BioMime ™ 4O

Primary DI

18904224923505

Basic UDI-DI Code

B-18904224923505

Reference

BIF30032

Device Types

Single use Sterile

Regulation

Eu Mdd

Classification

Eu Md Class 3

Status

On The Market

Manufacturer

Meril Life Sciences Pvt. Ltd.

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.

Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).