Paralysis

30-Day Data from Endospan's NEXUS TRIOMPHE IDE Trial Demonstrate 63% Reduction in Major Adverse Event (MAE) Rate compared with Reference Performance Goal ATLANTA, May 5, 2025 /PRNewswire/ -- Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced the presentation of new clinical data from Endospan's NEXUS TRIOMPHE trial at the 105th American Association for Thoracic Surgery (AATS) Annual Meeting in Seattle, Washington. The data presented analyzed clinical outcomes across a 54-patient chronic aortic dissection statistical cohort at 30 days following treatment with NEXUS. Patients enrolled were at high risk for open surgical repair. Dr. Bradley Leshnower, Professor of Surgery and Director of Thoracic Aortic Surgery, Emory University, presented the data from the NEXUS US IDE trial in an abstract titled, Endovascular Aortic Arch Repair Using a Novel Single-Branch Arch Stent Graft for Chronic Dissection: 30-Day Outcomes of the TRIOMPHE FDA Pivotal Study. The data demonstrate statistically significant improvement in clinical outcomes and device technical performance compared with the performance goals set forth in the FDA-approved investigational device exemption (IDE). *Major adverse events (MAEs) = mortality, disabling stroke, permanent paralysis/paraplegia, renal failure, aortic rupture, or development of new dissections in the thoracic aorta or brachiocephalic artery requiring intervention. Dr. Leshnower said, "The 30-day results from the TRIOMPHE study demonstrate that aneurysms due to chronic aortic arch dissection involving the aortic arch can be successfully treated with this novel off-the-shelf stent graft system. The NEXUS device provides an excellent, minimally invasive alternative to open aortic arch replacement in select patients at high risk for open surgery. This novel technology will extend treatment to patients who previously would not be offered therapy due to prohibitive risk" "We are pleased with the 30-day results and look forward to seeing the one-year outcomes," said Pat Mackin, Chairman, President and Chief Executive Officer of Artivion. "These results further validate this important therapeutic option for patients with aortic arch disease." About the NEXUS TRIOMPHE Clinical Trial The NEXUS TRIOMPHE trial is the US IDE study evaluating the NEXUS device in the endovascular treatment of chronic aortic dissection, either primary type B or residual dissection after prior type A repair, or aneurysm (not reported here). Inclusion criteria include the patient being high risk for open surgical repair. The clinical module of the PMA is anticipated to be filed after completion of one year of follow up with the 54 patients in the chronic aortic dissection statistical primary cohort. About Artivion, Inc. Headquartered in suburban Atlanta, Georgia, Artivion, Inc., is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion's four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion markets and sells products in more than 100 countries worldwide. For additional information about Artivion, visit our website, . References Leshnower B: Endovascular Aortic Arch Repair Using a Novel Single-Branch Arch Stent Graft for Chronic Dissection: 30-Day Outcomes of the TRIOMPHE FDA Pivotal Study. Presented May 3, 2025 at American Association of Thoracic Surgeons 105th annual meeting. Contacts: SOURCE Artivion, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Three Senate Democrats asked the Federal Trade Commission to investigate whether neurotechnology companies are engaging in unfair or deceptive practices. \n Three Senate Democrats called for an investigation into the developers of brain-computer interface devices, including healthcare and consumer tech products, to make sure the information they collect is properly safeguarded—and not simply sold for profit. “Unlike other personal data, neural data—captured directly from the human brain—can reveal mental health conditions, emotional states, and cognitive patterns, even when anonymized,” wrote Sens. Chuck Schumer, New York; Maria Cantwell, Washington; and Ed Markey, Massachusetts, in a letter (PDF) to the chair of the Federal Trade Commission (FTC), Andrew Ferguson. “This information is not only deeply personal; it is also strategically sensitive.”The senators cited a 2024 review (PDF) conducted by the Neurorights Foundation into the published privacy practices of 30 different companies and their consumer-focused, noninvasive products—ranging from the makers of EEG-equipped headbands that connect with wellness and meditation apps to the developers of a medically approved therapy for depression.  The report found that most of the companies’ user agreements include provisions that allow them to share the data they collect with third parties, often without clear consent.At the same time, the foundation said international legal standards regarding the protection of neural data may be ambiguous: Because the capturable inner workings of the brain are inherently electrical, they may fall through a loophole in statutes that define “biological data” as information gathered from a person’s DNA or diagnostic samples—while “biometric data” laws typically cover fingerprints or retinal scans.“Americans neural data must not be reposted or transferred without fully informed opt-in consent,” the senators wrote. “If an individual uses a BCI device for medical or cognitive support, they should not later learn their brain signals trained an AI system or were sold to third parties. And, we must ensure that Americans’ neural data is never transferred to foreign adversaries.”The senators’ letter names Elon Musk’s Neuralink as an example of a company working on brain-to-device communication. Neuralink was not included in the Neurorights Foundation’s report, and, as a company currently developing its system as a medical device for people with paralysis, its data collection practices would fall under HIPAA as well as federal regulations governing clinical trials of human subjects. The senators asked the FTC to investigate whether neurotechnology companies are engaging in unfair or deceptive practices, and urged the agency to compel reporting on data handling practices across the BCI sector—with an added focus on products used by teens and children.As the market expands, companies across the spectrum—from wellness apps to advanced medical implant developers—are collecting neural signals that may be repurposed beyond their stated use, they wrote. “More needs to be done to address the unique risks, sensitivities, and potential misuse associated with neural data across this broader landscape.” At the state level, laws were signed in Colorado and California last year that added neural data to the lists of personal and sensitive information afforded protection under consumer privacy acts—placing brain activity alongside the recordings of facial images, DNA and fingerprints. 

MANHASSET, N.Y.--(BUSINESS WIRE)--Inflammation is the body’s response to injury and infection. To better understand how the body’s nerves and neurons detect inflammation, researchers at Northwell Health’s Feinstein Institutes for Medical Research have shown how vagus nerve immune signals are encoded and communicated to the brain and how inflammation caused by conditions like colitis can disrupt this neuro-immune signaling. The study, led by Eric H. Chang, PhD, associate professor in the Institute of Bioelectronic Medicine at the Feinstein Institutes, and published this week in Nature Communications, focuses on sensory neurons of the vagus nerve, a major communication pathway between the body and the brain. The researchers used advanced calcium imaging techniques to observe the activity of individual sensory neurons within the nodose ganglion, a cluster of nerve cells that forms part of the vagus nerve. They found that different inflammatory signals, called cytokines, activate distinct patterns of neural activity in individual neurons. Some neurons respond selectively to only one cytokine, while others respond to multiple cytokines but maintain the unique cytokine-specific activity signatures. While it was previously known that cytokines are released in the body during inflammation, how the nervous system detects and represents these immune signals was unclear. “This research unveils a previously unrecognized complexity in how sensory neurons in the peripheral nervous system of the body communicate immune signals to the brain,” said Dr. Chang. “It provides insights about the precise neural mechanisms used to encode immune information, offering potential new avenues to diagnose and treat disorders of the neuro-immune axis.” The researchers also discovered that inflammation caused by colitis alters the activity of these sensory neurons. Inflammation increases the baseline activity of these neurons but reduces their ability to respond precisely to specific cytokines. In other words, inflammation “scrambles” the neuro-immune nerve signals, potentially disrupting how the brain regulates the immune response and contributing to conditions such as autoimmune disease and chronic inflammatory disorders. “The brain controls the amount of inflammation in the body, and nerves in the body inform the brain about the extent of inflammation,” said Kevin J. Tracey, MD, president and CEO of the Feinstein Institutes and Karches Family Distinguished Chair in Medical Research. “The discoveries in this important paper reveal how the vagus nerve transmits specific electrical signals to the brain about inflammation in a gut-vagus-brain axis.” The Feinstein Institutes for Medical Research is the global scientific home of bioelectronic medicine, which combines molecular medicine, neuroscience and biomedical engineering. At the Feinstein Institutes, medical researchers use modern technology to develop new device-based therapies to treat disease and injury. Building on years of research in molecular disease mechanisms and the link between the nervous and immune systems, Feinstein Institutes’ researchers discovered neural targets that can be activated or inhibited with neuromodulation devices, like vagus nerve implants, to control the body's immune response and inflammation. If inflammation is successfully controlled, diseases – such as arthritis, pulmonary hypertension, heart failure, inflammatory bowel diseases, diabetes, cancer and autoimmune diseases – can be treated more effectively. Beyond inflammation, using novel brain-computer interfaces, Feinstein Institutes' researchers developed techniques to bypass injuries of the nervous system so that people living with paralysis can regain sensation and use their limbs. By producing bioelectronic medicine knowledge, disease and injury could one day be treated with our own nerves without costly and potentially harmful pharmaceuticals. About the Feinstein Institutes The Feinstein Institutes for Medical Research is the home of the research institutes of Northwell Health, the largest health care provider and private employer in New York State. Encompassing 50+ research labs, 3,000 clinical research studies and 5,000 researchers and staff, the Feinstein Institutes raises the standard of medical innovation through its six institutes of behavioral science, bioelectronic medicine, cancer, health system science, molecular medicine, and translational research. We are the global scientific leader in bioelectronic medicine – an innovative field of science that has the potential to revolutionize medicine. The Feinstein Institutes publishes two open-access, international peer-reviewed journals Molecular Medicine and Bioelectronic Medicine. Through the Elmezzi Graduate School of Molecular Medicine, we offer an accelerated PhD program. For more information about how we produce knowledge to cure disease, visit http://feinstein.northwell.edu and follow us on LinkedIn.