REVA Medical, Inc., a San Diego, CA company, is testing its promising bioreabsorbable polycarbonate stents in clinical trials in Germany and Brazil, according to a press release from Rutgers University. Dr. Joachim Kohn, Director of the New Jersey Center for Biomaterials at Rutgers, was principal developer of a tyrosine-derived polycarbonate material employed in the stent.
Here’s what the company says about it all:
Coronary artery disease is currently treated by the placement of a metal stent that serves as a permanent scaffold for the vessel. However, it is now generally believed that a stents purpose is fully served upon vessel healing. The REVA Bioresorbable Coronary Stent is designed to act as a temporary scaffold during the healing process. Once the vessel has healed, the stent is designed to resorb, leaving the patient free from a permanent implant.
A bioresorbable stent may eliminate concerns regarding incomplete healing and late-stage thrombosis in stent patients, as well as reduce the need for long-term medication…
Bioreabsorbable stents have many inherent advantages over permanent metal devices currently used to treat narrowing of the arteries of the heart and other areas of the body. Metal drug-eluting stents are limited to a thin polymer matrix for drug delivery. A bioreabsorbable polymer stent can potentially deliver a greater drug payload over a longer period of time to limit the occurrence of localized restenosis, or re-narrowing, of vessels. This type of stent also presents a unique opportunity to locally deliver two or more drugs over multiple time scales to treat a variety of clinical conditions. Once the drug is delivered and vessel function is restored, the polymer will be completely resorbed, leaving no permanent implant behind.
The polymer is combined with the REVA Medical slide-and-lock technology, a highly innovative stent design that allows deployment without significant deformation of the stent structure. This is a major advantage as polymers are not as resistant to deformation as metals. Commented Robert K. Schultz, PhD, President, REVA Medical; “The slide-and-lock technology allows REVA to create fully bioreabsorbable stents Â something traditional deformable stent designs simply can’t achieve. REVA’s stent design is a highly differentiated piece of intellectual property that presents a clear path to stent commercialization. We are aggressively pursing strategic partnerships to successfully bring this technology to market.”
In-vivo studies have demonstrated that stents with the slide-and-lock design can be made of poly(DTE carbonate) and be successfully deployed in femoral and coronary porcine arteries using standard balloon deployment. According to Dr. James Anderson, MD, PhD, Case Western Reserve University, “Histological evaluation of poly(DTE carbonate) stents at 28 days in porcine arteries revealed a normal healing response with a normal foreign body reaction at the tissue/material interface and no acute and/or chronic inflammation.” Additional work with poly(DTE carbonate) as an anti-restenosis drug-delivery vehicle demonstrates the significant potential of this polymer for vascular applications. Together these studies are of major significance as they illustrate the potential of these novel stent materials and designs in the treatment of vascular disease.
To read more about the stent, head on to REVA Bioresorbable Coronary Stent product page.
Rutgers press release: Rutgers Biomaterial Debuts in Clinical Trials of New Stent …
Press release: Novel Bioresorbable Coronary Stent Begins Clinical Evaluation …