Device Dossier
VessCrack Coronary IVL Balloon Dilatation Catheter - Intravascular lithotripsy system balloon catheter, coronary
Device Dossier for VessCrack Coronary IVL Balloon Dilatation Catheter - Intravascular lithotripsy system balloon catheter, coronary (Intravascular…
- GMDN category: Intravascular lithotripsy system balloon catheter, coronary
Intended purpose
The product is used in medical institutions, in combination with the Intravascular Lithotripsy Generator (Model: LP-AW-200A) manufactured by Lepu, for preconditioning and balloon dilation of primary coronary artery calcified lesions (coronary artery stenosis greater than or equal to 50 percent) in adult patients before stent implantation.
Functional description
Catheter includes soft tapered tip and balloon to facilitate low resistance and smooth navigation through complex and tortuous vascular pathways with minimizing vessel trauma. Two radiopaque platinum marker bands with balloon provide visibility under fluoroscopy to accurately position catheter and balloon. Quadruple-lumen distal tube: two release acoustic wave to disrupt calcium within lesion, one guidewire lumen to navigate catheter, one filling lumen to fill balloon with contrast mixture.