It's here. Bard Medical has finally received FDA clearance to release The Flair Endovascular covered stent graft for management of dialysis access. The device, which comes in a flared configuration as well as a tube configuration has demonstrated impressive results in randomized prospective trial compared to percutaneous angioplasty.
The approval comes after a long period of anticipation. For information regarding FDA approval and indications for the Flair Endovascular Stent Graft.
It will be interested to see how the device, indicated for graft to vein stenosis changes the pattern of treatment in various dialysis access settings like the hospital, ambulatory surgical facility and the extension of practice access maintenance center.
In my mind, the device should be reserved for graft to vein stenosis that have failed angioplasty as evidenced by early recurrence. I dont think it should be used in lieu of PTA. My rationale is based on the palliative rationale of access management and I think that immediate placement of a covered stent shortens the course of available catheter based options.
I don't suspect that the Flair will be used as a primary therapy. Even the Bard reps sell the idea that if the lesion demonstrates elastic recoil after PTA, particularly ultra-high pressure PTA), then the stent-graft should be used to revise the anastomosis and open up the stenosis.
Posted by: Garry | November 04, 2008 at 07:55 PM
I agree that in the ideal world, the Flair should be reserved for "true" PTA failure. My concern is that in some settings where previously, proceduralist have demonstrated a lowered threshold for stent placement; those same physicians will now have a low threshold for Flair placement because of the additional facility reimbursement for the Extension of Practice model
Posted by: lee | November 05, 2008 at 10:39 AM