Minima Stent System – P240003
This is a brief overview of information related to the 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 the FDA’s approval.
Product Name: Minima Stent System Balloon Expandable Stent
PMA Applicant: Renata Medical
Address: 4675 MacArthur Ct, Suite 1150, Irvine, CA 92612
Approval Date: August 28, 2024
Approval Letter: Approval Order
What is it?
The Minima Stent System is an expandable metal (cobalt-chromium) mesh tube that can be used to reopen a narrowed pulmonary artery (blood vessel that carries blood from the heart to the lungs) or narrowed aorta (major artery carrying blood from the heart to the rest of the body).
A doctor inserts a balloon catheter (thin tube with a deflated balloon at the tip) with the compressed stent attached, into a vein or artery, usually within the groin. Using X-ray guidance, the doctor pushes it to the narrowed pulmonary artery or aorta. The balloon is inflated, expanding the stent, and widening the narrowed artery. After, the balloon is deflated, and the catheter is removed. The stent remains permanently implanted to act as a support for the newly opened blood vessel.
The Minima Stent System is used to reopen a blood vessel in neonates, infants, and children weighing at least 1.5 kg (3.3 lbs) who have:
- Coarctation of the aorta
- Pulmonary artery stenosis (narrowing of the large artery that delivers oxygen-rich blood to the heart)
In a clinical study following 42 patients for six months after the Minima Stent System was implanted, 41 of 42 patients were treated successfully. Successful treatment means that patients:
- Had their narrowed blood vessel widened to at least 75% the width of a nearby normal vessel.
- Did not have the implanted stent break.
The stent should not be used in patients who have:
- An active blood infection requiring antibiotics within seven days of the procedure.
- A history of or current endocarditis being treated with antibiotics within six months of the procedure.
- An aortic aneurysm or pulmonary artery aneurysm.
- A known allergy or hypersensitivity to aspirin or blood thinning medicine, and who cannot be treated with medicine that reduces blood clotting in an artery, vein, or the heart.
- A known allergy or hypersensitivity to stent materials (cobalt-chromium, which includes nickel) or contrast medium (a substance to show one part against surrounding tissue), who cannot be medicated beforehand at an acceptable level.