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Biomaterial-based stent makes clinical trial debut

A revolutionary, new biomaterial, developed at the New Jersey Center for Biomaterials at Rutgers University has moved from the lab bench to field testing in record time.

This achievement, a product of a breakthrough methodology in biomaterials discovery, is the enabling technology behind a coronary stent undergoing its first-in-human clinical trial in Germany and in Brazil.

In collaboration with REVA Medical Inc., researchers developed a polymer that is exceptionally strong and highly suitable for stent applications. In addition, the material was designed to be radio-opaque so it is X-ray visible, a property critical to the proper placement of the stent in the artery. It is also biodegradable and biocompatible.

Stents are tiny tubes inserted into diseased arteries to keep them open. The biomaterial-base stent is designed to act as a temporary scaffold to support the blood vessel during the healing process and maintain blood flow. It subsequently dissolves, leaving the patient free of any permanent implant.

Rutgers' Joachim Kohn showcased his biomaterials discovery process during TCT 2007 (Transcatheter Cardiovascular Therapeutics). Fully degradable coronary stents have been explored for more than 20 years. But, says Kohn, no clinically useful products could be developed, in part, because of the lack of polymers that could meet the extremely demanding performance requirements. Kohn and his team addressed this problem by developing a library of degradable polymers comprising 10,000 theoretically possible compositions and applying combinatorial methods to identify the best possible biomaterial. The resulting material was selected for use in combination with REVA’s novel stent design.

"Our unconventional discovery process integrates combinatorial polymer libraries, high-throughput testing, and computational modeling. This results in a much faster path to prototype development and a reduction in the cost and risk associated with the use of new, proprietary biomaterials," says Kohn.

In addition to REVA, Rutgers has licensed the polymer portfolio to several other companies. One licensee obtained FDA clearance for a new hernia repair device on a three-year track from concept to FDA market clearance. Another is working with Kohn's combinatorial discovery process to identify an ideal polymer for their ophthalmic drug delivery device. The scientific foundations of the new biomaterials discovery process are being developed with support to the New Jersey Center for Biomaterials and the Kohn Laboratory from the National Institute of Biomedical Imaging and Bioengineering of the National Institutes of Health.

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