||catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|
||To reduce coronary artery stenosis by dilatation of the balloon and by apposition of the cutting/scoring surfaces to the stenotic material for the treatment of coronary artery stenosis to improve myocardial perfusion.
||Cutting/scoring PTCA catheters are usually comprised of flexible polymers for the catheter body and a compliant polymer for the balloon. The cutting/scoring elements are usually metal.
||The device functions independently, but is typically placed using a guidewire and guiding catheter. The balloon is inflated by the infusion of liquid through the body of the catheter. Following treatment, the liquid is withdrawn, the balloon is deflated and then withdrawn from the body.
Office of Device Evaluation
Division of Cardiovascular Devices
Interventional Cardiology Devices Branch (ICDB)
|Total Product Life Cycle (TPLC)
TPLC Product Code Report
|Third Party Review
||Not Third Party Eligible