Connect with us
  • tg

Stock Markets

MODULAR ATP Study of the mCRM™ System Meets Primary Safety and Efficacy Endpoints

letizo News

Published

on

Additional data from APPRAISE ATP trial reinforce modular therapy approach with EMBLEM™ Subcutaneous Implantable Defibrillator and EMPOWER™ Leadless Pacemaker

MARLBOROUGH, Mass., May 18, 2024 /PRNewswire/ — Boston Scientific Corporation (NYSE: NYSE:) today announced positive six-month results from the ongoing pivotal MODULAR ATP clinical trial of the mCRM™ System, the first modular cardiac rhythm management (CRM) system that consists of the EMBLEM™ Subcutaneous Implantable Defibrillator (S-ICD) System and the EMPOWER™ Leadless Pacemaker (LP). As components of the mCRM System, the devices are designed to work together wirelessly to coordinate painless intracardiac anti-tachycardia pacing (ATP) therapy, provide rate-responsive bradycardia pacing support and to prevent sudden cardiac death without the risk of leads in the heart or under the sternum. Findings were presented at Heart Rhythm 2024, the annual meeting of the Heart Rhythm Society, and simultaneously published in The New England Journal of Medicine.

In addition to evaluating the safety and performance of the EMPOWER LP as a standalone pacemaker, the trial evaluated the ability of the EMBLEM S-ICD System to successfully communicate a wireless request to the LP to deliver ATP therapy. Findings from the trial met all pre-specified six-month safety and effectiveness endpoints, and demonstrated:

  • A major complication-free rate of 97.5% after implantation of the EMPOWER LP.1
  • A communication success rate of 98.8% from the EMBLEM S-ICD System to the EMPOWER LP.2
  • An ATP success rate of 61.3%,3 and no patient requests for deactivation of ATP or bradycardia pacing due to pain or discomfort.
  • Pacing capture thresholds, which indicate stable device fixation within the heart, of ‰¤ 2.0 V at 0.4 ms in 97.4% of patients.

“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,” said Prof. Reinoud Knops, M.D., Ph.D., Department of Cardiology and Electrophysiology, Amsterdam UMC, Amsterdam, Netherlands. “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.”

Also presented at Heart Rhythm 2024 were results from the APPRAISE ATP clinical trial “ a prospective, randomized, multicenter study evaluating ATP as a primary strategy for terminating ventricular tachycardias in primary prevention (PP) patients (i.e., those without a history of spontaneous sustained ventricular arrhythmias). The trial enrolled 2,626 PP patients indicated to receive an ICD at 134 centers globally and is the largest head-to-head trial of ATP in this patient group. In the study, patients were randomized 1:1 to standard transvenous-ICD therapy “ ATP plus an ICD-delivered shock to terminate a ventricular tachycardia “ versus shock only. Across five years of follow up, data demonstrated a statistically significant, but small absolute first all-cause shock reduction in only 1% of patients per year. Shock burden, or the number of shocks experienced by a patient, was not significantly different between the two arms, and the vast majority of patients in the ATP-plus-shock arm did not require ATP therapy.

“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,” said Kenneth Stein, M.D., senior vice president and global chief medical officer, Boston Scientific. “Instead of subjecting all patients to the risks of more invasive approaches, such as placing leads in the heart or tunneling 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.”

The company anticipates U.S. Food and Drug Administration approval of the mCRM System in 2025. For more information on the mCRM System and MODULAR ATP trial, visit www.bostonscientific.com/mcrm. To learn more about the EMBLEM MRI S-ICD System, visit www.sicdsystem.com.

The EMPOWER LP is an investigational device and limited by U.S. law to investigational use only. It is not available for sale. Some device references are for informational purposes only and are pending CE Mark. Not available in the European Economic Area.

Dr. Reinoud Knops is a paid consultant of Boston Scientific Corporation. He has not been compensated in connection with this press release.

About Boston Scientific
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and connect on LinkedIn and X, formerly Twitter.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like “anticipate,” “expect,” “project,” “believe,” “plan,” “estimate,” “intend” and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding our business plans and product performance and impact, and new and anticipated product approvals and launches. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.

Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; manufacturing, distribution and supply chain disruptions and cost increases; variations in outcomes of ongoing and future clinical trials and market studies; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A “ Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A “ Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements, except as required by law. This cautionary statement is applicable to all forward-looking statements contained in this document.

CONTACTS:Steve Bailey
Media Relations
(651) 582-4343 (office)
Steve.Bailey@bsci.com

Jon Monson
Investor Relations
(508) 683-5450
BSXInvestorRelations@bsci.com

1 Major complications defined as any complication related to the EMPOWER LP or its implantation procedure that results in system revision, permanent loss of LP function, hospitalization, or death.
2 During communication tests, the S-ICD attempted to command the LP to deliver pacing at a rate approximately 10 beats per minute faster than the patient’s intrinsic rhythm.
3 ATP success rate defined as terminating ventricular arrhythmia.

Stock Markets

Sean ‘Diddy’ Combs charged with sex trafficking, racketeering

letizo News

Published

on

By Luc Cohen and Jonathan Stempel

NEW YORK (Reuters) -Sean “Diddy” Combs used his fame as one of the biggest names in hip-hop to coerce women into engaging in demeaning sex acts as part of a long-running scheme of sex trafficking and racketeering, according to a three-count federal indictment unsealed on Tuesday.

Combs, 54, used the business empire he controlled, including his record label Bad Boy Entertainment, to transport women, as well as male sex workers, across state lines to take part in recorded sexual performances called “Freak Offs” in which the music mogul would watch and masturbate, prosecutors said.

The rapper and producer, arrested in Manhattan on Monday night, is expected to appear in court before U.S. Magistrate Judge Robyn Tarnofsky at 2:30 p.m. EDT (1830 GMT) on Tuesday.

Combs faces a mandatory minimum 15-year prison sentence and up to life behind bars if convicted of the three felony counts: racketeering conspiracy, sex trafficking and transportation to engage in prostitution.

The office of Manhattan U.S. Attorney Damian Williams, which brought the charges, said in a court filing that the stiff potential sentence could give Combs incentive to flee.

Prosecutors have asked Tarnofsky to order Combs to remain detained pending trial. Defense lawyers are asking to have him released on $50 million bond secured by his Miami home.

Prosecutors accused Combs of running a criminal enterprise to facilitate his exploitation of women, dating back at least 16 years.

According to the indictment, Combs enticed women by giving them drugs such as ketamine and ecstasy, financial support, or promises of career support or a romantic relationship. Combs then used surreptitious recordings of the sex acts as “collateral” to ensure that the women would remain silent, and sometimes displayed weapons to intimidate abuse victims and witnesses, prosecutors said.

“The victims did not believe they could refuse Combs without risking their security or facing more abuse,” Williams told a press conference. “This office is determined to investigate and prosecute anyone who engages in sex trafficking, no matter how powerful or wealthy or famous you may be.”

The indictment did not specify how many women were alleged victims. It contained no allegation that Combs himself directly engaged in unwanted sexual contact with women, though he was accused of assaulting them by punching, kicking, dragging and throwing objects.

Also known during his career as P. Diddy and Puff Daddy, Combs founded Bad Boy records and is credited with helping turn rappers and R&B singers such as Mary J. Blige, Faith Evans, Notorious B.I.G. and Usher into stars in the 1990s and 2000s.

‘NOT A CRIMINAL’

Marc Agnifilo, a lawyer for Combs, did not immediately respond to a request for comment on Tuesday. Agnifilo on Monday expressed disappointment with the “unjust” prosecution of his client, calling Combs “an imperfect person” but “not a criminal.”

Combs is the highest-profile music industry figure charged with sexual misconduct since R&B singer R. Kelly was sentenced to a combined 31 years in prison after being convicted in New York in 2021 and Chicago in 2022 sex trafficking, racketeering, child sex crimes and other counts.

His career and reputation have been marred over the past year. Last November, his former girlfriend Casandra Ventura, an R&B singer known as Cassie, accused him in a lawsuit of serial physical abuse, sexual slavery and rape. She agreed to an undisclosed settlement one day after suing. Combs denied her allegations.

New York Mayor Eric Adams asked Combs to return a commemorative “key to the city” after a video showing him attacking Cassie surfaced in May.

BABY OIL, AR-15 RIFLES

Prosecutors said Combs and his associates used bribery and violence such as arson and kidnapping to try to keep his conduct secret.

In a March 2016 incident that resembles Cassie’s description of his alleged attack, prosecutors said Combs was captured on a hotel security video striking and dragging a woman trying to leave a “Freak Off.” Combs then offered a stack of cash to a hotel security officer who intervened, prosecutors said.

In 2011, Combs and a co-conspirator kidnapped a person at gun point to facilitate a break in, prosecutors said. Two weeks later, Combs’ co-conspirators set a car on fire, and he later bragged about his role in the arson, prosecutors said.

© Reuters. FILE PHOTO: Rapper Sean Diddy Combs arrives at the 2016 MTV Video Music Awards in New York, U.S., August 28, 2016.  REUTERS/Eduardo Munoz/File Photo

Prosecutors said Combs’ employees helped arrange the “Freak Offs” by booking hotel rooms and buying controlled substances and other items used during sex, according to the indictment.

During raids of his homes in Los Angeles and Miami Beach, Florida six months ago, authorities found drugs and 1,000 bottles of baby oil and lubricant, along with AR-15 rifles with defaced serial numbers, the indictment said.

Continue Reading

Stock Markets

Wysh Collaborates with Jack Henry to Enhance Financial Protection for Credit Union Members

letizo News

Published

on

Community and regional financial institutions can offer account holders embedded life insurance, increased financial security, and innovative deposit products

New York, New York–(Newsfile Corp. – September 17, 2024) – Wysh Life and Health Insurance Company, an AM Best A- rated insurance carrier offering innovative financial protection solutions, today announced that its embedded Life Benefit product is now accessible through the Jack Henry™ digital banking platform.

Wysh leveraged the Banno Digital Toolkit™, the same set of APIs the Banno Digital Platform™ is built on, to embed its technology into the digital experiences offered by community and regional financial institutions. Access to Jack Henry’s API, design, and authenticated frameworks has enabled Wysh to directly integrate Life Benefit into the digital banking platform, providing a seamless banking experience. This integration contributes to Jack Henry’s growing ecosystem of over 1,000 fintechs, providing approximately 7,500 financial institutions with relevant financial products and services for their account holders.

Life Benefit is a groundbreaking solution that embeds micro life insurance coverage equal to 10% of an account holder’s deposits, up to $10,000, providing protection directly to their account upon the holder’s death. With no opt-in, sign-up, or underwriting required, Life Benefit extends life insurance protection to demographics that have been historically overlooked due to pre-existing conditions or adverse financial histories. This innovative product helps banks and credit unions attract diverse, younger members, address net interest margin compression, and create new revenue streams through embedded affiliate programs.

“We’re thrilled to join Jack Henry’s fintech ecosystem and bring Life Benefit to more banks, credit unions and their members,” said Alex Matjanec, CEO of Wysh. “Our experience with the Banno Digital Toolkit has been excellent, allowing us to seamlessly integrate our solution into the digital banking platform. This collaboration will enable community and regional financial institutions to offer a truly innovative and inclusive financial protection product that aligns with their values while improving deposit economics.”

About Jack Henry™

Jack Henry™ (NASDAQ: JKHY) is a well-rounded financial technology company that strengthens connections between financial institutions and the people and businesses they serve. We are an company that prioritizes openness, collaboration, and user centricity – offering banks and credit unions a vibrant ecosystem of internally developed modern capabilities as well as the ability to integrate with leading fintechs. For more than 48 years, Jack Henry has provided technology solutions to enable clients to innovate faster, strategically differentiate, and successfully compete while serving the evolving needs of their account holders. We empower approximately 7,500 clients with people-inspired innovation, personal service, and insight-driven solutions that help reduce the barriers to financial health. Additional information is available at www.jackhenry.com.

About Wysh Life and Health Insurance Company

Wysh Life and Health Insurance Company is a wholly-owned subsidiary of Northwestern (NASDAQ:) Mutual. Wysh offers innovative embedded protection solutions, including Life Benefit, which helps financial institutions attract, retain, and differentiate deposits while providing valuable coverage to members. By integrating seamlessly with financial platforms, Wysh is revolutionizing the way financial institutions approach member protection and deposit growth. To learn more about Wysh, visit wysh.com or contact press@wysh.com.

###

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/223633

Continue Reading

Stock Markets

Fifth Third Community Development Corp. President Susan E. Thomas Named Co-Chair of National Housing Crisis Task Force

letizo News

Published

on

CINCINNATI–(BUSINESS WIRE)–A new bipartisan task force is tackling one of America’s most pressing problems “ the national housing crisis “ and is seeking to elevate the most innovative solutions from across the country to produce and preserve housing across all income levels in every part of the country.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240917284773/en/

Fifth Third Community Development Corporation President Susan E. Thomas (Photo: Business Wire)

This work will be led in part by Fifth Third Community Development Corporation President Susan E. Thomas, a national leader in community development banking and development. Of the four bipartisan National Housing Crisis Task Force co-chairs, Thomas is the only co-chair from the private sector.

The other co-chairs are Utah Governor Spencer Cox, Atlanta Mayor Andre Dickens, and Cleveland Mayor Justin M. Bibb.

The solutions are out there, but they are being deployed piecemeal, in individual communities, Thomas said. The task force will identify the best examples of innovative financing and land disposition tools, policies to streamline market-rate and subsidized-affordable housing development and help replicate them in communities across the country.

Thomas has seen firsthand the impact of innovation in housing through her work with Fifth Third’s Empowering Black Futures Neighborhood Program, which creates and implements innovative place-based strategies to effect positive change in nine historically disinvested neighborhoods across the Bank’s 11-state footprint.

Affordable housing is a cornerstone of Fifth Third’s Neighborhood Program, which is pioneering a new way to do community development by partnering with local organizations to build ecosystems that drive real change through both financial and social investments. This collective ecosystem approach is focused on identifying solutions to key challenges in partnership with the community, with the goal of creating lasting, transformative change.

At Fifth Third, we view safe, affordable housing as a basic human right, and helping to solve this crisis is one of our top priorities, said Kala Gibson, chief corporate responsibility officer for Fifth Third. As a regional bank, we are deeply embedded within the communities we serve, and we see firsthand every day how housing security is connected to economic mobility, financial stability, improved health outcomes and economic mobility.

Fifth Third’s Community Development Banking Group is actively helping to create housing inventory and remove barriers to affordability across the Bank’s footprint. This includes investing in low-income housing tax credits, new markets tax credits, community development financial institutions, and investment funds, as well as community-based lending for projects that create housing and provide other supportive services.

In 2023, Fifth Third provided $722 million in loans and investments to support 3,684 units of housing “ and we’re just getting started, Thomas said.

The National Housing Crisis Task Force is an ambitious, two-year project to bring the most promising innovations in housing production, preservation, and finance to communities across the country. Supported by the Nowak Metro Finance Lab at Drexel University and Accelerator for America (AFA), the bipartisan task force includes 28 government, non-profit, and business leaders who will create a platform to share and replicate what’s working locally, nationally and internationally. The task force’s work was launched Tuesday, July 23 at an in-person meeting in Washington, D.C. Its first report is expected this fall.

About Fifth Third

Fifth Third is a bank that’s as long on innovation as it is on history. Since 1858, we’ve been helping individuals, families, businesses and communities grow through smart financial services that improve lives. Our list of firsts is extensive, and it’s one that continues to expand as we explore the intersection of tech-driven innovation, dedicated people and focused community impact. Fifth Third is one of the few U.S.-based banks to have been named among Ethisphere’s World’s Most Ethical Companies ® for several years. With a commitment to taking care of our customers, employees, communities and shareholders, our goal is not only to be the nation’s highest performing regional bank, but to be the bank people most value and trust.

Fifth Third Bank, National Association is a federally chartered institution. Fifth Third Bancorp (NASDAQ:) is the indirect parent company of Fifth Third Bank and its common stock is traded on the NASDAQ ® Global Select Market under the symbol “FITB.” Investor information and press releases can be viewed at www.53.com. Deposit and credit products provided by Fifth Third Bank, National Association. Member FDIC.

Amanda Nageleisen (Media Relations)
amanda.nageleisen@53.com

Matt Curoe (Investor Relations)
matt.curoe@53.com | 513-534-2345

Source: Fifth Third

Continue Reading

Trending

©2021-2024 Letizo All Rights Reserved