Guerbet Secures EU Regulatory Milestone for Lipiodol® in Vascular Embolization

Guerbet, a prominent name in medical imaging, has achieved a significant regulatory milestone with the approval of a new indication for Lipiodol® Ultra Fluid. This progress was marked by a successful worksharing procedure involving several EU member states, which paves the way for national approvals in the use of Lipiodol® for peripheral and central vascular embolization procedures.

The newly approved indication allows for the combination of Lipiodol® with cyanoacrylate-based surgical glues, enhancing the visualization and control during endovascular procedures. This regulatory step is poised to significantly influence interventional radiology protocols, emphasizing the clinical applicability of Lipiodol® in minimally invasive treatments.

Once national approvals are secured, healthcare professionals will benefit from integrating Lipiodol® in embolization procedures, supported by clear instructional guidelines. The product's characteristics—radiopacity, controlled viscosity, and compatibility with a range of cyanoacrylate glues—are expected to offer enhanced procedural control.

Vascular embolization is recognized in Europe as a minimally invasive and effective technique in various medical guidelines. The new indication enables the use of Lipiodol® in procedures such as prostate artery embolization for benign prostatic hyperplasia, management of varicoceles or varices, and treatment of certain hemorrhages and vascular abnormalities. The data submitted in support of this indication highlighted the low risk of significant complications, real-time imaging capabilities, and adaptability to different anatomical and clinical circumstances.

Francois Convenant, Senior Vice President of Interventional Radiology at Guerbet, emphasized the significance of this development, stating, "This regulatory achievement for Lipiodol® in vascular embolization marks a considerable milestone for our field. It formalizes years of clinical practice and harmonizes glue embolization techniques across Europe."

The advancements in interventional radiology demand embolic agents that provide precision and adaptability. Lipiodol®’s ability to be combined with cyanoacrylate-based glues offers clinicians a controllable and highly radiopaque embolic agent. This allows for immediate vessel occlusion visualization, adjustable viscosity, and polymerization time, ultimately achieving effective and durable vessel occlusion with reduced need for repeat procedures.

Guerbet reaffirms its commitment to supporting interventional radiology teams by providing extensive scientific and clinical support, dedicated educational programs, and reliable solutions aimed at enhancing patient care and safety in a cost-efficient manner.