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Boston Scientific has announced six-month positive results from its ongoing pivotal MODULAR ATP clinical trial examining the company’s modular cardiac rhythm management (mCRM) technology.
The findings published in the New England Journal of Medicine detail how the system successfully met its primary and secondary endpoints in terms of safety and efficacy, seeing 97.5% of participants experience no complications following the procedure, with an anti-tachycardia pacing (ATP) success rate of 61.3%.
The Boston Scientific device consists of an Emblem subcutaneous implantable defibrillator (S-ICD) system and Empower leadless pacemaker (LP) which coordinate painless intracardiac anti-tachycardia pacing.
Cardiology and Electrophysiology consultant for Boston Scientific, Reinoud Knops said: “We saw excellent overall clinical performance of the mCRM System in this study, including a high rate of communication success from the S-ICD to the leadless pacemaker, and a low rate of major leadless pacemaker complications.
“These findings are noteworthy, as high percentages of communication success and pain-free termination of spontaneous arrhythmia episodes indicate a potential upgrade pathway for patients currently implanted with an S-ICD who develop a need for ATP or pacing.”
Boston Scientfic’s findings were presented before an audience at the Boston-based Heart Rhythm 2024 conference where the company also revealed results from its APPRAISE ATP clinical trial, a prospective, randomised, multicenter study evaluating ATP as a method of treating ventricular tachycardias in primary prevention (PP) patients. That trial has enrolled 2,626 patients indicated to receive an ICD at 134 centres worldwide.
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Research by GlobalData details how the wearable technology market is forecast to grow from $99.5bn in 2022 to $290.6bn in 2030.
Kenneth Stein, chief medical officer for Boston Scientific, said: “Together, data from the MODULAR ATP and APPRAISE ATP trials reinforce the promise of the groundbreaking mCRM System, illustrating a clear path forward for physicians to offer therapies that prevent sudden cardiac death and deliver ATP for the small number of patients who benefit from it.
“Instead of subjecting all patients to the risks of more invasive approaches, such as placing leads in the heart or tunnelling them under the sternum to provide therapies they might not require, these data indicate physicians may have the opportunity to tailor therapy to the patient’s individual needs and health.”
Elsewhere in the field of anti-tachycardia pacing, health tech company Element Science has received an EU CE mark certification and UK Conformity Assessed (UKCA) marketing for its own digital wearable defibrillator. At the same time, the US Food and Drug Administration (FDA) has approved Medtronic’s Aurora EV-ICD MRI SureScan extravascular implantable cardioverter-defibrillator.
This time, the people marched in resistance to the harsh treatment of immigrants by the Trump administration.
“We descend from Immigrants and Revolutionaries,” read a battle cry beamed onto the side of the brick meeting house Tuesday.
“The society that stops seeing the people at the grocery line or the people that ride the bus with us, as human beings with beating hearts, then it’s not far off before our society devolves into no society at all,” Gilberto Calderin, director of advocacy at the Massachusetts Immigrant and Refugee Advocacy Coalition said to the crowd of hundreds.
The protest was organized by activist groups Boston Indivisible and Mass 50501, and began at the Irish Famine Memorial Plaza, just steps from the meeting house.
The lively crowd held up signs, waved American flags, and chanted during the march along Milk Street and Congress Street to the harbor.
Janet England of Brighton held a sign that read, “Democracy Needs Courage.”
The protesters, she said are “true patriots because we want freedom and democracy.”
“Although protest is a long game, we can’t give up. If you think about women’s suffrage, gay rights, the civil rights movement, it took years, but we just can’t give up,” she said.
Gloria Krusemeyer, from Alrington, used a walker to join the march.
“I’m irritated that I haven’t done more, and I’m just lucky that I can walk fast enough to be doing this,” she said.
Rick Mueller, from Cambridge, was dressed as Uncle Sam and held a large sign that read, “Liberty and Justice For All.”
“We’re fighting for America, so I’m gonna be America,” he said of his costume.
He handed small American flags out to protesters who waved them enthusiastically.
Ice dumping duties was limited to volunteers and select people.
Among them was Sarah, a mother who brought her 4-year-old daughter, Fiona.
Sarah declined to share her last name for her daughter’s safety.
After throwing ice into the harbor, Fiona shyly said that she wanted to come to the protest to “help families stay together.”
Through tears, Sarah said her decision to bring along Fiona came from wanting to teach her daughter to care about people from all walks of life.
“Kindness and compassion are things we learn in kindergarten and she will be in kindergarten so it’s really important for her to be kind and compassionate,” Sarah said, kissing her daughter’s check.
Likewise, Sara Sievers, from Cambridge, brought her parents, sister, her nephews and niece to dump ice.
“I think this is one of the most brutal regimes we’ve had in this country, and I want my niece and nephew to remember that it’s important to protest, and that we in Boston are part of a proud tradition of dumping things into the harbor with which we disagree,” Sievers said.
The family wore costumes of historical figures including Abigail Adams, Thomas Jefferson, and King Charles.
As the protest came to a close, Martha Laposata, spokesperson for Boston Indivisible said she wanted protestors to walk away knowing their voices matter.
“We cannot stand down,” Laposata said. “When people rise up against an authoritarian government, if they stay consistent and they keep growing, ultimately an authoritarian government will stand down.”
Camille Bugayong can be reached at camille.bugayong@globe.com.
Crime
An MIT professor was shot and killed in Brookline on Monday night.
Brookline police responded a report of a man shot in his home on Gibbs Street, according to the Norfolk County District Attorney’s Office.
Nuno F.G. Loureiro, 47, was transported to a local hospital and was pronounced dead on Tuesday morning, the DA says.
Loureiro was the director of MIT’s Plasma Science and Fusion Center and a professor of nuclear science and engineering and physics. Originally from Portugal, the Portuguese Minister of Foreign Affairs announced his death in a regulatory hearing before the Committee on Foreign Affairs and Portuguese Communities on Tuesday, according to CNN.
“Sadly, I can confirm that Professor Nuno Loureiro, who died early this morning, was a current MIT faculty member in the departments of Nuclear Science & Engineering and Physics, as well as the Director of MIT’s Plasma Science and Fusion Center. Our deepest sympathies are with his family, students, colleagues, and all those who are grieving,” an MIT spokesperson wrote in a statement.
In January, Loureiro was honored as one of nearly 400 scientists and engineers with the Presidential Early Career Award for Scientists and Engineers from former president Joe Biden.
The investigation into the homicide remains ongoing. No further information was released.
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A man was hospitalized after being shot Monday night in Brookline, Massachusetts.
The shooting happened on Gibbs Street. There was a large police presence at the scene.
The victim was brought to Beth Israel Deaconess Medical Center in Boston. His condition was not known.
Police said the victim was shot three times and grazed by another round.
Authorities did not say if any arrests had been made.
No further information was immediately available.
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