BioMime ™ 4O

Trade name

BioMime ™ 4O

18904224923925

B-18904224923925

Reference / catalog number

BIF30025030

GS1

Class III

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The Sirolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in the following: -Patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. -For restoring coronary flow in patients experiencing acute myocardial infarction who present within 12 hours of symptom onset. -For the treatment of patients with concomitant diabetes, acute coronary syndrome,dual vessel lesions (two lesions in two different epicardial vessels), lesions residing within small coronary vessels; lesions where treatment results in the jailing of side branches (lesions with a side branch < 2 mm in diameter or an ostial stenosis < 50%); for the treatment of elderly patients (age ≥ 65), and for treatment of both men and women. -For the treatment of patients presenting with in-stent restenosis in coronary artery lesions; chronic total occluded coronary artery lesions (defined as coronary artery lesions with TIMI flow 0 and lasting longer than 3 months); and coronary artery bifurcation lesions. -In all cases ;-For Linear models the treated lesion length should be ≤ 44mm with reference vessel diameter of 2.00 mm to 4.50 mm. -For Tapered models the treated lesion length should be ≤ 56mm with reference vessel diameter of 2.25 mm to 3.50 mm.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 2.5–3 MU50
• 30 MU50

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

• P070402010301CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS

7 warnings recorded — scroll inside the panel to see all entries.

• CW011

  EUDAMED did not publish a description for this code.
• CW030

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• CW010

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• CW264

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• CW001

  EUDAMED did not publish a description for this code.