Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.PLC Systems, a medical technology company, has received full approval from the FDA for its US pivotal trial to study the effectiveness of the company's RenalGuard system and associated therapy in the prevention of contrast-induced nephropathy.
Subscribe to our email newsletter
The FDA also approved PLC’s request to expand their investigation from the 246 patients conditionally approved earlier this year to 406 patients and eliminate the requirement for an interim study analysis to be performed. As a result of this and other changes, the study is no longer considered an adaptive study.
Mark Tauscher, president and CEO of PLC, said: “We are very pleased with the FDA’s full approval to the investigational device exemption (IDE) supplement we filed in February 2008 to study RenalGuard in the US.
“Full FDA approval of the IDE supplement is another major milestone on our path forward to commercializing RenalGuard in the US, and with its receipt, we are well-positioned to begin the trial with our targeted study sites, once we have the needed funding.”