| EMDDB code |
22028
|
| Basic UDI-DI |
JVNPIVLFZ3
|
| Seadme klass |
Protseduuripakett
|
| Medical Device Nomenclature |
|
| Risk class |
IIb
|
| Appliance |
-
|
| Device name (in Estonian) |
Perifeerse intravaskulaarse litotripsia (IVL) kateeter Shockwave Javelin
|
| Device name (in English) |
Shockwave Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter
|
| Intended use (is Estonian) |
Shockwave'i perifeerse intravaskulaarse litotripsia süsteemi kavandatud kasutus on stenootiliste arterite laiendamine sihtarteris oleva naastu modifitseerimise kaudu, kasutades seadme veresoone seina modifitseerivaid omadusi. Intravaskulaarse litotripsia protseduuri kaltsiumi modifitseerimise aspekt tähendab stenoosi eeltöötlust, modifitseerides kaltsifitseerunud naastu struktuuri ja kuju, et võimaldada veresoone laiendamist kateetriga ning perifeerse intravaskulaarse litotripsia kateetri Javelin edasiviimist
|
| Intended use (in English) |
The intended use of the Shockwave Peripheral Intravascular Lithotripsy System is to dilate stenotic arteries by modifying the plaque present in the target artery using vessel wall modifying attributes of the device. The calcium modification aspect of the procedure using intravascular lithotripsy is a preconditioning of the stenosis by modifying the structure and compliance of the calcified plaque, enabling catheter dilatation of the vessel and further advancement of the Javelin Peripheral IVL Catheter.
|
| Type/model/article number |
JVNPIVLF
|
| Manufacturer |
Shockwave Medical Inc.
|
| Authorised representative |
ICON (LR) Limited
|
| In register from |
05/20/2025
|
| Entry status |
Active
|
| Reimbursed by EHIF |
Tervisekassa soodustus puudub
|
