Zod wrote:I'm told that the combination of Medtronic pump and Codman catheter is off-label and therefore needs FDA approval.
Want to confirm or deny that.
The clinical trial says this:
This study is being done to answer the following question:
Is the combination of the Medtronic pump and the Codman catheter device a safe alternative to the C3000 Codman pump for delivering chemotherapy directly into the liver of patients with metastatic colorectal cancer or cholangiocarcinoma?
It's not technically off-label if you're part of the clinical trial. My guess is FDA approval will be necessary to allow the Medtronic pump to be the new standard (replacing the Codman) when the trial is over (September 2020). The Medtronic pump was never used for this purpose, but the catheters are the same ones from Codman. Some large insurance companies like Aetna cover it anyway. ("Aetna considers intra-hepatic chemotherapy (HAI pump) medically necessary for members with liver metastases from colorectal cancer.")
Codman was an idiot for discontinuing the pump! https://clinicaltrials.gov/ct2/show/NCT03693807