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U.S. Department of Health and Human Services

Medical Devices

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Formula Balloon-Expandable Renal Stent System - P100028

Picture of the device.

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Formula Balloon-Expandable Renal Stent System
PMA Applicant:
Cook, Inc.
Address:
750 Daniels Way, P.O. Box 489, Bloomington, IN 47402-0489
Approval Date:
January 14, 2010
Approval Letter:
http://www.accessdata.fda.gov/cdrh_docs/pdf10/p100028a.pdf

What is it? The Cook Formula Balloon-Expandable Renal Stent System 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.

How does it work? The Formula Balloon-Expandable Renal Stent System is inserted following balloon angioplasty (a less invasive procedure than surgery during which the artery is opened or expanded using a balloon). The stent is threaded up to the renal artery through a catheter and inserted in either the groin or the arm.

  • A wire is inserted into the vessel in the arm or groin and advanced to the blood vessel leading to the kidney where there is blockage.
  • The Formula stent on the delivery catheter is advanced over the wire to the blocked area.
  • The stent is then released from the delivery catheter and opens over the blockage by inflating a balloon that is underneath the stent on the delivery device.

The delivery catheter and balloon are removed, followed by the guide wire.

When is it 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.

What will it accomplish? The stent is supposed to open blockages in the blood vessel in patients previously treated with an unsuccessful balloon angioplasty procedure. In a clinical study involving 100 patients, the rate of reblocking (restenosis) of the artery at 9 months was less in the study patients than the rate of restenosis reported in the literature for angioplasty alone. Results also showed that kidney function and high blood pressure had not significantly worsened at nine months.

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.

Additional information : Summary of Safety and Effectiveness and labeling will be available online.