Approval for the endovascular treatment of patients with type b aortic dissection. The zenith tx2 dissection endovascular graft with pro-form is intended to seal the entry tear(s) and to exclude aneurysms associated with chronic dissections. The zenith dissection endovascular stent is intended to be used as a distal component to provide support to delaminated segments of non-aneurysmal aorta with dissection distal to a zenith tx2 dissection endovascular graft with pro-form. The system is indicated for use in patients having suitable vascular anatomy for endovascular repair, including: adequate iliac/femoral access compatible with the required introduction systems; for the zenith tx2 dissection endovascular graft with pro-form: non-dissected/aneurysmal aortic segments (fixation sites) distal to the left common carotid artery and proximal to the entry tear with a length of at least 20 mm for the graft, and non-dissected/aneurysmal aortic segments (fixation sites) distal to the left common carotid artery and proximal to the entry tear with a diameter (measured outer-wall to outer-wall) of no greater than 38 mm and no less than 20 mm for the graft; for the zenith dissection endovascular stent: diameter at non-aneurysmal intended implant site for the stent (measured outer-wall to outer- wall) of no greater than 38 mm (true lumen) and no less than 20 mm (total aortic diameter).
| Device | Zenith Dissection Endovascular System |
| Classification Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | WILLIAM COOK EUROPE APS |
| Date Received | 2018-01-02 |
| Decision Date | 2018-12-31 |
| Notice Date | 2019-01-25 |
| PMA | P180001 |
| Supplement | S |
| Product Code | MIH |
| Docket Number | 19M-0028 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | WILLIAM COOK EUROPE APS sandet 6, Dk-4632 bjaeverskov |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P180001 | Original Filing | |
| S006 | 2022-06-06 | Real-time Process |
| S005 | 2022-05-05 | Special (immediate Track) |
| S004 | 2022-03-18 | Special (immediate Track) |
| S003 | 2021-11-15 | 30-day Notice |
| S002 | 2020-10-02 | Normal 180 Day Track No User Fee |
| S001 | 2019-10-01 | Normal 180 Day Track No User Fee |