Guayule continues to provide innovative solutions for medical devices
One medical product made from Yulex® Natural Rubber, examination gloves from Yulex Corp., already has 510(k) FDA approval but there’s another product expected to receive the same approval later this year. TechDevice Corp., makers of a new guayule natural rubber balloon catheter, plan to file their submission with the FDA during the second quarter of 2009 and approval is expected soon thereafter.
According to TechDevice, guayule is a natural choice with its improved physical, chemical and biological properties over high-end synthetic materials often used in balloon catheters. It’s also more effective with better tensile strength than enzyme-treated tropical natural rubber latex. Extensive testing data from the Yulex 510(k) application for exam gloves also will help as TechDevice moves forward with its submission to the FDA.
Though TechDevice initially will use Yulex Natural Rubber for the development and manufacturing of three balloon catheters, the company believes that catheter balloons are only the first part of numerous possibilities for devices incorporating guayule.
For more information on this development, see the Jan/Feb 2009 issue of Medical Product Outsourcing.
