RX Herculink Elite Renal Stent System - P110001
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: RX Herculink Elite Renal Stent System
PMA Applicant: Abbott Vascular
Address: 26531 Ynez Road, Temecula, CA 92591
Approval Date: July 20, 2011
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf11/p110001a.pdf
What is it? The RX Herculink Elite 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 cobalt chromium, 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 RX Herculink Elite 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 RX Herculink Elite Renal 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 RX Herculink Elite 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 202 patients, the rate of reblocking (restenosis) of the artery at 9 months was less in this study than the rate of restenosis reported in previous studies of renal artery stenting. 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 medicines that prevent blood clots or slow the development of blood clots.
- Patients with a known hypersensitivity to cobalt or chrome.
- 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.
- Patients with a blockage with a large amount of nearby short-lasting or close to short-lasting blood clots.
- Stenting of an arterial blood vessel where leakage from the artery could worsen by placement of a stent.
Additional information: Summary of Safety and Effectiveness and labeling are available online.