Argatroban

DESyne BDS Plus system with site-specific antithrombotic therapeutic (TRx) significantly reduced the risk of TLF versus conventional drug-eluting stent through 12-months First site-specific antithrombotic therapeutic with two anticoagulants and an anti-proliferative mTOR inhibitor designed to reduce the burden of managing ischemic and thrombotic risk in cardiovascular interventions PARIS--(BUSINESS WIRE)-- Elixir Medical, a developer of transformative technologies to treat cardiovascular and peripheral disease, today announced significant positive 12-month clinical data from the DESyne BDS Plus Randomized Controlled Trial (RCT) evaluating DESyne BDS Plus, the world’s first triple drug-eluting coronary implant with site-specific antithrombotic therapeutic (TRx) coating versus a contemporary, durable polymer drug-eluting stent (DES). The data demonstrated a statistically significant lower TLF rate with DESyne BDS Plus than contemporary DES. The data were presented at a late-breaking clinical session during the EuroPCR 2024 conference in Paris. “The current standard of care of combining oral antithrombotic therapies continues to pose serious challenges, especially in patients who are at high thrombotic risk and high bleeding risk, as managing the tradeoff between ischemic and bleeding risks is logistically unsustainable for healthcare providers and often results in delay of essential treatment decisions,” said Alexandre Abizaid, M.D., Ph.D., interventional cardiologist at Instituto do Coração (InCor) in Sao Paulo, Brazil. “These exciting results from the DESyne BDS Plus RCT demonstrate the sustained superiority in safety and efficacy of DESyne BDS Plus compared to a standard of care DES and underscore the potential for site-specific anti-thrombotic therapeutic (TRx) as a promising solution that effectively addresses the compromises we have to make between bleeding and thrombosis when using systemic drug therapies.” 12-month clinical results demonstrated safety and efficacy of DESyne BDS Plus: Significantly lower TLF rate of 2.1% for DESyne BDS Plus compared to 9.3% for contemporary DES, p=0.03. No definite or probable stent thrombosis, cardiovascular death, or target vessel myocardial infarction (TV-MI), were observed in DESyne BDS Plus treated patients Previously presented data found that the study’s primary endpoint was met (pnon-inferiority<0.001); TLF at day three or at hospital discharge, whichever came first, which was 0.0% for DESyne BDS Plus treated patients versus 5.0% for patients treated with the contemporary durable polymer DES. DESyne BDS Plus has a bioresorbable coating containing three drugs: two anticoagulants (rivaroxaban and argatroban) and an antiproliferative mTOR inhibitor (sirolimus) designed for delivery of site-specific antithrombotic therapeutic. The coronary implant with TRx therapeutic is designed to reduce thrombotic risk while eliminating the negative side effect of bleeding associated with oral anti-thrombotic use and to effectively help address the challenge of logistically managing ischemic and bleeding risk in at-risk PCI patient populations. “We are thrilled with the statistically significant 12-month clinical outcomes of the TRx platform validating the improved safety and effectiveness of site-specific TRx therapeutic for coronary PCI treatment,” said Motasim Sirhan, CEO of Elixir Medical. “Site-specific antithrombotic therapy can be a more effective approach to addressing ischemic risk without the risk and complications of bleeding associated with oral anti-thrombotics.” Coronary artery disease is the leading cause of death for men and women in most racial and ethnic groups in the U.S.1 While PCI has positively impacted mortality rates,2 procedure and device related risks remain. Stent thrombosis after PCI is associated with large territory myocardial infarction (MI) events and poor outcomes, with death rates as high as 50% for early (<30 days) thrombosis cases.3 Management of ischemic and thrombotic risk requires medication adherence, but only 60% of patients are adherent to their prescribed cardiovascular medications which can lead to an increased risk of cardiovascular events or mortality by 20% or 35%, respectively.4 In addition, 3.5% of patients undergo non-cardiac surgery within six months of PCI procedure requiring careful management of thrombotic and bleeding risk by healthcare providers.5 About the DESyne BDS Trial The DESyne BDS Plus Randomized Clinical Trial (RCT) is a prospective, multicenter, single-blind study evaluating the safety, effectiveness, and performance of the DESyne BDS Plus Triple Drug-Eluting Coronary Implant compared to DESyne X2 Drug-Eluting Coronary Stent System in the treatment of de novo native coronary artery lesions. The trial includes 202 patients across 14 sites in Europe, New Zealand, and Brazil. An imaging subset of 58 patients had angiographic and optical coherence tomography (OCT) assessment completed in the first six months. Data collection will continue through three years. About TRx TRx is the world’s first triple-drug site-specific antithrombotic therapeutic using two anticoagulants (rivaroxaban and argatroban) and an antiproliferative mTOR inhibitor, sirolimus. The therapy was designed to address challenges associated with oral anti-thrombotics requiring a compromise between ischemic and bleeding risk, making it difficult and unsustainable for healthcare providers to manage patient needs. About Elixir Medical Elixir Medical Corporation, a privately-held company based in Milpitas, California, develops disruptive platforms to treat coronary and peripheral artery disease. Our technologies have multiple applications across the cardiovascular space capable of delivering improved clinical outcomes for millions of patients. Visit us at and on LinkedIn and X. References: Heart Disease Facts | CdC.gov. (2023, May 15). Centers for Disease Control and Prevention. Liza Chacko, James P. Howard, Christopher Rajkumar, Alexandra N. Nowbar, Christopher Kane, Dina Mahdi, Michael Foley, Matthew Shun-Shin, Graham Cole, Sayan Sen, Rasha Al-Lamee, Darrel P. Francis and Yousif Ahmad, Effects of Percutaneous Coronary Intervention on Death and Myocardial Infarction Stratified by Stable and Unstable Coronary Artery Disease: A Meta-Analysis of Randomized Controlled Trials, Cardiovascular Quality and Outcomes. 2020 Lawton et al. 2021 ACC/AHA/SCAI Coronary Revascularization Guideline. Chen Chen, MD, 1 Xiaoqing Li, MD, 1 Yuhao Su, MD, 1 Zhigang You, MD, PhD, 1 Rong Wan, PhD, 2 and Kui Hong, MD, PhD. Adherence with cardiovascular medications and the outcomes in patients with coronary arterial disease: “Real‐world” evidence. Clinical Cardiology. September 18, 2022. Smilowitz et al. Risks of Non-Cardiac Surgery Early after Percutaneous Coronary Intervention. Am Heart J. 2019 November; 217: 64–71. View source version on businesswire.com: Contacts Emma Yang, Health+Commerce Email: emma@healthandcommerce.com Source: Elixir Medical Corporation View this news release online at:

As early adopters of innovative robotic technology, Hackensack Meridian Health is selected as one of only 14 hospitals in the world to launch the da Vinci 5 surgical robot HACKENSACK, N.J., April 9, 2024 /PRNewswire/ -- Hackensack Meridian Hackensack University Medical Center, a center of excellence and an international leader in robotic-assisted surgery, was selected to be one of only 14 centers in the world, and the only in New Jersey, New York and Connecticut, to acquire the Intuitive Surgical da Vinci 5 multiport surgical system. With more than 10,000 times the computing power and the first-of-its-kind force-sensing technology, the da Vinci 5 is the most advanced surgical technology available. Continue Reading Hackensack Meridian Hackensack University Medical Center Among First Hospitals in the World To Acquire and Use the Da Vinci 5 Multiport Robotic Surgical System The Hackensack University Medical Center team performed the first procedures ever using the new system to treat the four patients on Monday, April 1, 2024. Da Vinci 5 builds on Intuitive's da Vinci Xi's highly functional design, which surgeons and care teams around the world have used in more than 7 million procedures to date. The system includes more than 150 enhancements, including: Enhanced precision and control: Da Vinci 5's design and engineering enhancements, including new surgeon controllers and powerful vibration and tremor controls, make it the smoothest and most precise system Intuitive has developed to date, helping surgeons maintain comfort during long procedures and potentially reduce fatigue. Next-generation 3D display and image processing: Da Vinci 5 is equipped with Intuitive's highest quality and most natural 3D imaging system, enabling surgeons to see more today, and supporting future generations of surgical endoscopes and vision software as those technologies evolve. First-of-its-kind force-sensing technology: Da Vinci 5 introduces Force Feedback technology and optional instruments that enable the system to measure, and surgeons to feel, subtle forces exerted on tissue during surgery —something no other surgical technology in any modality offers. In preclinical trials with surgeons at all experience levels, Force Feedback demonstrated up to 43 percent less force exerted on tissue, which may translate to less trauma on tissue. The ability to measure this force adds an important new data stream to surgical data science, which can bring future analytical insights supported through artificial intelligence. Force Feedback instruments, which are optional for use with da Vinci 5, are cleared for use in the same procedures as da Vinci Xi, except pediatric and cardiac procedures, and a specific contraindication for the Force Feedback needle driver for use in suturing during hysterectomy and myomectomy procedures. Streamlined workflow: Da Vinci 5 has innovative features that are designed to help increase surgeon autonomy and streamline surgeon and care team workflow. For example, da Vinci 5 has integrated key OR technologies, including insufflation and an electrosurgical unit. The system also includes an optimized user interface, with settings that are accessible by the broader surgical team and by the surgeon directly from the head-in menu. Surgeons have access to other key settings while head-in to help them stay focused on the surgical field. Together, these innovations will continue to streamline workflow in the OR and potentially save valuable time, without compromising patient safety. This can enable more efficient use of a hospital's human and capital resources. Expanded computing power and advanced data capabilities: Da Vinci 5 has more than 10,000 times the computing power of da Vinci Xi. This enables innovative new system capabilities and advanced digital experiences, now and in the future, including integration with Intuitive's My Intuitive app, SimNow (virtual reality simulator), Case Insights (computational observer), and Intuitive Hub (edge computing system). "The da Vinci 5 will allow us to take robotic surgery to the next level and expand on our long history of innovation and excellence," said Michael D. Stifelman, Chair of Urology and Director of Robotic Surgery at Hackensack University Medical Center, and Professor and Founding Chair of Urology at Hackensack Meridian School of Medicine. "We have been early adopters of the latest robotic technology for many years, and our goal has always been to offer our patients the highest quality surgical care that exceeds national standards. The da Vinci 5 is one more tool that we can use to deliver those results." Since Hackensack University Medical Center performed its first robotic-assisted surgery more than 20 years ago, the hospital has been at the forefront of robotic technology, continuously pushing the envelope to improve patient care through innovation, research and education. Robotic surgery innovations and "firsts" include: Robotic surgery began at Hackensack University Medical Center in 2000 with two da Vinci™ robots. First in New Jersey and New York Metropolitan Area to perform robotic-assisted gallbladder surgery using the da Vinci Si HD Surgical System (2012). Among the first hospitals in the world to acquire the da Vinci Single Port Robotic System (2018). Among the first in the northeast to implement surgical telepresence technology using the da Vinci Single Port system (2022). Becoming the first hospital in the nation to perform 1,000 single port robotic surgery procedures (2023). Perform 25,000 robotic surgeries - putting the Hackensack University Medical Center in the top 1% of hospitals in the country that have achieved this milestone (2023). "Across our network, we are committed to using the most advanced technology to improve the surgical experience for our patients," said Robert C. Garrett, FACHE, CEO of Hackensack Meridian Health. "The da Vinci 5 represents the next chapter in our robotic surgery journey, and we are proud to be among the first in the world to offer this game-changing robotic surgery option to our patients." The da Vinci 5 system will be used by surgeons in the fields of Gynecology, Urology, Thoracic, General Surgery, Barriatrics and Colorectal. The system is housed in the hospital's Helena Theurer Pavilion on the campus of Hackensack University Medical Center. The Pavilion is a state of the art nine-story surgical care tower - one of the largest and most advanced hospital expansions in the nation - it opened to the public in January of 2023 and embodies the mission of Hackensack Meridian Health - to use the latest technology to transform healthcare and to be the leader of positive change. "At Hackensack Meridian Health, we are continually investing in technology that benefits our patients, advances our capabilities and enhances the care we provide," explained Mark D. Sparta, FACHE, President & Chief Hospital Executive of Hackensack University Medical Center and President, North Region, Hackensack Meridian Health. "Our reputation for robotic surgery excellence, combined with our team's commitment to advancing robotic surgery, has enabled us to be among the first in the world to acquire and use the da Vinci 5, and that translates to increased robotic surgery options and access for patients in the communities we serve." Patients may experience benefits that include: Decreased blood loss and reduced need for transfusions Less risk of infection Less pain after surgery Smaller external and internal scars Shorter hospital stay Faster recovery ABOUT HACKENSACK UNIVERSITY MEDICAL CENTER Hackensack University Medical Center, an 803-bed nonprofit teaching and research hospital, was Bergen County's first hospital founded in 1888. It is also the first hospital in New Jersey and third in the nation to become a Magnet®-recognized hospital for nursing excellence, receiving its seventh consecutive designation from the American Nurses Credentialing Center in 2024. The academic flagship of the Hackensack Meridian Health network, Hackensack University Medical Center is the #1 hospital in New Jersey according to the U.S. News & World Report's 2022-2023 Best Hospitals list. In addition to being ranked the top hospital in New Jersey, Hackensack University Medical Center is ranked #6 overall in the New York Metropolitan area as well as being home to the John Theurer Cancer Center, a premier cancer center in New Jersey. Hackensack University Medical Center has the best, nationally-ranked programs in New Jersey in Cardiology, Heart & Vascular Surgery (#42), Pulmonology and Lung Surgery (#24), and Geriatrics (#36). It is also the only New Jersey hospital nationally ranked in Neurology and Neurosurgery (#22) and Urology (#27). The hospital is also nationally ranked in Orthopedics (#33). Hackensack University Medical Center is also recognized for 18 high-performing procedures and conditions. Named to Newsweek's World's Best Hospitals 2024 list, Hackensack University Medical Center is also the recipient of the 2023 Patient Safety Excellence Award™ by Healthgrades as well as an "A" Hospital Safety Grade from The Leapfrog Group. This award-winning care is provided on a campus that is home to facilities such as the Heart & Vascular Hospital; and the Sarkis and Siran Gabrellian Women's and Children's Pavilion, which houses the Donna A. Sanzari Women's Hospital and the Joseph M. Sanzari Children's Hospital, ranked #1 in the state and top 20 in the Mid-Atlantic Region in the U.S. News & World Report's 2022-23 Best Children's Hospital Report. Hackensack University Medical Center is listed on the Green Guide's list of Top 10 Green Hospitals in the U.S. The hospital's comprehensive clinical research portfolio includes studies focused on precision medicine, translational medicine, immunotherapy, cell therapy, and vaccine development. In 2023, the hospital completed the largest healthcare expansion project ever approved by the state: construction of the Helena Theurer Pavilion, a 530,000-sq.-ft., nine-story building housing 24 state-of-the-art operating rooms with intraoperative MRI capability, 50 ICU beds, and 175 medical/surgical beds including a 50 room Musculoskeletal Institute. SOURCE Hackensack University Medical Center