Research by Prof. Daniel Cohn of the Hebrew University could lower the risks of scar tissue in children undergoing multiple heart operations.

For children undergoing multiple heart surgery, the risks of vascular or cardiac injury are high. Scar tissue from previous procedures can either affect the functioning of the heart or obscure vital cardiac landmarks, making it difficult for surgeons to carry out the delicate and precise treatment required to make the operation a success.

Now a new biomedical product developed originally at the Hebrew University of Jerusalem, could change all that. The technology, which is being commercialized by US biomaterials company SyntheMed, is a tailor-made biodegradable polymer designed to prevent scar tissue in the wake of a surgery.

Called Repel-CV Adhesion Barrier, the product is a transparent bioresorbable film that can be inserted over the heart following open-heart surgery. The polymer, which degrades naturally, reduces the severity of scar tissue that forms between the surface of the heart and nearby tissue surfaces during the healing process.

According to the company, the product is easy to use, requires no changes to surgical technique and adds minimal time to the surgical process.

The Repel-CV, which is the first anti-adhesion product for cardiac surgery on the market, has been approved by the US Food and Drug Administration (FDA), for use in pediatric cardiac surgery patients (21 and younger), who are likely to need secondary open-heart surgery.

The end of a long process

“I am very excited that the long process started several years ago in our laboratory at the Institute of Chemistry of the Hebrew University with the design and synthesis of a family of biodegradable polymers was recently approved by the FDA,” said Prof. Daniel Cohn, the award-winning Israeli professor who invented the polymer.

Today in the US, there are some 350,000 to 400,000 children with congenital cardiac abnormalities. Many of these children must undergo multiple surgeries to correct the defect, while others require additional operations as they grow. Each of these surgeries leaves a scar, and in some cases, these adhesions can be life threatening.

Cohn’s biomedical product harnesses the unique properties of a class of custom-made, biodegradable polymers.

“Each and every surgery conducted inevitably results in post-surgical adhesions, and the polymeric film developed at the Hebrew University allows us to minimize those adhesions,” said Cohn, who won first prize in last year’s Hebrew University Kaye Awards for Innovation, for his work on polymers.

A widespread problem

The problem of post-operative adhesions is widespread and SyntheMed, which is based in New Jersey, bought the technology from Hebrew University through Yissum, the university’s technology transfer company. The company developed the product and brought it to the clinic.

FDA approval came after SyntheMed, which specializes in developing and commercializing anti-adhesion products, received regulatory approval in Europe and Canada.

In clinical trials conducted at 15 pediatric cardiac surgery centers throughout the US, over 70 percent of the children treated with Repel-CV were completely free of clinically-significant adhesions, the most severe grade of scar tissue measured, compared to less than 30% of control patients.

The company is now developing a range of anti-adhesion products based on Cohn’s polymer technology.