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'Democracy and freedom': Jimmy Carter's human rights efforts in Latin America
Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $50,000 In PACS Group To Contact Him Directly To Discuss Their Options If you suffered losses exceeding $50,000 in PACS Group between (a) common stock pursuant and/or traceable to the registration statement and prospectus (collectively, the “Registration Statement”) issued in connection with the Company’s April 11, 2024 initial public offering (“IPO” or the “Offering”); and/or (b) all persons and entities that purchased or otherwise acquired PACS common stock pursuant, or traceable, or both, to the SPO Materials (as defined herein) issued in connection with PACS’ September 2024 secondary public offering (the “SPO”); and/or (c) securities between April 11, 2024 and November 5, 2024 inclusive (the “Class Period”) and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310) . [You may also click here for additional information] NEW YORK, Dec. 26, 2024 (GLOBE NEWSWIRE) -- Faruqi & Faruqi, LLP , a leading national securities law firm, is investigating potential claims against PACS Group, Inc. (“PACS Group” or the “Company”) (NYSE: PACS) and reminds investors of the January 13, 2025 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company. Faruqi & Faruqi is a leading national securities law firm with offices in New York, Pennsylvania, California and Georgia. The firm has recovered hundreds of millions of dollars for investors since its founding in 1995. See www.faruqilaw.com . As detailed below, the complaint alleges that the Company and its executives violated federal securities laws by making false and/or misleading statements and/or failing to disclose that: (1) that the Company engaged in a “scheme” to submit false Medicare claims which “drove more than 100% of PACS’ operating and net income from 2020 – 2023”; (2) that the Company engaged in a “scheme” to “bill thousands of unnecessary respiratory and sensory integration therapies to Medicare”; (3) that the Company engaged in a scheme to falsify documentation related to licensure and staffing; and (4) that, as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis. On April 11, 2024, PACS Group conducted its IPO, selling 21,428,572 shares of common stock at a price of $21.00 per share, received net proceeds of approximately $450 million. On September 3, 2024, PACS filed with the SEC a registration statement for a secondary offering on Form S-1 (the “SPO Registration Statement”). On September 6, 2024, PACS filed with the SEC a prospectus for the SPO on Form 424B4, which formed part of the SPO Registration Statement (the “SPO Prospectus” and together with the SPO Registration Statement and attendant materials filed or published with these forms, the “SPO Materials.” PACS issued 2,777,778 shares of common stock at $36.25 per share for proceeds of $100.7 million to the Company. Through the SPO, PACS insiders also sold 16,256,704 shares of common stock at $36.25 per share for proceeds of $589.3 million. On November 4, 2024, Hindenburg Research published a report based on a 5-month investigation that included interviews with 18 former PACS Group employees, competitors, and an analysis of more than 900 PACS facility cost reports. The report alleged the Company had “abused a COVID-era waiver” in a “scheme” that involved falsely submitting false Medicare claims which “drove more than 100% of PACS’ operating and net income from 2020 – 2023, enabling PACS to IPO in early 2024 with the illusion of legitimate growth and profitability.” The report further alleged the Company engaged in a scheme to maintain revenue by “bill[ing] thousands of unnecessary respiratory and sensory integration therapies to Medicare Part B regardless of clinical need or outcomes.” The report also alleged a widespread practice of falsifying documentation, including by engaging in a “scheme whereby PACS attempts to fool regulators by ‘renting’ licenses from third parties to ‘hang’ on buildings” and then “either employs unlicensed administrators or has administrators manage multiple buildings in excess of state mandated limits.” Similarly, the report alleges the Company engaged in a scheme related to licensure and staffing of nurses, whereby “PACS secretly lists uncertified nurse aides (NAs) as certified in the system, in an apparent scheme to cheat staffing ratios” and “retroactively add fake RN hours” in order “to meet minimum staffing requirements, boost star ratings, and avoid costly penalties.” On this news, the Company’s share price fell $11.93 or 27.78%, to close at $31.01 per share on November 4, 2024, on unusually heavy trading volume. Then, on November 6, 2024, before the market opened, the Company announced that it would postpone its fiscal third quarter 2024 earnings release. The Company further disclosed it had “received civil investigative demands from the federal government regarding the Company’s reimbursement and referral practices that may or may not be related to this week’s third-party report.” On this news, the Company’s share price fell $11.45 or 38.76%, to close at $18.09 per share on November 6, 2024, on unusually heavy trading volume. By the commencement of this action, PACS Group stock has traded as low as $18.09 per share, a more than 13.9% decline from the $21 per share IPO price. The court-appointed lead plaintiff is the investor with the largest financial interest in the relief sought by the class who is adequate and typical of class members who directs and oversees the litigation on behalf of the putative class. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member. Your ability to share in any recovery is not affected by the decision to serve as a lead plaintiff or not. Faruqi & Faruqi, LLP also encourages anyone with information regarding PACS Group’s conduct to contact the firm, including whistleblowers, former employees, shareholders and others. To learn more about the PACS Group class action, go to www.faruqilaw.com/PACS or call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310) . Follow us for updates on LinkedIn , on X , or on Facebook . Attorney Advertising. The law firm responsible for this advertisement is Faruqi & Faruqi, LLP ( www.faruqilaw.com ). Prior results do not guarantee or predict a similar outcome with respect to any future matter. We welcome the opportunity to discuss your particular case. All communications will be treated in a confidential manner. A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5e848124-9c14-4bab-ba13-256ecec0c433
On Jan. 20, 1981, after suffering a landslide defeat, former President Jimmy Carter returned home to rural Plains to what he called “an altogether new, unwanted, and potentially empty life.” By 1982, he had such a low profile that Time magazine called him “virtually a non-person, a president who never was.” But Carter would rewrite his legacy by turning to his implacable faith. It was, to him, an enduring source of comfort and inspiration, continuously helping guide him even through the most stunning setbacks — from losing elections to marital woes, an interminable hostage crisis in Iran and health crises in later life. His hometown of Plains wasn’t just Carter’s childhood home — it was his spiritual center. Upon his return after his presidential defeat, Carter, a third-generation Baptist, maintained his lifetime habit — teaching Sunday school at Maranatha Baptist Church. He made a cross that stood for years above the altar in his wood shop. As an active member, he took his turn cutting the church’s grass. And he applied his love-your-neighbor ethic to his work at the Carter Center. “He is not some pie-in-the-sky Christian. He is a down-to-earth Christian who sees the everyday challenges and applies his faith to practical problems,” said civil rights hero the Rev. Joseph Lowery in an October 2010 interview. “There is no question his commitment to peace is based on faith. His commitment to help the poor, his commitment to housing, you can attribute that to his faith. It was Christ’s challenge to serve the poor and he’s done that. I admire him for that.” In his 1996 book “Living Faith,” Carter wrote openly about problems in his marriage. Getting involved in the church in Plains helped him and his wife work though communication woes. “We found we could communicate through discussions of our religious faith better than we could without it,” he said. When they had problems in their marriage, they would kneel together, pray to God and both would tell their sides of the story. It was as if they used God as the ultimate marriage counselor, according to E. Stanly Godbold, a Carter historian and author of the book, “Jimmy and Rosalynn Carter: The Georgia Years, 1924 to 1974.” Faith played a role in 1978 when Carter held peace meetings between Egyptian President Anwar Sadat and Israeli Prime Minister Menachem Begin. Carter believed the common thread of religion helped bring the two sides together. “At Camp David, for instance, this is one of the main themes of Anwar Sadat, we had so much in common worshipping the same God that we could form a common foundation for peace,” Carter told the AJC in a 1996 interview. READ AN EXCERPT OF PRESIDENT JIMMY CARTER’S BOOK, “ FAITH: A JOURNEY FOR ALL,” WHICH WAS PRINTED IN THE AJC IN 2018. Break with Southern Baptists When Carter was running for president, he was an appealing candidate to Southern Baptists and other evangelicals — a small town guy in the Bible belt, still married to the same woman and the first U.S. presidential candidate who self-identified as a born-again Christian. That terminology was new for swaths of America and resulted in news articles across the nation examining and explaining, often poorly, conservative Christian beliefs. It was also an early sign of the development of the political-religious organizations such as the Rev. Jerry Falwell’s Moral Majority that followed. The evangelical Christian vote helped elect Carter. But in just four years, the most famous face of the Baptist religion was at odds with the increasingly conservative-leaning Southern Baptist Convention. The nation’s largest Protestant denomination also was undergoing its own cultural changes. Through the 1980s, theologically and politically conservative leaders rallied voting members of the convention to sweep out moderates from leadership roles in churches, seminaries and colleges over their theological “liberalism.” Carter’s views on hot-button issues such as supporting women as leaders in the church made him increasingly unpopular among many Southern Baptists and other evangelicals. He later showed support for civil unions, and by 2018 for marriage of same sex couples. But in 1979, many of the conservatives who voted for him the first time deserted him for Ronald Reagan. In 2000, Carter severed ties to the Southern Baptist Convention, saying parts of its “increasingly rigid” doctrines violated the “basic premises of my Christian faith.” Carter went on to play a role in helping start an alternate association for progressive evangelical Black and white churches whose memberships and leaders were more moderate in their thinking and actions, such as installing women into pulpits and key church roles, and focusing on goals such as fighting poverty, and advocating for the environment and social causes. Carter used his weight to get the New Baptist Covenant and Cooperative Baptist Fellowship off the ground. In 2008, he helped bring together 20,000 Baptists representing more than 20 million church members for an Atlanta event designed to bury differences and work together. The tension was deep. The Southern Baptist Convention’s news service, Baptist Press, did not carry a news article about Carter winning the Nobel Peace Prize. “Carter didn’t change,” said Nancy T. Ammerman, a sociologist of religion at Boston University and author of “Baptist Battles.” “The definition of what it meant to be Southern and Baptist changed.” “One of the characteristics of being Baptist is this that you have to make decisions about how your life is going to go,” said Ammerman. “No priest can do it for you. There’s this deep-seated notion of individual freedom and individual accountability, and [that] gave him this fierce ability to be independent that has shaped his personality and career and has given him a strong commitment to democracy, various human rights issues and religious liberty.” An abiding faith Carter’s faith can be traced back to his childhood, a time when Sunday was devoted to church and biblical teachings. In his hometown of Plains, no stores were open on Sunday. Going to a movie theater or even playing cards on Sunday was out of the question. That devotion never faded. Well into his 90s, he was behind the pulpit teaching multiple Sundays every year to classes filled with people from around the nation and world who would drop in to hear the former president. One Sunday, Carter counted 28 nations represented in the pews. He would talk about God and loving your enemies, and then sprinkle stories of traveling around the globe, building houses and eradicating disease. He and Rosalynn would pose for pictures with visitors at the little church, a quintessential Jimmy Carter experience. Even as he contemplated his demise, he looked to his faith for guidance. In “Living Faith,” he wrote: “We can face death with fear, anguish, self-torment and unnecessary distress among those around us. Or, through faith and the promises of God, we can confront the inevitable with courage, equanimity, good humor and peace. Our last few days or months can be spent in a challenging and exhilarating way, seeking to repair relationships and to leave a good or even noble legacy, in an atmosphere of harmony and love.”
ORONO, Maine (AP) — Michael McNair scored 16 points to lead Boston University and Malcolm Chimezie sealed the victory with a layup with 20 seconds left as the Terriers took down Maine 59-56 on Sunday. McNair also had six rebounds for the Terriers (6-7). Kyrone Alexander scored 13 points and added five rebounds. Chimezie shot 4 of 7 from the field and 0 for 3 from the line to finish with eight points. Kellen Tynes led the way for the Black Bears (8-7) with 17 points, four assists and three steals. Maine also got 12 points from Christopher Mantis. Quion Burns had eight points. McNair scored seven points in the first half and Boston University went into halftime trailing 27-19. Alexander scored a team-high 10 points for Boston University in the second half. Boston University outscored Maine by 11 points over the final half. Boston University's next game is Thursday against Lafayette on the road, and Maine visits Bryant on Saturday. The Associated Press created this story using technology provided by Data Skrive and data from Sportradar .
After Trump's win, Black women are rethinking their role as America's reliable political organizers
External Affairs Minister S. Jaishankar met with the United States National Security Advisor, Jake Sullivan, in Washington, DC, on Thursday. In a post on X, Mr Jaishankar said that the two leaders held wide-ranging discussions on the progress of the India-US strategic partnership and exchanged views on current regional and global developments. "Good to meet US NSA @JakeSullivan46 in Washington D.C. this morning. A wide ranging discussion on the progress of India-US strategic partnership. Also exchanged views on current regional and global developments", Mr Jaishankar wrote on X. Good to meet US NSA @JakeSullivan46 in Washington D.C. this morning. A wide ranging discussion on the progress of 🇮🇳 🇺🇸 strategic partnership. Also exchanged views on current regional and global developments. pic.twitter.com/RtvTNAlHq7 — Dr. S. Jaishankar (@DrSJaishankar) December 26, 2024 As per a press release by the Ministry of External Affairs, S Jaishankar is visiting the United States of America from December 24 to December 29. The External Affairs Minister will meet counterparts to discuss key bilateral, regional and global issues. During the visit, Jaishankar will also chair a conference of the Consul Generals of India in the USA, the MEA noted in its press release. The visit by the External Affairs Minister comes after Prime Minister Narendra Modi visited the US earlier in September and participated in the fourth Quad Leaders' Summit in Wilmington, Delaware. The US and India have seen frequent high-level interactions. Earlier on Tuesday, senior diplomats from India and the United States, including Deputy Secretary of State Richard Verma, highlighted the strengthening of bilateral ties between the two countries. India-US bilateral relations have developed into a "global strategic partnership," based on shared democratic values and increasing convergence of interests on bilateral, regional and global issues. Regular exchange of high-level political visits has provided sustained momentum to bilateral cooperation, while the wide-ranging and ever-expanding dialogue architecture has established a long-term framework for India-US engagement. (Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)
The Berlin government has sliced the city’s arts and culture budget by €130 million (about $135 million), sparking concerns that institutions may be forced to close and imperiling the German capital’s status as an arts hub. The cuts, which represent 12 percent of the sector’s budget, are part of the city’s 2025 spending plan and have been robustly defended by Berlin’s mayor, Kai Wegner, a member of the right-wing Christian Democratic Union. According to the Art Newspaper (TAN), Wegner blamed the cuts on the “green dreams” of the prior, left-wing administration, citing a need for a “change of mentality” and pointing to the city’s “record” €40 billion budget. Bandied about for weeks, the cuts almost certainly place jobs and programs in jeopardy, and the arts community has been vocal about these and other possible negative outcomes, including a tamping-down of experimental or less commercial programming. Emma Enderby, director of the nonprofit KW Institute for Contemporary Art, told TAN that “culture and clubs bring people to Berlin. They don’t come here for the food, they come here for the history and the culture.” Enderby noted that organizations have still not received information regarding the full budget and that it may not be communicated until mid-January. Nevertheless, with such notice, institutions are already making difficult choices. “We are letting certain positions go and closing certain programmatic initiatives, such as one of our mediation programs,” Enderby told TAN. Calling the cuts “short-sighted,” she explained that “in Berlin, culture costs around 2 percent of the overall economy, yet they’re cutting us between around 10 percent and in some cases 50 percent.” “It’s a very bad decision—pennywise and pound foolish in every sense,” Paul Spies, a co-president of the Berlin Museums Association and former director of the Stiftung Stadtmuseum Berlin, told the publication. “And it’s been done so bluntly and without input from the cultural department. It doesn’t seem that the Senate has listened to the specialists about what is possible and what is not possible.” Along with musuems, artists are expected to be affected by the cuts. “Many initiatives like studio spaces and residences that support them are also being removed or cut,” said Enderby, “which will completely change the attractiveness of coming to Berlin, an increasingly expensive city to live in.”'Democracy and freedom': Jimmy Carter's human rights efforts in Latin America
Shoplifting ring stole $2M in cosmetics and clothes then resold them abroad, prosecutors say
EAST RUTHERFORD, N.J. (AP) — New York Giants quarterback Tommy DeVito came out of his first start of the season with a sore throwing arm and his status for Thursday's game against the Cowboys in Dallas is uncertain. DeVito was not listed on Monday's injury report and coach Brian Daboll said he did not know about the injury to the quarterback's right arm until just before the team had a walkthrough practice on Tuesday. Daboll said he was hopeful DeVito would play, but he added that backup Drew Lock will get a couple of extra snaps in the short workout. “If Tommy is good, then Tommy will be the guy,” Daboll said. Having played on Sunday, the Giants (2-9) are prepping for the Cowboys (4-7) with walkthroughs. After the workout on Tuesday, DeVito said his whole body was still sore, even his neck. He planned to test his arm on Wednesday before the team headed to Dallas. “The plan is to play," DeVito said. “We’ll see how I feel tomorrow. Hopefully wake up feeling a little bit better after I get some more treatment today. Looking forward to tomorrow.” DeVito was given the starting job last week when Daboll benched Daniel Jones after five straight losses. Jones asked co-owner John Mara to cut him on Friday and the team released him so he could pursue other opportunities after he cleared waivers on Monday, which he did. DeVito was 21 of 31 for 189 yards in a 30-7 loss to the Tampa Bay Buccaneers. He was sacked four times and missed one play in the fourth quarter after being hit hard after making a throw. Lock said the uncertainty about playing is the life of a backup. He noted playing one play after DeVito was hurt in the fourth quarter was a first for him. “Always got to be ready,” he said. “No matter what the week, no matter what the situation is, just playing like you’re going to go in there and play. My mindset didn’t change this week, and we’ll see how the rest of the week shakes out.” AP NFL: https://apnews.com/hub/nflHow To Watch IND vs AUS 4th Test 2024 Day 2 Free Live Streaming Online? Get Free Telecast Details of India vs Australia Border-Gavaskar Trophy Cricket Match on TV
Prep football | Ferndale advances to NCS championship with 43-7 drenching of PiedmontRyan Outerbridge is set to compete in the NCAA Division II Cross Country Championships in Sacramento, California, tomorrow [November 23]. For the 21-year-old, it marks a remarkable journey of resilience and recovery. In 2021, Outerbridge suffered a heart attack while competing for Franklin Pierce University at the Lewis Crossover meet in Chicago. “When it first happened, I didn’t even know what had happened,” Outerbridge recalled in an . “I remember waking up on the ground, not much else. The whole ride to the hospital was blurry, in and out of consciousness. “It’s a pretty traumatising period of my life. I make jokes about it now and then, but it’s a cover-up of how big of a deal it really was.” Outerbridge spent two weeks wearing a heart monitor, his season abruptly cut short. Uncertainty loomed over his future in athletics, and the question of whether he would ever compete again weighed heavily on him. However, by January 2022, Outerbridge made a comeback, reclaiming his form and confidence, earning medals in relays at the NE10 Conference Indoor Championships later that same season. His went on to set personal records in the 5K and 8K races. Outerbridge also earned All-Conference First Team honours and achieved a top-ten finish at regionals, playing a crucial role in helping his team qualify for nationals—a feat accomplished only twice in Franklin Pierce University’s history. “It was like night and day, what can change in a year,” he said, reflecting on his recovery and resurgence in competitive running. Since his comeback, he has amassed an impressive collection of accolades, including three conference gold medals in the 1,500 metres, 4×800 relay, and steeplechase. This year, he also finished second behind Lamont Marshall in the Bermuda Half-Marathon Derby. “Running has been my passion since I was seven or eight years old,” he said. “It’s hard to speak up about what happened, but running on this stage—it’s what I always wanted.” “Looking back, words can’t even explain how I feel. To see where I’ve come in my collegiate career—it’s something I carry with me every time I step on the course.” : ,
( MENAFN - Investor Brand Network) Central banks around the world have been ramping up their accumulation of gold, creating one of the most significant market shifts in years. Over the last two years, governments added over 2,000 tonnes of Gold to their reserves ( )-a pace not seen in the last 20 years. While economic headlines often focus on inflation or interest rate cycles, this relentless accumulation of gold reveals something deeper: a global move to hedge against uncertainty and challenge the dominance of traditional reserve currencies like the U.S. dollar. For investors, it raises an obvious question-if the... Read More>> NOTE TO INVESTORS: The latest news and updates relating to MUX are available in the company's newsroom at About AINewsWire AINewsWire (“AINW”) is a specialized communications platform with a focus on the latest advancements in artificial intelligence (“AI”), including the technologies, trends and trailblazers driving innovation forward. It is one of 70+ brands within the Dynamic Brand Portfolio @ IBN that delivers : (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries ; (2) article and editorial syndication to 5,000+ outlets ; (3) enhanced press release enhancement to ensure maximum impact ; (4) social media distribution via IBN to millions of social media followers ; and (5) a full array of tailored corporate communications solutions . With broad reach and a seasoned team of contributing journalists and writers, AINW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists, and the general public. By cutting through the overload of information in today's market, AINW brings its clients unparalleled recognition and brand awareness. AINW is where breaking news, insightful content and actionable information converge. To receive SMS alerts from AINewsWire, text“AI” to 888-902-4192 (U.S. Mobile Phones Only) For more information, please visit AINewsWire is powered by IBN MENAFN26122024000224011066ID1109033813 Legal Disclaimer: MENAFN provides the information “as is” without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the provider above.
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) What to know about the stroke device 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. How it worked on the first Jackson patient 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. 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. More about the device 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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