablation while keeping their future treatment options open. “MRI conditional labeling opens up valuable medical imaging possibilities for our patients treated with the model RNS-320 neurostimulator, who can now receive full-body 1.5T magnetic resonance imaging (MRI) scans under appropriate conditions,” Michael Favet, President and CEO of NeuroPace, said in a release. “I’m pleased that we have removed a potential barrier to treatment and increased the number of patients who can benefit from this life-changing therapy.” The RNS System is a closed-loop, brain-responsive neurostimulation system that was designed to prevent epileptic seizures by stopping them at the source. The d...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Regulatory and Compliance Source Type: news

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Publication date: Available online 4 June 2020Source: Obesity Research &Clinical PracticeAuthor(s): Diego Moriconi, Stefano Masi, Eleni Rebelos, Agostino Virdis, Maria Laura Manca, Salvatore De Marco, Stefano Taddei, Monica Nannipieri
Source: Obesity Research and Clinical Practice - Category: Eating Disorders & Weight Management Source Type: research
CONCLUSIONS: Due to the high incidence of the anatomical variants of the paranasal sinuses, aCT scan is recommended in all patients before a planned surgery in order to avoid the potential iatrogenic complications. Dimensions of the sphenoid sinuses might point towards more at risk variants, but there is still a substantial amount of research that needs to be done in that aspect. PMID: 32488857 [PubMed - as supplied by publisher]
Source: Folia Morphologica - Category: Anatomy Tags: Folia Morphol (Warsz) Source Type: research
Conclusions: There is a lack of convincing evidence to suggest that true inter-individual response differences exist with respect to aerobic exercise training and changes in fat mass and percent body fat in overweight and obese children and adolescents. PMID: 32486838 [PubMed - as supplied by publisher]
Source: Childhood Obesity - Category: Eating Disorders & Weight Management Tags: Child Obes Source Type: research
Conclusions: Child and family characteristics more strongly predicted initial engagement with a PWMC than completion. Future research should examine how targeting these predictors (e.g., referring at younger age) can improve PWMC engagement. PMID: 32484761 [PubMed - in process]
Source: Childhood Obesity - Category: Eating Disorders & Weight Management Tags: Child Obes Source Type: research
Conclusions: This study shows that BMI status may not be associated with childhood asthma control. Given the inconsistency in current evidence, more studies are needed in the future to investigate this association. PMID: 32484760 [PubMed - in process]
Source: Childhood Obesity - Category: Eating Disorders & Weight Management Tags: Child Obes Source Type: research
CONCLUSION: The results of this experiment suggest the possibility of swimming exercise in urological diseases that are difficult to treat. Swimming exercises can be considered for relief of symptom in incurable multiple sclerosis. PMID: 32482056 [PubMed]
Source: International Neurourology Journal - Category: Urology & Nephrology Tags: Int Neurourol J Source Type: research
This study was done to study the anthropometry of nonarthritic Asian knees; to determine the differences in morphology between knees of different ethnicities and to compare the knee anthropometry values with sizes of available knee implants. Methods: Magnetic resonance imaging scans of 100 nonarthritic Indian knees were analyzed. Anteroposterior (AP) length, mediolateral (ML) length, and aspect ratio of the distal femur and proximal tibia, patellar length, and patellar tendon length were measured. These values were compared with values of other ethnicities from literature. The values were also compared with sizes of av...
Source: Clinics in Orthopedic Surgery - Category: Orthopaedics Tags: Clin Orthop Surg Source Type: research
Authors: Park I, Oh MJ, Shin SJ Abstract For proper treatment of recurrent anterior instability of the shoulder with a bone defect, the defect size should be assessed preoperatively with three-dimensional computed tomography or magnetic resonance imaging. In general, the risk of postoperative recurrence of instability is estimated on the basis of preoperative imaging of bipolar bone defects: more than 20%-25% glenoid bone loss and off-track Hill-Sachs lesions have been considered risk factors for recurrence. In patients with a glenoid bone defect more than 20%-25%, a bone graft procedure, such as the Latarjet proce...
Source: Clinics in Orthopedic Surgery - Category: Orthopaedics Tags: Clin Orthop Surg Source Type: research
We present a case of severe vitD deficiency-osteomalacia after gastric bypass operation for morbid obesity, treated with ergocalciferol intramuscularly. A 45-year-old woman was presented with hip pain and muscle weakness, which led ultimately to immobilization in a wheelchair. Fifteen years ago, she underwent roux-en-Y gastric by-pass for morbid obesity. Occasionally, she was treated with multivitamin supplements. On admission, iron deficiency anaemia, vitD deficiency (25OHD: 3.7 ng/ml) and secondary hyperparathyroidism were revealed. Bone turnover markers (BTM) were elevated. Radiological evaluation demonstrated insuffici...
Source: Journal of Musculoskeletal Neuronal Interactions - Category: Neurology Tags: J Musculoskelet Neuronal Interact Source Type: research
Authors: Gurpinar B, Kara B, Idiman E Abstract OBJECTIVES: Postural control and hand dexterity are significantly impaired in people with multiple sclerosis (pwMS). Aquatic interventions may have additional benefits in the treatment of pwMS. The purpose of this study is to compare the effects of two different aquatic exercises on postural control and hand function. METHODS: Thirty pwMS, relapsing-remitting type were randomly divided into a Halliwick (Hallw) and an Aquatic Plyometric Exercise (APE) group. The Limits of Stability test was used to evaluate postural control using the Biodex Balance System. The Nine-...
Source: Journal of Musculoskeletal Neuronal Interactions - Category: Neurology Tags: J Musculoskelet Neuronal Interact Source Type: research
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