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Vascular stent that dissolves on its own

The first ever implant in Germany of a bioresorbable, drug-coated stent in a cardiac patient has been carried out by physicians from the University of Heidelberg. In contrast to traditional metal stents, which remain permanently in the patients’ body, the innovative implant dissolves around two years after the procedure is carried out.

The study uses a bioresorbable temporary stent 2.5 or 3 millimetres long that is inserted into the constricted cardiac vessel using a balloon catheter © 2011 Abbott Laboratories

Stents are artificial tubes with mesh-like structures that are inserted into one of the body’s natural passages (cardiac vessels, for example) to prevent or counteract localised flow constriction. For the first time ever in Germany, physicians from the University Hospital of Heidelberg have recently implanted a drug-coated bioresorbable stent into a patient suffering from coronary heart disease. In contrast to traditional metal stents, which remain permanently in the patients’ body, the innovative implant dissolves around two years after the procedure is carried out.

“The advantage of the stent system is that the constricted vessel can potentially regenerate and take up its natural functions again,” explains Professor Dr. Hugo A. Katus, Medical Director of the Department of Cardiology, Angiology and Pneumology. “The vessel is able to regain the ability to move and pulsate, both of which are key functions.” “The surgery went smoothly,” added senior physician Dr. Raffi Bekeredjian who implanted the stent into the coronary vessel. “The patient is doing very well and was able to leave hospital the day after surgery.”

Reduces thrombosis risk in the long term

The bioresorbable stent, which is currently only available for study purposes, is made of polylactide, a biocompatible material that is also used for the production of self-dissolving suture material. In addition, the stent is coated with a drug to prevent the vessel from closing again. Since the implant dissolves on its own, the risk of developing thrombosis over the long term is also reduced. This is because blood clots no longer form so easily.

The implantation of the resorbable stent also marks the beginning of a clinical trial in Germany which involves around 1,000 patients from up to 100 study centres around the world. Dr. Bekeredjian is coordinating the contributions of the Heidelberg physicians to the study, which, in addition to Heidelberg University Hospital, also involves the Charité hospital in Berlin. Previous examinations of stent-implanted patients have shown that the procedure did not lead to the formation of blood clots nor did any of the patients develop any other serious heart disease. The examinations also showed that the implant was completely absorbed by the wall of the vessel into which it was inserted. Abbott Vascular, a global leader in vascular and cardiac care, plans to launch the bioresorbable self-expanding stent by the end of next year.

Literature:

Intracoronary optical coherence tomography and histology at 1 month and 2, 3, and 4 years after implantation of everolimus-eluting bioresorbable vascular scaffolds in a porcine coronary artery model: an attempt to decipher the human optical coherence tomography images in the ABSORB trial. Onuma Y, Serruys PW, Perkins LE, Okamura T, Gonzalo N, García-García HM, Regar E, Kamberi M, Powers JC, Rapoza R, van Beusekom H, van der Giessen W, Virmani R. Circulation, 30 November 2010.

Shedding light on bioabsorbable stent struts seen by optical coherence tomography in the ABSORB trial. Tearney GJ, Bouma BE. Circulation, 30 November 2010.

A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Serruys PW, Ormiston JA, Onuma Y, Regar E, Gonzalo N, Garcia-Garcia HM, Nieman K, Bruining N, Dorange C, Miquel-Hébert K, Veldhof S, Webster M, Thuesen L, Dudek D. Lancet, 14 March 2009.

A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Ormiston JA, Serruys PW, Regar E, Dudek D, Thuesen L, Webster MW, Onuma Y, Garcia-Garcia HM, McGreevy R, Veldhof S. Lancet, 15 March 2008.


Further information:
Prof. Dr. Hugo A. Katus
Medical University Hospital (Krehl Hospital)
Department of Cardiology, Angiology and Pneumology
Im Neuenheimer Feld 410
69120 Heidelberg
Tel.: +49 (0)6221 56-8670
E-mail: hugo.katus(at)med.uni-heidelberg.de
Website address: https://www.gesundheitsindustrie-bw.de/en/article/press-release/vascular-stent-that-dissolves-on-its-own