Cedars-Sinai Medical Center

Ipsen’s elafibranor has shown promise as a treatment for primary sclerosing cholangitis (PSC), a rare liver disease that currently has no approved treatment options. Results from the phase 2 ELMWOOD study, which has been comparing two doses of the drug against placebo in 68 PSC patients, will be presented at this year’s European Association for the Study of the Liver congress. PSC is a chronic disease characterised by inflammation and scarring of the bile ducts, which can results in liver damage and eventually liver failure. Symptoms vary, but can include itching, fatigue, abdominal pain and jaundice, with patients also experiencing serious complications such as liver cirrhosis and an increased risk of liver cancer. Liver transplantation is currently the only treatment that can significantly improve the prognosis of PSC, underscoring the need for new approaches. Data from ELMWOOD demonstrated a positive safety and tolerability profile, the trial’s primary endpoint, for elafibranor-treated patients versus those receiving placebo. Efficacy benefits were also observed in the elafibranor groups. Patients receiving elafibranor experienced significant dose-dependent reductions in alkaline phosphatase at week 12 compared to placebo, with improvements seen as early as week four. Similar results were demonstrated in other biochemical liver parameters, Ipsen said, including alanine aminotransferase and gamma-glutamyl transferase, two key biochemical markers of disease progression. Additionally, elafibranor was associated with stabilisation in enhanced liver fibrosis compared to placebo at week 12, and patients receiving a 120mg dose of Ipsen’s drug experienced improvements in itch compared to those on placebo. Taken orally once daily, Iqirvo is a peroxisome proliferator-activated receptor agonist that decreases bile toxicity and improves cholestasis by modulating bile acid synthesis, detoxification and transporters. The drug recently gained approval in the US, EU and UK under the brand name Iqirvo to treat primary biliary cholangitis, another rare liver disease. Christelle Huguet, executive vice president and head of research and development at Ipsen, said the results from ELMWOOD “reinforce elafibranor’s action as a PPARα/δ agonist in potentially treating multiple liver diseases, like PSC”. An open-label 96-week extension study evaluating the safety and efficacy of elafibranor 120mg in PSC is ongoing.

Real-Time, 360-Degree Imaging Enhances Precision and Confidence in Cardiac Procedures DUBLIN, April 16, 2025 /PRNewswire/ -- LUMA Vision Ltd., an innovative leader in advanced cardiac imaging and navigation, today announced the FDA clearance of its VERAFEYE™ Visualization Platform. This novel catheter-based imaging system provides real-time, two and four-dimensional, 360-degree visualization, significantly enhancing clinician precision and confidence during complex electrophysiology and structural heart procedures. The system is prepared for magnetic tracking and navigation of third-party catheters, which in the future, will further empower clinicians to perform complex procedures with greater precision and control. The VERAFEYE system combines state-of-the-art imaging technology with advanced digital maneuverability, enabling clinicians to capture highly detailed, four-dimensional images that update in real time. With imaging depths up to 120 mm away from the catheter, it allows for dynamic high-resolution navigation and visualization of the heart, crucial to performing today's advanced electrophysiology and structural heart procedures with a wide variety of technologies. Traditional imaging catheters provide only two-dimensional imaging, often limiting clinicians' ability to view cardiac anatomy from all angles during procedures. The VERAFEYE catheter introduces a new era of intracardiac imaging, allowing for comprehensive, 360-degree visualization with enhanced depth and clarity. "Our clinical experience with VERAFEYE is exciting, with the potential to simplify procedural workflow and efficiency," said Dr. Shephal Doshi, Director of Electrophysiology at Pacific Heart Institute/Cedars Sinai and investigator of the VERAFEYE system. "Real-time visualization and rapid creation of cardiac anatomy can facilitate de novo procedures with greater simplicity." Fionn Lahart, CEO, at LUMA Vision, expressed excitement about the technology's potential: "We are incredibly proud of this achievement and the potential impact VERAFEYE will have in areas such as cardiac arrhythmias, left atrial appendage closure and structural heart. Our team and partners have worked tirelessly alongside clinicians to develop a product that can be the future of cardiac navigation, and this FDA clearance is a testament to their dedication and expertise. We look forward to seeing the positive difference VERAFEYE will make in the lives of patients and healthcare providers alike". The successful approval of the VERAFEYE system and catheter represents a significant step toward improving procedural workflows and broadening the potential for many of the innovative technologies that need precise visualization to deliver effective treatment. By providing real-time, volumetric images of the heart in combination with magnetic navigation, the interactive visualization of the VERAFEYE system enables clinicians to make more informed decisions, potentially reducing procedure time and minimizing risks. "The approval of VERAFEYE is a major advancement in intraprocedural cardiac imaging," said Dr. Anish Amin, System Medical Chief for Cardiac Electrophysiology, OhioHealth Heart and Vascular. "VERAFEYE's imaging capabilities demonstrate a necessary path forward in precision imaging and a strong foundation to further advance the standard of care." About LUMA Vision LUMA Vision is a privately held, medical device company based in Dublin, Ireland and Munich, Germany. LUMA Vision designs and develops cutting edge innovative technologies to significantly advance healthcare and solve truly global unmet clinical needs. VERAFEYE™ is a novel ultrasound based cardiac visualization and navigation platform for generating a 360-degree view, navigating and imaging all structures and devices around the catheter with an unprecedented field of view. With a commitment to advancing patient care, LUMA Vision focuses on delivering groundbreaking products that enhance clinical outcomes and improve lives around the world. LUMA Vision was founded by CEO Fionn Lahart and CTO Christoph Hennersperger. Learn more about LUMA Vision and VERAFEYE at SOURCE LUMA Vision WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The SP SureForm 45 instrument is built off the same technology as its multiport counterpart, including systems to monitor tissue compression before and during stapling. \n Intuitive has snagged a clearance from the FDA for a surgical stapler system designed for its single-port robotic platform, in what it describes as an agency first. The company’s SP SureForm 45 was greenlighted for use with its da Vinci SP system, spanning minimally invasive thoracic, colorectal and urologic procedures. Compared to its other robotic surgery systems—for example, the latest da Vinci 5, with its multiple arms that may operate through more than one opening in the body—the da Vinci SP can deliver three instruments, such as forceps and cutters, plus a 3D camera all through a single incision.The SP SureForm 45 is built off the same technology as its multiport counterpart, including systems to monitor tissue compression before and during stapling to ensure a secure hold and reduce the risk of damage.“Being able to use a SureForm 45 stapler in single-port robotic surgery helps provide surgeons with more control of their procedures from the da Vinci surgeon console, without the need to rely on an assistant to fire a stapler,” Intuitive Chief Medical Officer Myriam Curet, M.D., said in a statement. “This kind of control can help save valuable operating time.”While the da Vinci SP system is also cleared in the U.S. for transoral procedures for the mouth and throat, the SureForm 45 stapler instrument was not.  Late last month, Intuitive also put forward two preclinical studies of the force feedback capabilities included with its da Vinci 5 robot, with its full-scale commercial launch set for this year. According to the company, the experiments found that force feedback at the surgeon’s control console led to gentler surgeries—with reductions in the total force applied to tissue models, during practice procedures of retraction, dissection and suturing.“The lack of a way to measure the forces applied to tissue may result in excessive force exerted, leading to unintentional tissue damage during surgery, which could have a negative clinical impact on patients including pain and recovery time,” said Michael Awad, M.D., Ph.D., a professor of surgery at Washington University School of Medicine in St. Louis, who helped conduct one of the studies published in the journal Surgical Endoscopy. That paper saw reductions in force by as much as 43% regardless of the surgeon’s experience level. The second study, performed at Cedars-Sinai Medical Center in Los Angeles, showed that novice surgeons saw less tissue trauma and fewer errors during suturing. “Suturing can be a unique challenge during robotic surgery because excessive force can break delicate sutures or injure healthy tissue, while insufficient forces might cause slippage or loose sutures,” said Andrew Hung, M.D., an associate professor of urology and computational biomedicine at Cedars-Sinai.