AngioDynamics (NSDQ:ANGO) said yesterday that it won central Institutional Review Board approval to run a clinical study of its NanoKnife irreversible electroporation system seeking an indication for use in treating Stage III pancreatic cancer.
The Lantham, N.Y.-based company said that the approval will accelerate its engagement with local IRBs and will hasten its DIRECT clinical study.
AngioDynamics said that the DIRECT clinical study will support a regulatory indication for treating Stage III pancreatic cancer with its NanoKnife system. The study will also be used to support reimbursement for hospitals and treating physicians, the company said.
The DIRECT clinical study is a randomized controlled trial being at 15 sites, as well as a real-world evidence, next-gen registry at up to 30 sites with a NanoKnife system treatment arm and control arm. The company expects that each arm of the trial will consist of 250 patients with an equal number of control patients.
The primary endpoint for the DIRECT trial is overall survival, AngioDynamics said.
“AngioDynamics is committed to providing physicians and patients with additional options for the treatment of Stage III pancreatic cancer. The Direct IRB approval demonstrates our commitment to initiating this next-generation clinical study as quickly as possible to advance our pursuit of innovative, lifesaving treatments,” oncology GM Brent Boucher said in a press release.
Yesterday, AngioDynamics said it is selling its Namic fluid management business to Medline Industries for $167.5 million.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.