News | October 07, 2008

First Human Use Announced of Finale Prohealing Coating Technology on PROTEX Stent

October 8, 2008 - SurModics Inc. today said the PROTEX Coronary Stent System incorporating SurModics’ proprietary Finale prohealing coating technology was used in the first-in-human trial evaluating the safety of the device for the treatment of coronary artery disease.

The PROTEX stent was developed by Nexeon MedSystems Inc. (formerly Paragon Intellectual Properties LLC), a developer of medical technology for the treatment of cardiovascular disease. The first implant procedure was performed by Professor Eberhard Grube, chief of cardiology and angiology, at the Heart Center Siegburg in Siegburg, Germany as part of Nexeon MedSystems’ PROTEX I clinical trial.

The FINALE prohealing coating technology integrates extracellular matrix proteins that accelerate tissue repair through the body’s own healing mechanisms by attracting endothelial cells from the surrounding tissue and circulating endothelial progenitor cells, the company said. The PROTEX Stent System utilizes Nexeon’s unique low-profile (0.86mm) cobalt alloy coronary stent platform and is designed to address late stent thrombosis, a serious complication occurring in a small percentage of coronary stent cases, while also aiming to reduce restenosis, or the re-narrowing of the stented vessel. The PROTEX Stent System may eliminate the need for long-term antiplatelet therapy, thereby decreasing costs and reducing bleeding risks to the patient, the manufacturer said.

Nexeon believes the FINALE prohealing coating technology holds promise to speed recovery of the normal vessel architecture and inner cell lining to significantly reduce the risk of late stent thrombosis, while also reducing restenosis.

The PROTEX I clinical trial will enroll 50 patients at up to five sites in Europe. Follow-up examinations will be performed at 30 days, six months and nine months. The six-month follow-up examination will evaluate both neointimal volume by intravascular ultrasound (IVUS) and percent binary restenosis by angiography. Dr. William Wijns, M.D., of the Cardiovascular Center Aalst in Belgium, will serve as the principal investigator of the clinical trial.

“There is a significant clinical need for a low-restenosis stent that does not carry the late-thrombosis risk of drug-eluting stents,” said Dr. Wijns. “I am excited about the potential of this type of breakthrough coating on a highly deliverable coronary stent.”

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