Embocept S DSM 50 um

Organization name

Magle Chemoswed AB

SRN

SE-MF-000003569

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  Pains in the region of the target organ caused by vessel occlusion (usually subsides after about 30 – 60 minutes and disappears after approximately 1 hour. Ischemic pain (epigastric discomfort, chest pains) Transient functional impairment in the target organ (e.g. elevated liver enzymes) Dyspnoea Caused by the combination with cytostatic drugs: nausea, vomiting, diarrhoea, mucosal inflammation, fever, shivers, cough, ulcers in the upper gastrointestinal tract (not possible to attribute directly to the embolisation)

Primary placement in Germany; available across 14 countries total.

Trade name

Embocept S DSM 50 um

UDI-DI code

07350108050012

Basic UDI-DI

B-07350108050012

Reference / catalog number

493094

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 50 MU128

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• C010402020303EMBOLISATION PARTICLES AND MICROSPHERES