Telix's Illuccix Receives Approvals in Europe and Denmark for Prostate Cancer Imaging
• Telix Pharmaceuticals' Illuccix receives European marketing authorization for prostate cancer imaging, following a positive decision via decentralized procedure.
• Illuccix is now approved in Denmark for detecting PSMA-positive lesions in adults with prostate cancer across multiple clinical settings.
• PSMA-PET imaging with Illuccix offers superior accuracy for staging primary disease and evaluating biochemical recurrence, replacing conventional methods.
• The approvals set the stage for commercial launches in Europe and Denmark, enhancing access to advanced prostate cancer diagnostics.
AngioDynamics' NanoKnife System Receives FDA Clearance for Prostate Tissue Ablation
• AngioDynamics has received FDA clearance for its NanoKnife System for prostate tissue ablation, marking a significant advancement in minimally invasive cancer treatment.
• The PRESERVE clinical study demonstrated that 84% of men were free from clinically significant prostate cancer 12 months post-procedure using the NanoKnife System.
• The study also showed strong quality of life outcomes, with urinary continence preserved in 95.4% of patients and minimal impact on erectile function.
• The NanoKnife System offers a non-thermal, radiation-free alternative to traditional treatments, potentially reducing complications and improving patient quality of life.
FDA Approves R3 Vascular's IDE for ELITE-BTK Trial of Magnitude Scaffold in PAD
• R3 Vascular received FDA IDE approval to begin the ELITE-BTK pivotal trial, evaluating the Magnitude drug-eluting bioresorbable scaffold for below-the-knee PAD.
• The Magnitude scaffold, made from a unique polylactic acid polymer and coated with sirolimus, aims to improve outcomes in chronic limb-threatening ischemia (CLTI) patients.
• The ELITE-BTK trial will enroll 264 subjects across 60 global sites, with the goal of securing premarket approval (PMA) for the Magnitude device.
• Magnitude demonstrated promising early results in a first-in-human study with 96% patency at six months, suggesting potential to transform peripheral interventions.
AngioDynamics Launches Long-Term Study of NanoKnife for Prostate Cancer Treatment
• AngioDynamics and UCLH have initiated a prospective registry study to assess the long-term efficacy and safety of the NanoKnife system in treating intermediate-risk prostate cancer.
• The NanoKnife system utilizes irreversible electroporation (IRE) to induce controlled cell death in tumors while minimizing damage to surrounding healthy tissues.
• The study aims to enroll 500 patients globally, tracking outcomes to validate NanoKnife's effectiveness in reducing the need for radical interventions and preserving patient quality of life.
• UCLH, the first UK NHS facility to use NanoKnife, will leverage the registry to refine treatment protocols and standardize patient selection for improved outcomes.
AngioDynamics Launches RECOVER-AV Trial for AlphaVac System in Pulmonary Embolism Treatment
• AngioDynamics has initiated the RECOVER-AV trial to assess the AlphaVac F1885 System's safety and efficacy in treating acute, intermediate-risk pulmonary embolism (PE).
• The multi-center, multi-national trial will enroll patients across Europe, evaluating the reduction in right ventricular/left ventricular (RV/LV) ratio post-procedure.
• The study follows the APEX-AV trial in the U.S., which demonstrated the AlphaVac system's safety and effectiveness in improving right ventricular function and reducing clot burden.
• The AlphaVac F1885 System received CE Mark approval in Europe, allowing AngioDynamics to expand its reach in treating PE, where prevalence is higher than in the U.S.
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