Pro-Prep Surgical Medical Device Company Gets FDA approval for It’s Nerve Monitoring System To Be Used During Minimally In
Posted Jul 05 2012 5:21pm
What robot performs prostate cancer surgery, the daVinci and the device helps surgeons identify nerves that may otherwise not be visible. If you read the news there have been a few incidents reported with the robot, I have not seen a lot but there are some. The device consists of a Pep monitor, a control switch and an electrode kit. The kit is a single use disposable unit. The electrode connects to the monitor. This appears to make the procedure and the robot safer. BD
ProPep Surgical, a privately-held, Austin-based medical device company, announced today it has received FDA 510(k) clearance for its ProPep Nerve Monitoring System – a family of products that allows surgeons, for the first time ever, to do intraoperative nerve monitoring during minimally invasive, robotic-assisted surgery for prostate cancer.
The ProPep Nerve Monitoring System is the first real-time nerve monitoring system specifically designed for use during robotic-assisted radical prostatectomy , the most common treatment for prostate cancer. Fast, accurate and easy to use, the System gives the surgeon real-time feedback regarding the location and integrity of otherwise invisible nerves during robotic-assisted radical prostatectomy. “One of the biggest fears about prostate cancer surgery is the potential for nerve damage. To reduce the side effects associated with this nerve damage, the surgeon must do two things; spare the nerve tissue, and not damage the nerve tissue while sparing it,” according to Dr. Randy Fagin , Chief Medical Advisor.
“Currently, surgeons rely on anatomic landmarks to identify nerves during surgery but research has shown these landmarks are not always reliable and even if you successfully spare the nerve tissue, there has never been a way of knowing, in real-time, how much damage was done to the nerve while trying to sparing it.” The ProPep Nerve Monitoring System is the first product that provides the surgeon real-time information to not only make a more informed decision about which tissue to selectively preserve or remove during an operation, but to also assess the integrity of the nerve during the procedure. “This information has never been available before. Having it can change a surgeon’s decision making during an operation and could potentially reduce the incidence of nerve damage related side effects such as incontinence,” says Dr. Fagin.