Contraindications - sorin Perceval S Gebrauchsanweisung

Additional equipment/materials required for prosthesis preparation and implantation
are:
- 1 sterile field for valve preparation
- 2 sterile bowls
- 2 bottles of sterile saline solution, one at room temperature, one at body tem-
perature (37°C)
- scissors
- 50 ml sterile Luer Lock syringe
- sterile indeflator (manometric syringe)
- atraumatic plastic forceps.
8. INDICATIONS
Perceval S prosthesis is indicated for the replacement of a diseased native or a
malfunctioning prosthetic aortic valve via open heart surgery.
The prosthesis is indicated in patients who meet the following criteria:
- Subjects of age ≥ 75 years;
- Subjects with aortic valve stenosis or steno-insufficiency.
9. CONTRA-INDICATIONS
Use of the Perceval S prosthesis is contra-indicated in the following cases:
1. Subjects with previous implantation of valve prostheses or annuloplasty ring
not being replaced by the Perceval S valve;
2. Subjects who require double or multiple valve replacement or repair;
3. Subjects with aneurysmal dilation or dissection of the ascending aortic wall;
4. Subjects with active endocarditis;
5. Subjects with active myocarditis;
6. Subjects with congenital bicuspid aortic valve;
7. Subjects with recent myocardial infarction (< 90 days);
8. Subjects with known hypersensitivity to nickel alloys;
9. Subjects with chronic renal impairment or calcium metabolism disorders;
10.Subjects receiving chronic drug treatment with preparation containing calcium;
11.The subject has had an acute preoperative neurological deficit, myocardial
infarction, or cardiac event that has not returned to baseline or stabilized 30
days prior to the planned valve implant surgery;
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