The Cook Formula Balloon-Expandable Renal Stent System has been approved by the Center for Devices and Radiological Health of the US Food and Drug Administration.
It is used to re-open narrowed (stenotic) regions of the renal arteries which supply blood to the kidneys. It consists of two components, the stent and the delivery system. The stent is an implant constructed of stainless steel tubing, laser-cut into a mesh shape. The stent is mounted onto a long, thin, tube-like device called the delivery catheter.
When should it be used?
The Formula Balloon-Expandable Renal Stent System is used in patients with reduced blood flow to the arteries leading to the kidneys after unsuccessful balloon angioplasty of a single, not previously treated or reblocked lesion in the opening of the renal artery.
When should it not be used?
The device should not be used in the following patient populations:
- Patients who cannot take drugs that prevent blood clots or slow the development of blood clots.
- Patients who have a blockage that cannot be crossed with a wire or a balloon device that expands the blockage.
- Patients who have blockages that cannot be expanded to permit passage of the stent.
- Patients with bleeding problems.
- Stenting of an arterial blood vessel where leakage from the artery could worsen by placement of a stent.
- Patients with a blockage with a large amount of nearby short-lasting or close to short-lasting blood clots.