HomeCLINICAL TRIALS, STUDIES, REGISTRIES, DATA
CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
Ceryx Medical Initiates First-In-Human Study of the Cysoni™ RSA Pacemaker
Ceryx Medical notes the RSA-Pace study will enroll up to 60 patients at centers in the UK, New Zealand and Australia.
Anocca Announces Submission of Clinical Trial Application for Multi-asset Trial VIDAR-1 in Advanced Pancreatic Cancer
Hugh Salter, Chief Scientific Officer at Anocca, elaborated, "KRAS is an immensely important target in many cancer types, but has to date been challenging to address. KRAS mutations are a hallmark of PDAC, which is among the most difficult to treat cancers, and we believe TCR-T cell therapies and, in particular, our VIDAR-1 assets can be effective in addressing this target and providing a new solution in an indication with high unmet medical need.”
Enterprise Therapeutics Publishes on Medicinal Chemistry of ETD001 | A Novel Inhaled ENaC Blocker for Treatment of Cystic Fibrosis
The paper describes the medicinal chemistry optimisation of a new series of ENaC blockers, resulting in the invention of ETD001, Enterprise’s lead asset, a potential new inhaled treatment for cystic fibrosis notes Enterprise Therapeutics.
Elixir Medical Reports | LithiX HC-IVL System Data Demonstrate Sustained Safety and Efficacy at Six Months
“We developed LithiX to improve the IVL treatment of calcified lesions with shorter procedure times and effectiveness across a broad range of calcified lesions, and we’re delighted with the PINNACLE I study outcomes demonstrating its sustained safety and effectiveness,” said Motasim Sirhan, CEO of Elixir Medical. “Our team is committed to developing transformative cardiovascular technologies that deliver improved physician experiences and most importantly, better clinical outcomes for patients.”
SPYRAL HTN-ON MED Study Update | Shows significant, consistent, long-term blood pressure lowering effect at two years
"These findings are a key step toward informing the medical community of the long-term effectiveness with radiofrequency renal denervation as a treatment for uncontrolled hypertension," stated Dr. David Kandzari, Chief of Piedmont Heart Institute and Cardiovascular Services and lead principal investigator of the SPYRAL HTN-ON MED trial. "Importantly, at two years, we continue to see Symplicity is safe and consistent with clinically meaningful and significant blood pressure reductions. These data further substantiate sustained blood pressure reductions consistently observed in across the SPYRAL and Global Symplicity clinical programs."
Edwards Lifesciences | Groundbreaking Data Demonstrate Superiority of EARLY TAVR in Asymptomatic Severe Aortic Stenosis Patients
Trial investigators presented the data today during a late-breaking clinical trials session at Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation (CRF) and published simultaneously in The New England Journal of Medicine notes Edward Life Sciences.
Penumbra Announces Completion of THUNDER IDE Study Enrollment for Acute Ischemic Stroke
The THUNDER IDE study is a multi-center, single-arm study evaluating patients with acute ischemic stroke secondary to intracranial large vessel occlusion (LVO) who are eligible for mechanical thrombectomy. The primary efficacy endpoint includes revascularization of the occluded target vessel at immediate post-procedure.
Conformal Medical Announces Launch of the GLACE Study with Next-Gen CLAAS® AcuFORM™ Left Atrial Appendage Occlusion Device
"The use of ICE imaging in LAAO is growing significantly and will continue," said James Reinstein, President and CEO of Conformal Medical. "Our next-generation LAAO technology conforms to individual anatomies, enabling clinicians to simplify the procedure with 2 sizes, the ability to confirm seal, and eliminate general anesthesia & intubation."
Aethlon Medical Receives Ethics Committee Approval for Hemopurifier® Cancer Trial in India
"The approval from the MIEC, coming closely on the heels of our two ethics committee approvals in Australia, to conduct this early feasibility study, is another important step in our plan to evaluate use of the Hemopurifier as a treatment option in multiple tumor types, where cancer associated exosomes may promote immune suppression and metastasis," stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical.