Latest news with #Trial
Yahoo
21-05-2025
- Health
- Yahoo
EuroPCR 2025: Late-Breaking Data Demonstrate Sustained Significantly Lower Event Rates With Elixir Medical's DynamX Bioadaptor Over Drug-Eluting Stent Through Three Years
Paris, May 21, 2025 (GLOBE NEWSWIRE) -- —Sustained durability of treatment effect with significantly lower TLF rates (2.7% versus 7.2%, p=0.030) with DynamX® compared to DES— —Significantly lower rate of Cardiac Death (0.5% versus 3.2%, p=0.033) with DynamX® compared to DES— Paris – May 21, 2025 – Elixir Medical, a developer of transformative technologies to treat cardiovascular and peripheral disease, today announced three-year results from the large 445-patient BIOADAPTOR Randomized Controlled (1:1) Trial (RCT), comparing the DynamX® Coronary Bioadaptor System to standard of care Resolute OnyxTM Drug-Eluting Stent (DES) from 34 centers in Japan, Europe, and New Zealand. The results demonstrate sustained very low adverse events and durability of clinical outcomes with DynamX® bioadaptor in target lesion failure (TLF) and Cardiovascular Death (CVD) compared to non-plateauing increase in adverse events in the DES arm. The data were presented at a late-breaking clinical session during the EuroPCR 2025 conference in Paris. Clinical results show sustained significant reduction of device-oriented adverse events with DynamX® bioadaptor over the drug-eluting stent at three years: Significant reduction in TLF rate (2.7% versus 7.2%; p=0.030) demonstrating the durability of DynamX® treatment through three years of follow-up. The significant reduction in TLF was driven by low adverse events across all components of the composite endpoint with DynamX® compared to DES, respectively: Significantly lower Cardiovascular Death (0.5% versus 3.2%, p=0.033) Target Vessel Myocardial Infarction (0.9% versus 1.8%) Ischemia-Driven Target Lesion Revascularization (1.4% versus 2.7%) Reduction in adverse events amplified in Left Anterior Descending (LAD) artery lesions: Significantly lower TLF rate in LAD lesions (2.7% versus 10.6%; p=0.019) consistent with bioadaptor mechanism of action of restoring vessel function in this hemodynamically critical coronary vessel as reported previously in the imaging subgroup at 12 months1. 'These three-year results from the BIOADAPTOR RCT demonstrate that DynamX bioadaptor provides for a new class of treatment—with significant clinical benefit from six months when the bioadaptor mechanism of action is activated and sustained through long-term follow-up, including the hard clinical endpoint of cardiovascular death,' said Shigeru Saito, M.D., director of the Division of Cardiology and Catheterization Laboratory at Shonan Kamakura General Hospital in Kamakura, Japan. 'We also see the heightened importance of restoring hemodynamic modulation in the LAD vessel demonstrated by the large difference in clinical events in LAD lesions between the two treatment arms.' The DynamX bioadaptor is differentiated from the current therapies, having a novel mechanism of action designed to return vessel health through three distinct phases of adapting in the body to restore vessel biology. In the locked phase during the implant, the bioadaptor opens the artery and restores blood flow. Unique to bioadaptor, after six months the implant unlocks, separates into three helical strands, releasing the vessel and providing dynamic support to maintain the established blood flow lumen. The continued adaptive dynamic support helps return vessel hemodynamic modulation through restoration of pulsatility and adaptive blood flow volume and has also shown evidence of plaque stabilization and regression in the lesion. 'With these results, we are pleased to demonstrate that restoring hemodynamic modulation of the artery translates to lasting clinical outcomes, elevating the level of care for patients,' said Motasim Sirhan, CEO of Elixir Medical. 'With the three-year BIOADAPTOR-RCT data presented today, and the results from the 2,400 patient INIFINITY-SWEDEHEART RCT published in The Lancet, we have shown consistently across multiple trials significantly lower, plateauing clinical events after six months with DynamX® bioadaptor compared to DES, validating the benefit of our transformative technology.' About BIOADAPTOR RCT TrialThe BIOADAPTOR RCT is an international, single-blind, randomized controlled (1:1) trial comparing a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent in 445 patients in 34 centers in Japan, Europe, and New Zealand. Both arms had large randomized multi-modality imaging subgroups of 50 patients each to document standard effectiveness benchmarks of establishing and maintaining artery flow lumen measured by percent diameter stenosis (%DS) and late lumen loss (LLL), and the new effectiveness benchmarks of restoring artery hemodynamic modulation, including pulsatility, vessel compliance, adaptive flow volume, and plaque stabilization and regression. Clinical follow-up will continue through five years. BIOADAPTOR RCT trial is the third trial of Elixir Medical's robust DynamX® bioadaptor clinical evidence program consisting of nine company-sponsored and investigator-initiated studies involving over 9,000 patients, including INFINITY SWEDEHEART RCT (n=2400) and a global BIO-RESTORE registry with a target enrollment of up to 5,000 patients. About DynamX Coronary Bioadaptor SystemThe DynamX® bioadaptor is the first coronary implant technology designed to restore coronary artery hemodynamic modulation as demonstrated by restored vessel pulsatility, compliance, and adaptive increase in blood flow volume, and providing plaque stabilization and regression. With its unique mechanism of action (MOA), it addresses the shortcomings of drug-eluting stents and bioresorbable scaffolds (BRS) with remarkably low clinical event rates that showed a plateau from six months through three-year clinical follow-up. The DynamX® Coronary Bioadaptor System is CE-marked. The DynamX® Sirolimus Eluting Coronary Bioadaptor System is an investigational device. Limited by Federal (or United States) law to investigational use. About Elixir MedicalElixir Medical Corporation, a privately held company based in Milpitas, California, develops disruptive platforms to treat coronary and peripheral artery disease. Our transformative technologies have multiple applications across the cardiovascular space capable of delivering improved clinical outcomes for millions of patients. Elixir Medical was named to Fast Company's prestigious list of the World's Most Innovative Companies of 2025. Visit us at and on LinkedIn. Media ContactRichard LaermerRLM PRelixir@ 741-5106 X 216 1 Saito S et al. 12-Months Outcomes BIODAPTOR-RCT. The Lancet eClinicalMedicine. 2023;65: in to access your portfolio
Yahoo
21-05-2025
- Health
- Yahoo
EuroPCR 2025: Late-Breaking Data Demonstrate Sustained Significantly Lower Event Rates With Elixir Medical's DynamX Bioadaptor Over Drug-Eluting Stent Through Three Years
Paris, May 21, 2025 (GLOBE NEWSWIRE) -- —Sustained durability of treatment effect with significantly lower TLF rates (2.7% versus 7.2%, p=0.030) with DynamX® compared to DES— —Significantly lower rate of Cardiac Death (0.5% versus 3.2%, p=0.033) with DynamX® compared to DES— Paris – May 21, 2025 – Elixir Medical, a developer of transformative technologies to treat cardiovascular and peripheral disease, today announced three-year results from the large 445-patient BIOADAPTOR Randomized Controlled (1:1) Trial (RCT), comparing the DynamX® Coronary Bioadaptor System to standard of care Resolute OnyxTM Drug-Eluting Stent (DES) from 34 centers in Japan, Europe, and New Zealand. The results demonstrate sustained very low adverse events and durability of clinical outcomes with DynamX® bioadaptor in target lesion failure (TLF) and Cardiovascular Death (CVD) compared to non-plateauing increase in adverse events in the DES arm. The data were presented at a late-breaking clinical session during the EuroPCR 2025 conference in Paris. Clinical results show sustained significant reduction of device-oriented adverse events with DynamX® bioadaptor over the drug-eluting stent at three years: Significant reduction in TLF rate (2.7% versus 7.2%; p=0.030) demonstrating the durability of DynamX® treatment through three years of follow-up. The significant reduction in TLF was driven by low adverse events across all components of the composite endpoint with DynamX® compared to DES, respectively: Significantly lower Cardiovascular Death (0.5% versus 3.2%, p=0.033) Target Vessel Myocardial Infarction (0.9% versus 1.8%) Ischemia-Driven Target Lesion Revascularization (1.4% versus 2.7%) Reduction in adverse events amplified in Left Anterior Descending (LAD) artery lesions: Significantly lower TLF rate in LAD lesions (2.7% versus 10.6%; p=0.019) consistent with bioadaptor mechanism of action of restoring vessel function in this hemodynamically critical coronary vessel as reported previously in the imaging subgroup at 12 months1. 'These three-year results from the BIOADAPTOR RCT demonstrate that DynamX bioadaptor provides for a new class of treatment—with significant clinical benefit from six months when the bioadaptor mechanism of action is activated and sustained through long-term follow-up, including the hard clinical endpoint of cardiovascular death,' said Shigeru Saito, M.D., director of the Division of Cardiology and Catheterization Laboratory at Shonan Kamakura General Hospital in Kamakura, Japan. 'We also see the heightened importance of restoring hemodynamic modulation in the LAD vessel demonstrated by the large difference in clinical events in LAD lesions between the two treatment arms.' The DynamX bioadaptor is differentiated from the current therapies, having a novel mechanism of action designed to return vessel health through three distinct phases of adapting in the body to restore vessel biology. In the locked phase during the implant, the bioadaptor opens the artery and restores blood flow. Unique to bioadaptor, after six months the implant unlocks, separates into three helical strands, releasing the vessel and providing dynamic support to maintain the established blood flow lumen. The continued adaptive dynamic support helps return vessel hemodynamic modulation through restoration of pulsatility and adaptive blood flow volume and has also shown evidence of plaque stabilization and regression in the lesion. 'With these results, we are pleased to demonstrate that restoring hemodynamic modulation of the artery translates to lasting clinical outcomes, elevating the level of care for patients,' said Motasim Sirhan, CEO of Elixir Medical. 'With the three-year BIOADAPTOR-RCT data presented today, and the results from the 2,400 patient INIFINITY-SWEDEHEART RCT published in The Lancet, we have shown consistently across multiple trials significantly lower, plateauing clinical events after six months with DynamX® bioadaptor compared to DES, validating the benefit of our transformative technology.' About BIOADAPTOR RCT TrialThe BIOADAPTOR RCT is an international, single-blind, randomized controlled (1:1) trial comparing a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent in 445 patients in 34 centers in Japan, Europe, and New Zealand. Both arms had large randomized multi-modality imaging subgroups of 50 patients each to document standard effectiveness benchmarks of establishing and maintaining artery flow lumen measured by percent diameter stenosis (%DS) and late lumen loss (LLL), and the new effectiveness benchmarks of restoring artery hemodynamic modulation, including pulsatility, vessel compliance, adaptive flow volume, and plaque stabilization and regression. Clinical follow-up will continue through five years. BIOADAPTOR RCT trial is the third trial of Elixir Medical's robust DynamX® bioadaptor clinical evidence program consisting of nine company-sponsored and investigator-initiated studies involving over 9,000 patients, including INFINITY SWEDEHEART RCT (n=2400) and a global BIO-RESTORE registry with a target enrollment of up to 5,000 patients. About DynamX Coronary Bioadaptor SystemThe DynamX® bioadaptor is the first coronary implant technology designed to restore coronary artery hemodynamic modulation as demonstrated by restored vessel pulsatility, compliance, and adaptive increase in blood flow volume, and providing plaque stabilization and regression. With its unique mechanism of action (MOA), it addresses the shortcomings of drug-eluting stents and bioresorbable scaffolds (BRS) with remarkably low clinical event rates that showed a plateau from six months through three-year clinical follow-up. The DynamX® Coronary Bioadaptor System is CE-marked. The DynamX® Sirolimus Eluting Coronary Bioadaptor System is an investigational device. Limited by Federal (or United States) law to investigational use. About Elixir MedicalElixir Medical Corporation, a privately held company based in Milpitas, California, develops disruptive platforms to treat coronary and peripheral artery disease. Our transformative technologies have multiple applications across the cardiovascular space capable of delivering improved clinical outcomes for millions of patients. Elixir Medical was named to Fast Company's prestigious list of the World's Most Innovative Companies of 2025. Visit us at and on LinkedIn. Media ContactRichard LaermerRLM PRelixir@ 741-5106 X 216 1 Saito S et al. 12-Months Outcomes BIODAPTOR-RCT. The Lancet eClinicalMedicine. 2023;65: in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
20-05-2025
- Health
- Yahoo
Watch live: The Hill Talks – Breaking Down Financial Barriers to Clinical Trial Participation
Clinical trials are essential for evaluating potential new treatments, advancing the standard of care, and improving patient outcomes, yet only about five percent of Americans participate in them. As it stands, patients from lower-income and rural communities often face substantial economic barriers to participation, including lost wages, time, and out-of-pocket costs for transportation and lodging. What can Congress do to make clinical trials more accessible to patients? What are the biggest barriers to participation? And what does this all mean for the future of drug development? Join us for The Hill Talks: Breaking Down Financial Barriers to Clinical Trial Participation, a bipartisan program examining this issue with lawmakers and patient advocates with a critical focus on health equity. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
News24
18-05-2025
- General
- News24
John Kani on the NAF's celebration of his friends, Winston Ntshona and Athol Fugard
X Read this for free Be among those who shape the future with knowledge. Uncover exclusive stories that captivate your mind and heart with our FREE 14-day subscription trial. Dive into a world of inspiration, learning, and empowerment. You can only trial once. Start your FREE trial now
CNN
16-05-2025
- Entertainment
- CNN
Takeaways so far Cassie Ventura's 2nd day of cross-examination in Sean ‘Diddy' Combs trial
People in entertainment Sean 'Diddy' CombsFacebookTweetLink Follow The cross-examination of Cassie Ventura continued midday Friday as her time on the stand moved toward its end in Sean 'Diddy' Combs' racketeering and sex-trafficking trial. Ventura, Combs' former longtime girlfriend, who is the star witness in the case and is testifying for the fourth straight day Combs physically and sexually abused her and used violence and blackmail to make her participate in drug-fueled sex parties known as 'Freak Offs' over more than a decade. Under cross-examination, defense attorneys have asked about her own explicit messages with Combs about the 'Freak Offs,' whether Combs' staffers knew about the liaisons, and the role of jealousy and drugs in their relationship. The defense has acknowledged Combs has been violent with romantic partners and has a 'different' sex life. However, they have argued the women consented to these sexual arrangements and have attempted to portray Combs as a jealous man with a drug problem as opposed to the head of a criminal enterprise. Combs has pleaded not guilty to racketeering conspiracy, sex trafficking and transportation to engage in prostitution. He could face up to life in prison. Judge Arun Subramanian has announced plans to have Ventura's testimony fully finished before the weekend. Ventura is pregnant with her third child due next month, and prosecutors have expressed concern she could have the baby as soon as this weekend. Here's what we learned in her testimony Friday. Ventura testified that she saw Combs voluntarily at a friend's birthday a month after she says he raped her in August 2018. She said she still had feelings for him then and did not hate him at the time – or even now. 'I don't hate him,' Ventura testified. 'Do you still have love for him?' defense attorney Anna Estevao asked. 'I have love for the past and what it was,' Ventura said. To begin Friday, Estevao picked back up where she left off Thursday in questioning Ventura about the March 5, 2016, incident at a Los Angeles hotel in which Combs grabbed, kicked and dragged Ventura in an elevator lobby. Estevao asked Ventura if she told investigators in previous interviews that Combs was 'black out' during the incident. 'I believe he was intoxicated,' she testified, adding that everyone's perception of a 'black out' is different. The jury saw a message Ventura sent Combs five days after the assault describing the abuse and his state of mind. 'When you get f**ked up the wrong way you always want to show me that you have the power, and you knock me around. I'm not a rag doll, I'm someone's child,' she wrote in the message read aloud in court. Surveillance video of that assault has been the central evidence in this trial so far. CNN first published video of the incident last year. Ventura testified earlier this week that the hotel assault came after she tried to leave a 'Freak Off' before it was 'over.' Afterward, she had a 'black eye and a fat lip' and spoke to the police about the incident but 'wasn't ready' to name Combs, according to her testimony. The jury heard a recording Ventura captured of a conversation she had with a man in Atlantic City in March 2014 after the man said he'd seen a sexually explicit video of her. In the recording, she threatened the man multiple times. 'I will cut you up and put you in the f**king dirt right now if you have it,' she said. 'I'm going to kill you and then he's gonna kill you again.' 'I'm going to f**k you up, and it's not going to be my hands and it's not going to be blood on my hands. Someone else is going to do it,' she said in the recording. Ventura has previously told the jury that Combs pushed her to get to the bottom of the situation. Whether there actually was an explicit video of her or how the situation was resolved was not established in Ventura's testimony. Ventura also testified that she believed a man had secretly taken a video of her and Combs at a 'Freak Off.' She was concerned about it and told Combs, who responded that he'd 'take care of it,' she testified. Ventura and Combs dated on and off from 2007 to 2018, and Ventura offered her view on the end of the relationship. After the death of Kim Porter, the late model and actress who shared three children with Combs, Combs posted on social media that he and Porter were 'more than soulmates.' Around the time of her memorial service, Ventura texted Combs that it hurt her feelings. 'Then you posted that Kim was your soulmate, What was the 11 years all about,' she wrote. Porter's memorial service was the last time Ventura and Combs saw each other in person. 'He let you go?' Estevao asked her to confirm. 'I never saw him again. I don't know about letting me go,' she testified. Combs has tried to get in touch with her over the years since then, including through other people, Ventura said.
