CE-Zertifizierung Vascular Patch
2012-01-12 12:52
This week NonWoTecc Medical GmbH received the CE-mark for its first vascular device, the vascular patch. The product is classified class III, the most stringent category.
“With this certification NonWoTecc reached an important milestone,” said Frank Willems, co-founder and managing director of NonWoTecc. The vascular patch will be the first product that NonWoTecc has developed since its start in 2007 that receives marketing approval in Europe. The patch will be launched commercially in the middle of the year through country exclusive vascular distributors. The selection process has started in the meanwhile.
Compared to the existing patches that are on the market the NWT patch has several advantages that are relevant in the vascular surgery: There is no stich wound bleeding, there is no tearing of the sides, and the product can be cut easily into the desired shape. The base material shows a very low thrombogenicity and is properly elastic.
“The vascular patch is made of a special grade PCU (Poly carbon urethane) that will form the basis of an all new vascular graft product line,” said Christoph Claßen, co-founder and COO of the company. The main target for NWT is the successful development of a coronary bypass.
NonWoTecc develops vascular grafts based on a novel technology platform that mimics the human extracellular matrix. The next graft, an upper leg artery replacement graft, is currently in a multicenter clinical trial and the first patients that have been implanted reached the 20 months period.
“This CE certification is a great way to start the New Year, and will prove to be an important basis for the rolling out of our product pipelines” according Harrie van Baars, managing director of NonWoTecc Medical GmbH.
About NonWoTecc Medical GmbH
NonWoTecc Medical GmbH was founded in 2007. The goal of the company is to develop vascular grafts and covering of vascular stents. It is financed through venture capital (Among others Rheinland Venture Capital, High-Tech Gründerfonds, KSK Wagniskapital, KfW Bankengruppe, NRW Bank, and several private investors)
Contact:
NonWoTecc Medical GmbH
Nattermannallee 1
50829 Cologne, Germany
Tel: +49 221 9922 470