Edwards SAPIEN 3 User Manual Manual

User Manual Manual for Edwards SAPIEN 3 Medical Equipment (46 pages)

Specifications:

804/804514-sapien_3.pdf file (18 Dec 2023)
  • Manufacturer: Edwards
  • Category of Device: Medical Equipment
  • Document: SAPIEN 3, File Type: PDF User Manual Manual
  • Updated: 18-12-2023
  • Count of Pages: 46
Download SAPIEN 3 Manual (46 pages)

Read PDF Document Online:

Data: UPD 18th December 2023

Edwards SAPIEN 3 Medical Equipment PDF User Manual Manual (Updated: Monday 18th of December 2023 03:54:07 AM)

Rating: 4.5 (rated by 63 users)

Compatible devices: Bure Double 2.0 56-303, CP101, Vigilance II, EH500, EV1000, Dialysis 6.5330.100, EV1000A, ES Series.

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Text Version of Edwards SAPIEN 3 Medical Equipment Manual (Summary of Contents)

(Ocr-Read of Edwards SAPIEN 3 Document (Main Content), UPD: 18 December 2023)

  • 38, 38 In the PIIA-SAVR EP population, the mean duration in the operating room was 333.2 ± 96.4 min, the mean total procedure time was 237.5 ± 86.58 min, and the mean anesthesia time was 333.5 ± 108.42 min. General anesthesia was used in all patients. Valve Performance The …

  • 2, Edwards SAPIEN 3 2 1.0 Device Description • Edwards SAPIEN 3 Transcatheter Heart Valve- Model 9600TFX (Figure 1) The Edwards SAPIEN 3 Transcatheter Heart Valve is comprised of a balloon-expandable, radiopaque, cobalt-chromium frame, trileaflet bovine pericardial tissue valve, and polyethylene …

  • 25, 25 Table 15: CEC Adjudicated Adverse Events at 1 Year (S3OUS AT Population) 30 Day 1 Year Outcomes SAPIEN 3 Valve Overall SAPIEN 3 Valve Transfemoral Access SAPIEN 3 Valve Non- Transfemoral Access SAPIEN 3 Valve Overall SAPIEN 3 Valve Transfemoral …

  • 5, 5 o Blood dyscrasias defined as: leukopenia (WBC < 3000 cells/mL), acute anemia (Hb < 9 g/dL), thrombocytopenia (platelet count < 50,000 cells/mL), or history of bleeding diathesis or coagulopathy o Hypertrophic cardiomyopathy with or without obstruction (HOCM) o Echocar…

  • 4, 4 mishandled or damaged during any part of the procedure will require replacement of the valve. • Caution should be exercised in implanting a valve in patients with clinically significant coronary artery disease. • Patients with pre-existing mitral valve devices should be …

  • 23, 23 Accountability of the S3OUS Cohort Patients were treated at 14 investigational sites. Note that the intermediate risk patients enrolled in the S3OUS study were excluded from the analysis presented herein. The database included 102 “all treated” (AT) inoperable and high surgical…

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