WRAPSODY

Question 1

SCV = ?

Answer 1

Sublavian Vein

Question 2

IJ-Vene = ?

Answer 2

interjugular vein

Question 3

ESRD = ?

Answer 3

End stage renal disease

Question 4

ESRD population in the U.S., prevalence and incidence

Answer 4

600k + 100k new patients every year

Question 5

ESRD population in Germany, prevalence and incidence

Answer 5

80k + 13k new patients every year

Question 6

3-year mortality CVC (Central Venous Catheter), AV graft, AV fistula

Answer 6

80%, 30%, 20%

Question 7

WRAPSODY - what catheter lengths?

Answer 7

120cm and 80cm

Question 8

Why is it important to use a stiff guidewire?

Answer 8

Allows the Wrapsody catheter to be tracked through tortuous anatomy.

Question 9

WRAPSODY indications

Answer 9

EU Indication: The Merit WRAPSODY™ Endovascular Stent Graft System is a flexible, self-expanding prosthesis for endovascular treatment of stenosis, occlusions, or dissections in the peripheral vein.

US Indication: The Merit WRAPSODY Endovascular Stent Graft System is intended for use in patients with an arteriovenous (AV) fistula or AV graft for the treatment of venous outflow stenosis or occlusion located in the arm or central veins*
s* and arteries.

Question 10

Can Wrapsody be used to treat aneurysms?

Answer 10

The device is not indicated for aneurysms use. However, it is at the discretion of the physician what is in the best for the patient.
Merit has not tested Wrapsody for use in aneurysms.
The end rows on the stent have reduced radial force.

Question 11

What are the competitive self expanding stent graft products?

Answer 11

Gore Viabahn.

Bard Fluency, Flair and Covera.

Question 12

What are the competitive advantages of each?

Answer 12

Gore Viabahn.
Long history of clinical data, heparin story.

Bard Fluency, Flair, Covera,
Long history of clinical data.
Covera- new deployment system and improved flexibility.
Flared ends

Question 13

What are the disadvantages of each?

Answer 13

Gore Viahbahn.
Some doctors report rapid restenosis of device.
Delivery system accuracy using a ripcord can be difficult, 2 handed.
Not indicated for Heparin sensitive patients.
No longitudinal compressive force.
No cell impermeable layer.
High variations in radial force across oversizing range= infolding.
Only scalloped on one end.

Bard Fluency, Flair, Covera.
Prone to kink.
Fluency=Uncovered flared ends which may cause edge stenosis.
2 handed deployment.
Covera- A Lifestent with a fluency covering.
Clinical Data pending.

Question 14

What are the competitive balloon expandable stent graft products?

Answer 14

Gore Viabahn VBX.
Bard Lifestream BX.
Atrium I-cast, V-12.

Question 15

What are the competitive advantages of balloon expandable stent graft products?

Answer 15

Gore Viabahn VBX.
High accuracy and adjustable diameter.
Low profile delivery

Bard LifeStream BX.
High accuracy and adjustable diameter.
Low profile delivery

Atrium I-cast, V-12.
High accuracy and adjustable diameter.
Low profile delivery

Question 16

What are the disadvantages of balloon expandable stent graft products?

Answer 16

Gore Viabahn, VBX
Reduced flexibility.

Bard Lifestream BX.
Reduced flexibility.

Atrium I-cast, V-12
May have changes in length based on target diameter.
Reduced flexibility.

Question 17

Are drug eluting balloons better than stent grafts?

Answer 17

Depends, each has a need. Many patient experience elastic recoil after PTA. Drug coated balloons do not treat elastic recoil and a stent is a preferred option.
Studies are not showing much clinical advantages (Lutonix IFU).
DCB reimbursement is questionable.

Question 18

What is the difference between a bare metal stent and a covered stent?

Answer 18

Covered stents have a better patency rates when compared to bare metal stents.
They also create a covering of the metal frame that has a favorable biologic response.

Question 19

I would rather use PTA

Answer 19

What about elastic recoil?
How many times are you willing to balloon the lesion?
What about the quality of life for the patient?
What about risks associated with multiple reinterventions?
What is the overall cost to the hospital and healthcare system with multiple PTA?