| Device |
drug-eluting percutaneous transluminal coronary angioplasty catheter |
| Definition |
A drug-eluting percutaneous transluminal coronary angioplasty catheter is a combination product intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A drug-eluting ptca catheter may also be intended for the treatment of acute myocardial infarction; Treatment of in-stent restenosis (isr) and/or post-deployment stent expansion. A drug-eluting ptca catheter delivers a drug to the vessel as part of the angioplasty procedure, which is intended to inhibit restenosis. |
| Physical State |
The balloon catheter is generally constructed of synthetic materials such as plastic and introduced into the body using a guidewire. The balloon is generally manufactured in multiple diameters and lengths to allow for treatment of different lesion sizes. |
| Technical Method |
The balloon catheter uses mechanical force across a lesion to establish patency. The drug coating serves as an adjunct to the mechanical action of balloon angioplasty and assists in maintaining vessel patency post-procedure. |
| Target Area |
Hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia |
| Review Panel |
Cardiovascular |
|---|
| Product Code | OOB |
|---|
| Premarket Review |
Coronary and Peripheral Interventional Devices
(DHT2C)
Coronary and Peripheral Interventional Devices
(DHT2C)
|
| Submission Type |
PMA
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
