| Title |
Abbott GRAFTMASTER® RX Coronary Stent Graft System, humanitarian use device |
| Description |
The FDA has approved the Abbott GRAFTMASTER® RX Coronary Stent Graft System for commercial use in selected patients under a Humanitarian Device Exemption (HDE). Specifically, the stent has been approved for use in the treatment of perforations (tears) in a vessel wall (a native vessel or vein bypass graft) that can cause blood to leak into the lining of the heart. |
| HDE Number |
H000001 |
| Notes |
Percutaneous Coronary Interventions such as angioplasty, stent, or athrectomy procedures are treatments used to restore normal blood flow in coronary arteries and/or bypass grafts. Treatment with the GraftMaster Stent System may be a lifesaving measure to seal a perforated (torn) coronary artery. Additional information can be found at FDA.gov/medicaldevices |
| Start Date |
01/01/2016 |
| Principal Name |
Steven Writer, MD |
| Contact Name |
Mark Parent, MD; Alex Johnson, MD; Peter Roan, MD; Carl Kapadia, MD; Steven Fonken, MD |
| Phone |
(208) 367-7397 |
