Life Vascular Devices Biotech, S.L.

Life Vascular Devices Biotech, S.L. specializes in peripheral angioplasty balloon catheters. These devices are primarily used to treat narrowed, blocked, or damaged blood vessels caused by stenotic, restenotic, or occlusive lesions, as well as endovascular injuries and ischemic stroke cases. The company’s product line includes variants like the iVascular oceanus series, which are designed for targeted vascular interventions.

The company is headquartered in Spain, as indicated by its legal registration. This location influences its regulatory compliance, particularly under EU medical device regulations, which govern its product classifications and market authorization processes.

The devices produced by Life Vascular Devices Biotech, S.L. are registered in the eudamed database, which is the official EU registry for medical devices. This registration ensures transparency and compliance with EU regulatory requirements for Class IIa and Class III devices.

The company’s peripheral angioplasty balloon catheters are classified as Class III or Class IIa under EU medical device regulations. This classification is determined by factors such as the device’s risk level, intended use, and potential impact on patient safety. Class III devices typically involve higher-risk procedures, such as treating ischemic stroke or critical vascular blockages, while Class IIa devices may pose moderate risks.