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: Express® SD Renal Monorail® Premounted Stent System
PMA Applicant: Boston Scientific Corporation
Address: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760
Approval Date: December 11, 2008
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf6/P060006a.pdf
What is it? The Express® SD Renal Monorail® Premounted Stent System is used to re-open stenotic (narrowed) regions of the renal arteries which supply blood to the kidneys, and 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 the delivery catheter: a long, thin, tube-like device.
How does it work? The Express® SD Renal Monorail® Premounted Stent System is inserted following balloon angioplasty (a less invasive procedure than surgery during which the artery is opened or expanded using a balloon), during which the stent is threaded up to the renal artery via a catheter 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 Express® SD 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 guiding wire.
When is it used? The Express® SD Renal Monorail® Premounted Stent System is used in patients with reduction of blood flow to the arteries leading to the kidneys as an adjunct to 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 a balloon angioplasty. 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 with uncorrected bleeding disorders or patients who cannot receive blood thinners
- Persons with known allergies to stainless steel or its components
- A lesion that is within or next to an aneurysm (bulging and weakened blood vessel)
- Patients with a target lesion next to an area with a large amount of blood clotting
- Patients who have problems preventing the catheter from getting to the blockage
- Patients with perforated vessels as evidenced by leakage of contrast media
- Patients with a lesion that cannot be crossed with a wire and/or a balloon catheter
Additional information: The Summary of Safety and Effectiveness and Labeling is available online.