The company’s US pivotal study is designed as an adaptive, randomized controlled trial at up to 30 sites in the US. Enrollment in the trial is expected to last through 2009, and will include a minimum of 246 patients.
Mark Tauscher, president and CEO of PLC, said: “We are very pleased with the FDA’s conditional approval to the investigational device exemption supplement we filed in February, 2008. This will enable us to commence our pivotal study on schedule this spring.”