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: Cheatham Platinum (CP) Stent System (Covered CP Stent and Covered Mounted CP Stent)
PMA Applicant: NuMED, Inc.
Address: 2880 Main Street, Hopkinton, New York 12965
Approval Date: October 24, 2017
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150028S001a.pdf
What is it? The Covered CP Stent is a metal framework covered with cloth to patch a blood vessel tear in patients born with heart defects. This device was approved previously to reopen a blocked or narrowed aorta. The stents are placed using a balloon in balloon (BiB) catheter (a long tube).
How does it work? The stent is compressed and placed on the end of the BiB catheter. The catheter is inserted through the skin in the upper leg (groin) and pushed through the blood vessels until it reaches the target location. The stent is then expanded with the balloon. Once the stent is in place, the balloon catheter is removed from the body.
When is it used? Patients born with heart defects often receive a pulmonary valve conduit (a tube with a valve inside), also known as a right ventricular outflow tract (RVOT) conduit. The RVOT conduit is used to correct the defects. Over time, the conduit may become narrowed or leaky and will need to be replaced. If a patient who has previously had a conduit implanted needs a new pulmonic valve one option for replacement is the use of a transcatheter heart valve (THV). As part of the procedure to replace the pulmonic valve a BiB catheter is used to widen the area where the new valve will be located. Sometimes, this process causes the RVOT conduit to rupture or tear. The Covered CP Stent is used to cover the tear in the conduit before implanting a THV.
What will it accomplish? If the Covered CP stent is able to successfully close the tear in the RVOT conduit, the surgeon may be able to continue implanting the new THV. If this approach is possible, the new valve can be implanted without open heart surgery. In a clinical study of 50 patients, about 9 out of 10 had successful closure of the conduit tear with use of the Covered CP Stent followed by successful implantation of a pulmonic valve.
When should it not be used? The Covered CP Stents should not be used in patients who:
- are too small to allow safe delivery of the stent without injury to a systemic vein or to the right side of the heart
- exhibit clinical or biological signs of infection
- have active infection in the heart (endocarditis)
- are pregnant
Additional information (including warnings, precautions and adverse events): Summary of Safety and Effectiveness and labeling are available online.