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: Nit-Occlud® PDA
PMA Applicant: pfm medical ag
Address: Wankelstr. 60, Cologne, 50996, Germany
Approval Date: August 16, 2013
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf12/P120009a.pdf
What is it? The Nit-Occlud® PDA is a device that functions as a “plug” (occluder) to close an abnormal opening between the pulmonary artery and the aorta . This congenital heart defect (abnormality) is called a “PDA.” The occluder is made of a self-expanding coil spiral which consists of an inner (core) wire tightly wrapped by an outer coil wire. After the device is in place, tissue will grow over it and the device then becomes part of the pulmonary artery.
How does it work? A delivery tube (catheter) containing the occluder is threaded into a vein in the groin and through the pulmonary artery. It is then advanced through the defect. When it is in the correct position, the coil is advanced through the catheter into the aorta. The coil wire is then released so that the last loop is on the pulmonary side of the defect.
When is it used? The Nit-Occlud® PDA is a device implanted by a catheter-based procedure and intended for the non-surgical closure of a PDA.
What will it accomplish? This device can prevent blood from passing through the PDA which may cause symptoms such as fatigue, difficult or rapid breathing, failure to grow normally, or chronic respiratory infections such as colds and pneumonia. Large openings can lead to heart failure and death. The device is implanted without the use of open-heart surgery.
When should it not be used? The Nit-Occlud® PDA should not be used in patients with:
- Blood clots present at the site of the defect or blood clots in the vessels leading to the defect.
- Active inflammation of the heart (endocarditis)
- Body weight less than 11 pounds
- High blood pressure in the pulmonary artery and smaller arteries in the lungs
Additional information: The Summary of Safety and Effectiveness Data and labeling are available.