Embocept S DSM 50 um

Primary DI

07350108050012

Basic UDI-DI Code

B-07350108050012

Reference

493094

Device Types

Single use Reprocessed Sterile Sterilization

Regulation

Eu Mdd

Classification

Eu Md Class 2b

Status

On The Market

Manufacturer

Magle Chemoswed AB

EmboCept® S DSM 50 μm is a suspension of degradable starch microspheres (DSM) for injection intended as adjuvant for the intra-arterial therapy of liver and lung tumours in combination with cytostatic agents. These microspheres are produced from partially hydrolysed starch. EmboCept® S DSM 50 μm particles have a size of 20 to 90 μm, 95% of the particles are within this size range and have a mean diameter of 50+7 μm. They are degraded by serum alpha-amylase, but due to a higher degree of crosslinking at the periphery, DSMs maintain their size until they finally degraded and disappear. The total time of occlusion is therefore indirectly proportionate to the amount of alpha-amylase present in the plasma. The half-life in vitro at 37 °C is approximately 30-40 minutes. Thus, these microspheres induce a short-lasting temporary vascular occlusion, in contrast to non-degradable particles that induce permanent chemoembolisation. Consequently, treatment sessions using DSM- induced vascular occlusion and can be repeated. EmboCept® S DSM 50 μm occludes liver and lung vessels to induce by ischaemia and by optimisation of the intra- tumoural drug accumulation tumour necrosis.

Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).