
By Michelle Marchante, Miami Herald (TNS) MIAMI — As her students finished their online exam, Arlet Lara got up to make a cafe con leche . Her 16-year-old son found her on the kitchen floor. First, he called Dad in a panic. Then 911. “I had a stroke and my life made a 180-degree turn,” Lara told the Miami Herald, recalling the medical scare she experienced in May 2020 in the early months of the COVID pandemic. “The stroke affected my left side of the body,” the North Miami woman and former high school math teacher said. Lara, an avid runner and gym goer, couldn’t even walk. “It was hard,” the 50-year-old mom said. After years of rehabilitation therapy and a foot surgery, Lara can walk again. But she still struggles with moving. This summer, she became the first patient in South Florida to get an implant of a new and only FDA-approved nerve stimulation device designed to help ischemic stroke survivors regain movement in their arms and hands. This first procedure was at Jackson Memorial Hospital in Miami. Lara’s rehab was at at the Christine E. Lynn Rehabilitation Center for The Miami Project to Cure Paralysis, part of a partnership between Jackson Health System and UHealth. Every year, thousands in the United States have a stroke , with one occurring every 40 seconds, according to the U.S. Centers for Disease Control and Prevention. The majority of strokes are ischemic, often caused by blood clots that obstruct blood flow to the brain. For survivors, most of whom are left with some level of disability, the Vivistim Paired VNS System, the device implanted in Lara’s chest, could be a game changer in recovery, said Dr. Robert Starke, a UHealth neurosurgeon and interventional neuroradiologist. He also serves as co-director of endovascular neurosurgery at Jackson Memorial Hospital, part of Miami-Dade’s public hospital system. Arlet Lara, the first patient in South Florida to get an FDA-approved nerve stimulation implant, right, runs into her rehabilitation neurology physician Dr. Gemayaret Alvarez, before her physical therapy appointment on Monday, Sept. 9, 2024, at Lynn Rehabilitation Center at Jackson Memorial Hospital. The implant is designed to help stroke survivors regain function in their arms. (Alie Skowronski/Miami Herald/TNS) Arlet Lara, the first patient in South Florida to get an FDA-approved nerve stimulation implant designed to help stroke survivors regain function in their arms, goes through exercises while her therapist activates the device during her physical therapy appointment on Monday, Sept. 9, 2024, at Lynn Rehabilitation Center at Jackson Memorial Hospital. The activation works as positive reinforcement to her muscles when she completes the exercise correctly. (Alie Skowronski/Miami Herald/TNS) Arlet Lara, the first patient in South Florida to get an FDA-approved nerve stimulation implant, does an exercise while Neil Batungbakal, rehabilitation therapist, activates the implant with the black trigger during her physical therapy appointment on Monday, Sept. 9, 2024, at Lynn Rehabilitation Center at Jackson Memorial Hospital. The implant is designed to help stroke survivors regain function in their arms. The activation works as positive reinforcement to her muscles when she completes the exercise correctly. (Alie Skowronski/Miami Herald/TNS) Arlet Lara, the first patient in South Florida to get an FDA- approved nerve stimulation implant, does an exercise while Neil Batungbakal, rehabilitation therapist, activates the implant with the black trigger during her physical therapy appointment on Monday, Sept. 9, 2024, at Lynn Rehabilitation Center at Jackson Memorial Hospital. Arlet Lara, the first patient in South Florida to get an FDA-approved nerve stimulation implant, right, runs into her rehabilitation neurology physician Dr. Gemayaret Alvarez, before her physical therapy appointment on Monday, Sept. 9, 2024, at Lynn Rehabilitation Center at Jackson Memorial Hospital. The implant is designed to help stroke survivors regain function in their arms. (Alie Skowronski/Miami Herald/TNS) The Vivistim Paired VNS System is a small pacemaker-like device implanted in the upper chest and neck area. Patients can go home the same day. The U.S. Food and Drug Administration approved the stroke rehabilitation system in 2021 to be used alongside post-ischemic stroke rehabilitation therapy to treat moderate to severe mobility issues in hands and arms. Lara’s occupational therapist can activate the device during rehabilitation sessions to electrically stimulate the vagus nerve, which runs from the brain down to the abdomen and regulates various parts of the body’s nervous system. The electrical stimulation rewires the brain to improve a stroke survivor’s ability to move their arms and hands. Lara also has a magnet she can use to activate the device when she wants to practice at home. Her therapy consists of repetitive tasks, including coloring, pinching cubes and grabbing and releasing cylindrical shapes. After several weeks of rehabilitation therapy with the device, Lara has seen improvement. “Little by little, I’m noticing that my hand is getting stronger. I am already able to brush my teeth with the left hand,” she told the Miami Herald in September. Since then, Lara has finished the initial six-week Vivitism therapy program, and is continuing to use the device in her rehabilitation therapy. She continues to improve and can now eat better with her left hand and can brush her hair with less difficulty, according to her occupational therapist, Neil Batungbakal. Lara learned about the device through an online group for stroke survivors and contacted the company to inquire. She then connected them with her Jackson medical team. Now a year later, the device is available to Jackson patients. So far, four patients have received the implant at Jackson. Related Articles Health | Washington power has shifted. Here’s how the ACA may shift, too Health | CDC chief urges focus on health threats as agency confronts political changes Health | New rule allows HIV-positive organ transplants Health | Biden proposes Medicare and Medicaid cover costly weight-loss drugs for millions of obese Americans Health | Do not wash your turkey and other Thanksgiving tips to keep your food safe Starke sees the device as an opportunity to help bring survivors one step closer to regaining full mobility. Strokes are a leading cause of disability worldwide. While most stroke survivors can usually recover some function through treatment and rehabilitation, they tend to hit a “major plateau” after the first six months of recovery, he said. Vivistim, when paired with rehabilitation therapy, could change that. Jackson Health said results of a clinical trial published in the peer-reviewed medical journal The Lancet in 2021 showed that the device, “when paired with high-repetition, task-specific occupational or physical therapy, helps generate two to three times more hand and arm function for stroke survivors than rehabilitation therapy alone.” The device has even shown to benefit patients 20 years from their original stroke, according to Starke. “So now a lot of these patients that had strokes 10-15 years ago that thought that they would never be able to use their arm in any sort of real functional way are now able to have a real meaningful function, which is pretty tremendous,” Starke said. Vivistim’s vagus-nerve stimulation technology was developed by researchers at the University of Texas at Dallas’ Texas Biomedical Device Center and is being sold commercially by Austin-based MicroTransponder, a company started by university graduates. Similar devices are used to treat epilepsy and depression . For Lara, the device is a new tool to help her recovery journey. “Everything becomes a challenge so we are working with small things every day because I want to get back as many functions as possible,” Lara said. Patients interested in Vivistim should speak with their doctor to check their eligibility. The FDA said patients should make sure to discuss any prior medical history, including concurrent forms of brain stimulation, current diathermy treatment, previous brain surgery, depression, respiratory diseases and disorders such as asthma, and cardiac abnormalities. “Adverse events included but were not limited to dysphonia (difficulty speaking), bruising, falling, general hoarseness, general pain, hoarseness after surgery, low mood, muscle pain, fracture, headache, rash, dizziness, throat irritation, urinary tract infection and fatigue,” the FDA said. MicroTransponder says the device is “covered by Medicare, Medicaid, and private insurance with prior authorization on a case-by-case basis.” To learn more about the device, visit vivistim.com. ©2024 Miami Herald. Visit at miamiherald.com. Distributed by Tribune Content Agency, LLC. 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A stroke changed a teacher’s life. How a new electrical device is helping her moveiPhone fans predict release date of upcoming iOS 18 update in leaks from cellular provider READ MORE: iOS 18 update causes banking issues for iPhone users By NIKKI MAIN SCIENCE REPORTER FOR DAILYMAIL.COM Published: 21:35, 5 December 2024 | Updated: 21:48, 5 December 2024 e-mail 1 View comments Apple fans are predicting the release date for the new iOS 18.2 update after spotting a clue shared by a cellphone provider. The British mobile network, EE, recently announced that customers wouldn't be able to use their shared number service on MacBooks and iPads starting December 9. The majority of carrier updates are released alongside Apple software updates, meaning that the phone company may have indirectly revealed when iOS 18.2 will be released to all users. The information has set social media a blaze with iPhone users rejoicing about the upcoming iOS date. 'Apple is expected to release iOS 18.2 in December, possibly on Dec. 9,' a user shared on X. 'The update could feature expanded Apple Intelligence capabilities, which is what a lot of us Apple users are eagerly awaiting,' they added. The third iOS 18.2 beta test was released on November 20, which introduced Wi-Fi calling for other devices and new Apple Intelligence features. However, the company hasn't confirmed when all of it's 1.46 billion global customers would receive the update. Apple fans have guessed that the company will publicly release its iOS 18.2 software update on December 9. This is based on a phone carrier's message to its customers saying it would remove its Smart number service Last month, some Apple users had speculated that the iOS 18.2 update would be issued on December 2, but EE's message appeared to indicate a later release. 'Recently received a message from about their Smart Number service ending on 9 December,' one person wrote on X. 'Now, MacRumors suggests this could hint at the iOS 18.2 release date. Any other users seeing this as a sign? Up until now, my money was on 2nd December.' EE told its customers: 'We wanted to let you know that, from 09 December, you'll no longer be able to use your EE shared number service on MacBooks and iPads. 'Watch functionality, along with the Apple-provided iCloud number-sharing function, won’t be affected. 'We’re sorry for any inconvenience caused by this update.' Some iPhone users reported that a December 9 release date would make sense because Apple typically issues its updates on a Monday and doesn't make any new changes to its software during the holiday season. The iOS 18.2 update will include the Image Playground feature (pictured) that lets users create a cartoon-like image from pictures in their photo library or other prompts The update will also include a Genmoji feature which uses text prompts for users to create their own custom emojis The update will introduce new Apple Intelligence features for iPhone 15 Pro and iPhone 16 models including Genmoji, Image Playground and ChatGPT integration for Siri. Read More EXCLUSIVE iPhone expert tests Apple Intelligence features on iOS Genmoji will allow customers to use text prompts create their own custom emoji image which will be accessible through the Messages and Notes apps . Likewise, Image Playground utilizes text descriptions, concepts and pictures from the photo library to create a cartoon illustration on their iPhone. It will also include Visual Intelligence which lets users identify what's around them by using the Camera app which will provide information about nearby stores and restaurants. The update will come with a new writing tool that offers more customization for text message and emails that will automatically generate the tone and format based on the user's prompts. Users expressed their excitement about the new features, with one person touting on X: 'Apple launch iOS 18.2. this is the huge update in iOS history!' iPhone Share or comment on this article: iPhone fans predict release date of upcoming iOS 18 update in leaks from cellular provider e-mail Add comment
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