FDA approves PU catheters made by Avalon
Surbiton, UK - US catheter maker Avalon Laboratories llc has received 10(k) approval from the US Food and Drug Administration (FDA) to market its new Avalon Elite range, made with Elast-Eon, a biostable polyurethane elastomer with a high silicone content. Elast-Eon is a patented product of UK-headquartered medical polymer and device developer AorTech International plc. According to Aortech, this use will involve "substantive volumes of polymer sales for the company," in future.
In a 25 Nov statement, AorTech said that Avalon's top of the range Elite catheters use "innovative engineering and broad proprietary manufacturing technologies," and can help in better care for patients suffering from debilitating diseases.
FDA approval will allow full commercial launch of the catheters in the US. AorTech added that they have "performed extraordinarily well," in limited clinical trials in Europe earlier this year.
Describing its relationship with Avalon as "an excellent fit for AorTech," Frank Maguire, AorTech ceo said, "Our ISO-certified manufacturing facility was designed specifically with this type of bulk polymer business in mind."
For Avalon, ceo Robert Foster said, "The Elast-Eon material has some remarkable properties and it has found important applications in several implantable products. We have been extremely impressed with this innovative material and believe it will provide a tremendous benefit to the Avalon Elite."
Another recent supply agreement announced in August for Elast-Eon was with an un-named company in the $300-million per year arterio-venous (AV) fistula market in the US. That deal included $250 000 in milestone payments, provisions for polymer sales and a single digit royalty, said AorTech,
"The use of Elast-Eon in vascular connectors is a natural extension of the portfolio of uses in other blood-contacting products. Elast-Eon's best in class biostability, processibility and blood-contacting performance make it an excellent choice for this application," said Maguire.
As well as having similar biostability to silicone elastomers, AorTech says Elast-Eon has "excellent mechanical, blood contacting and flex-fatigue properties." It can also be processed as a thermoplastic by extrusion or moulding.