Xeltis to Begin First Clinical Study of Its Tissue-Engineered Vascular Grafts

[TECH NEWS]

Xeltis, a biomedical technology company developing growing, living and self-healing cardiovascular implants using tissue-engineering technology, has announced conditional approval by the Paul Erlich Institute (PEI) in Germany to commence the first clinical study of its tissue-engineered cardiovascular grafts. The prospective, single-center study will evaluate the safety and efficacy of Xeltis’ autologous tissue-engineered vascular grafts in pediatric patients requiring completion of a total cavo-pulmonary connection (TCPC). Sponsored by the University of Zurich, the trial will include up to 10 patients and will be performed at Heart Center Leipzig, Germany (HZL). “Due to their expected longevity, ability to grow and very low risk of thrombosis and infection, these new grafts hold the promise to deliver life-saving therapy for children born with cardiovascular defects. We very much look forward to enrolling our first patient in this important trial,” said Prof. Friedrich-Wilhelm Mohr, director of the heart surgery department at HZL. Children implanted with today’s grafts face the critical problem of outgrowing their implants, requiring them to undergo one or more reoperations. Because Xeltis’ implants have the ability to grow as the child grows, they may remove the need for reoperations.

 Dec 6, 2011, Business Wire