Valve Specs

Question 1

28 mm valve Annulus Diameter

Answer 1

24 - 27 mm

Question 2

31 mm valve Annulus Diameter

Answer 2

27 - 30 mm

Question 3

34 mm valve Annulus Diameter

Answer 3

30 - 33 mm

Question 4

22 mm Annulus Perimeter

Answer 4

57 - 66 mm

Question 5

25 mm valve Annulus Perimeter

Answer 5

66 - 75 mm

Question 6

28 mm valve Annulus Perimeter

Answer 6

75 - 85 mm

Question 7

31 mm valve Annulus Perimeter

Answer 7

85 - 94 mm

Question 8

34 mm valve Annulus Perimeter

Answer 8

94 - 104 mm

Question 9

22 mm valve Annulus Area

Answer 9

254 - 346 mm

Question 10

25 mm valve Annulus Area

Answer 10

346 - 452 mm

Question 11

28 mm valve Annulus Area

Answer 11

452 - 573 mm

Question 12

31 mm valve Annulus Area

Answer 12

573 - 707 mm

Question 13

34 mm valve Annulus Area

Answer 13

707 - 855 mm

Question 14

22 mm Annulus Diameter

Answer 14

18 - 21 mm

Question 15

25 mm Annulus Diameter

Answer 15

21 - 24 mm

Question 16

Name the four load assists and organizers (18 Fr & 21 Fr)

Answer 16

Distal Funnel
Proximal Funnel
Anchor Ring Funnel
Organizer

Question 17

Name the knobs of the delivery device handle

Answer 17

Clear Steering Knob
Two Control Knobs (Yellow Anchor Ring Knob)(gray Nosecone/Valve Knob)

Question 18

What does the clear steering knob do?

Answer 18

Controls catheter deflection

Question 19

What does the yellow anchor ring knob do?

Answer 19

Slides along the handle to control the placement of the Anchor Ring. Once the safety mechanism is unlocked it rotates to deploy/release valve

Question 20

What does the gray nosecone/valve knob do?

Answer 20

Slides to position valve frame within the anchor ring. Once safety mechanism is unlocked it rotates to deploy valve.

Question 21

Patients must be able to tolerate anti coagulation/anti platelet regimen. T or F

Answer 21

True

Question 22

Severe calcification is acceptable in patient anatomy. T or F

Answer 22

False

Question 23

Congenital aortic stenosis or unicuspid or bicuspid aortic valves are a contraindication. T or F

Answer 23

True

Question 24

When inspecting the Steering knob how many rotations should be done to observe catheter deflection.

Answer 24

Three

Question 25

When inspecting the nosecone and anchor ring knobs it is okay to rotate them past 90 degrees while inspecting. T or F

Answer 25

False - do not rotate past 90 degrees as this can fully retract prematurely.

Question 26

It is okay to remove the delivery device from the tray completely in order to load the valve. T or F

Answer 26

False - leave delivery device snapped into device tray during valve loading.

Question 27

What are the five key inclusions in the CIP?

Answer 27

1. Patient has symptomatic (NYHA FC > or = to IIs) severe (> or = 3+) native AR diagnosed by echo
2. Patient is judged by a multi-disciplinary heart team to be at high risk for surgery.
3. Patient has suitable anatomy for J-Valve implantation.
4. Patient or the patient’s legal representatives has provided written informed consent.
5. Patients or patient’s legal representative agrees to comply with all required post-procedure follow-up visits.

Question 28

22 mm Valve Height?

Answer 28

17 mm

Question 29

25 mm Valve Height?

Answer 29

19 mm

Question 30

28 mm Valve Height?

Answer 30

22 mm

Question 31

34 mm Valve Height?

Answer 31

25 mm