Alcyone Lifesciences wins FDA nod for Alivio hydrocephalus shunt flusher
Alcyone Lifesciences said yesterday it won FDA 510(k) clearance for its Alivio ventricular catheter and flusher system designed for treating hydrocephalus. The newly cleared Alivio device is designed for the non-invasive retrograde flushing of the ventricular catheter to unblock occluded inlet holes or open a relief membrane to restore or increase cerebrospinal fluid flow in non-flowing shunts, the Lowell, Mass.-based company said. “For the first time in over half a century there has been a game changing improvement in the field of hydrocephalus treatment. Ventricular shunting can help save lives and improve th...
Source: Mass Device - November 16, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Neurological Regulatory/Compliance Alcyone Lifesciences Source Type: news
7 medtech stories we missed this week: Oct. 27, 2017
[Image from unsplash.com]From RadiaDyne’s FDA expansion to NuVasive launching its new implants, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA expands indications for RadiaDyne’s OARtrac dose monitor RadiaDyne announced in an Oct. 24 press release that it has received additional FDA clearance for its upcoming OARtrac. The OARtrac allows physicians to routinely monitor brachytherapy radiation dose as well as being able to reuse the OARtrac Plastic Scintillating Detector sensor cable no more than five times on one patient. 2. FDA clears Ortek’s e...
Source: Mass Device - October 27, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Catheters Dental Diagnostics Food & Drug Administration (FDA) Imaging Implants Neurological Research & Development Alcyone Lifesciences Implanet MedTech Nuvasive Ortek Therapeutics radiadyne Tau Consortium Varian Medical Syst Source Type: news
What Clinical Signs Can Be Associated With Benign External Hydrocephalus?
Discussion Hydrocephalus is an abnormal accumulation of cerebrospinal fluid (CSF) in the ventricles and/or subarachnoid spaces. External hydrocephalus is a communicating hydrocephalus often defined as the patient having a rapidly enlarging head circumference (HC) and enlargement of the subarachnoid spaces especially over the frontal lobes with normal or moderately enlarged ventricles. Benign external hydrocephalus (BEH) is a self-limited external hydrocephalus that occurs during infancy and resolves spontaneously in childhood, usually by age 2 years, that is felt to not cause significant problems. It was first described by...
Source: PediatricEducation.org - October 2, 2017 Category: Pediatrics Authors: pediatriceducationmin Tags: Uncategorized Source Type: news
MassDevice.com +5 | The top 5 medtech stories for April 20, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters. 5. NuVasive launches Reline Trauma posterior fixation portfolio NuVasive Inc. said yesterday it launched its Reline Trauma spinal posterior fixation portfolio designed to aid in the preservation and restoration of patient alignmen...
Source: Mass Device - April 20, 2017 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Arkis BioSciences Expands Clinical Use Of Its New Minimally Invasive Tunneling Guidewire(TM) Technology
Single Pass Shunt Workflow enables up to one-third less invasive Shunt Procedures in Hydrocephalus Patients KNOXVILLE, Tenn., April 20, 2017 -- (Healthcare Sales & Marketing Network) -- Arkis BioSciences, a leading innovator in minimally invasive surg... Devices, Neurosurgery, Product Launch Arkis BioSciences, Single Pass, Tunneling Guidewire, intracranial pressure (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 20, 2017 Category: Pharmaceuticals Source Type: news
FDA labels Medtronic StrataMR recall as Class I
The FDA today released updated information on Medtronic‘s (NYSE:MDT) recall of StrataMR adjustable valves and shunts over issues with fluid buildup, labeling it as Class I. The StrataMR adjustable valves and shunts are intended for the management of hydrocephalus by providing cerebrospinal fluid flow from the ventricles of the brain into the right atrium of the heart or peritoneal cavity. The recall relates to issues with flow resistance that could lead to under-drainage of cerebrospinal fluid, arising when the valve mechanism is adjusted to a position which causes higher-than-intended flow r...
Source: Mass Device - April 20, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Neurological Recalls Medtronic Source Type: news
Medtronic Recalls All StrataMR Valves, Shunts for Hydrocephalus Medtronic Recalls All StrataMR Valves, Shunts for Hydrocephalus
The recall is based on the potential for under-drainage of cerebrospinal fluid after the StrataMR valves and shunts are implanted, the company said.News Alerts (Source: Medscape Neurology and Neurosurgery Headlines)
Source: Medscape Neurology and Neurosurgery Headlines - April 10, 2017 Category: Neurology Tags: Neurology & Neurosurgery News Alert Source Type: news
Medtronic Announces Voluntary Worldwide Recall of its StrataMR(TM) Adjustable Valves and Shunts
DUBLIN - April 6, 2017 -- (Healthcare Sales & Marketing Network) -- Medtronic plc (NYSE: MDT) today announced that on February 22, 2017 it notified customers of a voluntary recall of all unused units of the StrataMR(TM) adjustable valves and shunts. These ... Devices, Neurosurgery, Product Recall Medtronic, StrataMR, intracranial pressure, hydrocephalus (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 7, 2017 Category: Pharmaceuticals Source Type: news
Ventricular Enlargement Plus Idiopathic NPH Symptoms May Up Risk for Dementia Ventricular Enlargement Plus Idiopathic NPH Symptoms May Up Risk for Dementia
Enlarged ventricles in the brain plus one symptom of idiopathic normal-pressure hydrocephalus is associated with an increase in all-cause dementia, even after initially successful shunt surgery, say researchers.Medscape Medical News (Source: Medscape Neurology and Neurosurgery Headlines)
Source: Medscape Neurology and Neurosurgery Headlines - April 6, 2017 Category: Neurology Tags: Neurology & Neurosurgery News Source Type: news
Evaluation of the use of human umbilical cord for in-utero spina bifida repair
Spina Bifida is a birth defect where there is an incomplete closure of the backbone and the coverings around the spinal cord. It affects more than 4,000 children born each year in the United States and is associated with hydrocephalus (fluid in the brain), developmental delay, lifelong disability and death. Spina Bifida is also associated with a need for shunt placement. In-utero surgery has been shown to reduce the need for shunting of hydrocephalus and to improve a child's ability to walk. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - January 23, 2017 Category: Science Source Type: news
Predicting Shunt Outcome in Obstructive Hydrocephalus Predicting Shunt Outcome in Obstructive Hydrocephalus
Are preoperative radiological findings in pediatric patients with obstructive hydrocephalus useful for predicting overall outcome following shunt insertion?Neurosurgical Focus (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - December 30, 2016 Category: Consumer Health News Tags: Neurology & Neurosurgery Journal Article Source Type: news
Make the Diagnosis: Cerebrospinal Fluid Color Challenge
(MedPage Today) -- Case Findings: A 3-year-old boy with a brain stem glioma develops hydrocephalus and is treated with a ventriculoperitoneal shunt. He presents with green cerebrospinal fluid. What is your diagnosis? (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - December 19, 2016 Category: American Health Source Type: news
Alcyone Lifesciences seeks FDA nod for ReFlow neuro cath
Alcyone Lifesciences is seeking formal commercial approval for its device to treat fluid buildup in the brain, following its successful implant in 4 patients in an ongoing study at Boston Children’s Hospital. The Lowell, Mass.-based company said that its decision to file a 510(k) premarket notification with the FDA seeking a regulatory sign-off for its ReFlow System also comes after the successful completion of a number of bench and animal studies. Alcyone wants to treat a condition known as hydrocephalus, where there is an excessive buildup of cerebrospinal fluid. As the company explains, this can threaten a pa...
Source: Mass Device - August 2, 2016 Category: Medical Equipment Authors: Mark Hollmer Tags: Catheters Food & Drug Administration (FDA) Neurological Regulatory/Compliance Alcyone Lifesciences Source Type: news
Staying ontop of hydrocephalus shunt failure with ShuntCheck
Antonio Venus-Reeve, 14, had his first shunt surgery for hydrocephalus when he was 2½ months old. Born at 25 weeks’ gestation, weighing less than two pounds, he had a serious brain bleed seven days later. As Antonio’s head began to swell with excess fluid, neurologists at Boston Children’s Hospital told his mother, Joanne Venus-Williams, that Antonio probably would not be able to walk, talk or develop major motor skills. “Neurosurgery got involved and the team did daily spinal taps to draw out the fluid in his brain,” says Venus-Williams. “They were hoping he wouldn’t need ...
Source: Mass Device - June 7, 2016 Category: Medical Equipment Authors: MassDevice Tags: Blog Vector Blog Source Type: news
Medtronic Expands MRI-Compatible Portfolio With FDA Clearance Of StrataMR™ Shunt System
Medtronic plc recently announced the U.S. Food and Drug Administration (FDA) clearance of StrataMR valves and shunts, an addition to Medtronic's family of Strata Adjustable Valve Systems used in the treatment of patients with hydrocephalus and cerebrospinal fluid (CSF) disorders. (Source: Medical Design Online News)
Source: Medical Design Online News - May 3, 2016 Category: Medical Equipment Source Type: news
MassDevice.com +5 | The top 5 medtech stories for May 2, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters. 5. Dexcom slides on Q1 earnings miss despite sales beat Dexcom shares have slipped nearly 6% since the continuous glucose monitoring company released its 1st-quarter results April 27 after the company missed Wall Street’s ea...
Source: Mass Device - May 2, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Medtronic wins FDA clearance for StrataMR valves
Medtronic (NYSE:MDT) today said it won FDA clearance for its StrataMR valves and shunts for patients with hydrocephalus and cerebrospinal fluid conditions. The clearance allows the valves and shunts to be used during MRI scans at their performance level setting at up to 3.0 Tesla, Fridley, Minn.-based Medtronic said. StrataMR is slated to be available “in the coming months,” the company said. “Patients with hydrocephalus and CSF disorders often require MRI,” CSF management director Tom Poss said in prepared remarks. “The use of MRI has become a diagnostic standard of care, ...
Source: Mass Device - May 2, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Imaging Neurological Medtronic Source Type: news
Effects of prenatal myelomeningocele closure on the need for a CSF shunt
(Journal of Neurosurgery Publishing Group) Investigators reaffirm the initial MOMS finding that prenatal repair of a myelomeningocele results in less need for a shunt at 12 months and introduce the new finding that prenatal repair reduces the need for shunt revision in those infants who do require shunt placement. The researchers also found that patients with extensive hydrocephalus at the time of the prenatal evaluation did not show improved outcomes following prenatal surgery. (Source: EurekAlert! - Biology)
Source: EurekAlert! - Biology - September 15, 2015 Category: Biology Source Type: news
Medical, magnetic millirobots offer hope for less-invasive surgeries
Seeking to advance minimally invasive medical treatments, researchers have proposed using tiny robots, driven by magnetic potential energy from magnetic resonance imaging scanners. The potential technology could be used to treat hydrocephalus and other conditions, allowing surgeons to avoid current treatments that require cutting through the skull to implant pressure-relieving shunts, the researchers say. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - May 27, 2015 Category: Science Source Type: news
Preemie Jace Perkins rocks ’n rolls through 137 days in the NICU
Melyssa Perkins was 25 weeks into a healthy pregnancy with her first child when she began to have abdominal pain. She called her local nurse who said she was probably dehydrated, but when water didn’t help and the pain increased, Melyssa and her husband Jamie rushed to nearby Beverly Hospital, where they discovered that she was fully dilated. “I don’t think I said one word at that point. I was in complete shock,” recalls Melyssa. Two hours after the couple arrived at the hospital, their son Jace was born at 1lb. 12 oz. Beverly Hospital stabilized Jace and arranged for immediate transport to the Neon...
Source: Thrive, Children's Hospital Boston - March 31, 2015 Category: Pediatrics Authors: Jenny Fernandez Tags: Heart conditions Our patients’ stories Amblyopia Beverly Hospital Hydrocephalus IVF NICU patent ductus arteriosus Preemies’ Warf Source Type: news
A second chance for a baby with a life-threatening brain cyst
Photo courtesy of Jennifer Hammond Other than being born a little early—at 37 weeks—everything started out fine for Liam Hammond. “He was a healthy baby, it was a healthy birth, and he was progressing and meeting his milestones,” says his mother Jennifer. But at his 4-month-old check-up, “Something about his head looked different to me.” Liam’s head circumference was normal, though, and he was in the same head-growth percentile as at his last visit. The pediatrician suggested Jennifer keep watching it. Two weeks later, the family left for a seaside Memorial Day weekend vacation. &l...
Source: Thrive, Children's Hospital Boston - February 5, 2015 Category: Pediatrics Authors: Nancy Fliesler Tags: Our patients’ stories Hydrocephalus Source Type: news
Cereberal Spinal Fluid (CSF) Shunt Systems
Placement of cerebral spinal fluid (CSF) shunt systems to treat hydrocephalus is a common medical procedure and a life-saving treatment for many patients. These shunt systems drain excess fluid from the brain to another part of the body where the fluid... (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 20, 2014 Category: Medical Equipment Source Type: news
Global connections: Khalid’s story
When faced with a sick child, every parent in the world wants the same thing—the best care possible. Often, all it takes is a quick visit with the local health care provider. Occasionally, it means a trip to the local hospital or short stay at an academic medical center. In rare cases, obtaining the best care requires an extraordinary effort. A mother finds herself researching the world’s best pediatric neurosurgeons. An uncle turns to YouTube to learn more about brain tumors. Physicians on opposite corners of the globe find ways to communicate and collaborate. And a family boards an air ambulance, embarking on...
Source: Thrive, Children's Hospital Boston - February 10, 2014 Category: Pediatrics Authors: Lisa Fratt Tags: All posts Global health Brain tumor neurosurgery Source Type: news
What Boston Children’s families are thankful for
Happy Thanksgiving! We recently asked our patient families what they were most thankful for this year, and the responses we received were heartfelt and beautiful. However you spend this special week—celebrating Thanksgiving, Hanukkah or both—we hope you’re able to find a few moments of peace for yourself and your family, and together enjoy the things that you’re thankful for. I’m thankful for the cardiac team that kept my baby healthy before and after her emergency Tetralogy of Fallot repair this month! Could not have asked for better caregivers for my baby girl! ___________________________ ...
Source: Thrive, Children's Hospital Boston - November 27, 2013 Category: Pediatrics Authors: Tripp Underwood Tags: All posts our patients' stories Parenting thanksgiving with family thanksgving and illness Source Type: news
Generation of a Central Nervous System Catheter-Associated Infection in Mice with Staphylococcus epidermidis
Animal models are valuable tools for investigating the in vivo pathogenesis of Staphylococcus epidermidis infections. Here, we present the procedure for generating a central nervous system catheter-associated infection in a mouse, to model the central nervous system shunt infections that frequently complicate the treatment of hydrocephalus in humans. This model uses stereotactic guidance to place silicone catheters, pre-coated with S. epidermidis, into the lateral ventricles of mice. This results in a catheter-associated infection in the brain, with concomitant illness and inflammation. This animal model is a valuable tool...
Source: Springer protocols feed by Infectious Diseases - November 18, 2013 Category: Infectious Diseases Source Type: news