FDA Approves Device to Prevent Scars in Children Following Open-Heart Surgery
The Food and Drug Administration has approved a medical device that reduces the risk of bands of scar tissue from forming in children following open-heart surgery.
Repel-CV, a synthetic film barrier made by SyntheMed, Inc. of Iselin, N.J., is placed over the heart following open-heart surgery to help reduce the severity of post-surgical scarring, or adhesions. The material in the product eventually absorbs into the body without need for additional surgeries to remove it.
Bands of Scar Tissue May Form
Adhesions are fibrous bands of scar tissue that may form after surgery or infection. They are most common in the abdomen, pelvis, and chest. Adhesions which form on the heart, called cardiac adhesions, may restrict the movement of the heart and interfere with cardiac activity.
There are approximately 500,000 open heart surgeries performed each year in the United States, with as many as 20 percent being repeat procedures, which carry a greater risk of infection and complications. Repel-CV is intended for patients age 21 and younger who are likely to require additional heart surgeries, officials said.
Clinical Tests Show Improvement
As many as 400,000 children in the United States have congenital cardiac abnormalities, including neonatal and infants who must undergo surgeries over many years to correct the defects. The Repel-CV can be helpful in such cases to prevent the formation of scar tissue on and around the heart following the repeated procedures, the FDA said.
A clinical study of Repel-CV found that patients who received the product developed fewer severe adhesions around the surgical site. Repel-CV patients formed adhesions on 21 percent of the surgical site, compared to patients who did not receive the product and were found to have severe adhesions occupying 47 percent of the surgical site.
Related posts:
- Combo Device Stops Irregular Heart Beats, Cuts Heart Failure Risks, Research Says Medical researchers say a new two-in-one heart device can correct...
- Common Heart-Bypass Surgery Technique Said to Increase Risk of Heart Attack If you are among the nearly half-million Americans who will...
- For Diabetics With Heart Disease, Drugs are Just as Good as Surgery, Researchers Say People with type 2 diabetes and heart disease do just...
- Costly, Controversial Heart Failure Surgery Called ‘Ineffective’ Ventricular reconstruction, a controversial, risky, and expensive surgery designed to...
- Post-Gastrointestinal Tumor Surgery Drug May Prevent Tumor Recurrence, Researchers Find Gleevec, a Novartis drug for treatment of patients who have...
