FDA Clears ProPep Nerve Monitoring System

Austin, Texas-based ProPep Surgical has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ProPep Nerve Monitoring System. According to the company, this system will be the first one to allow intraoperative nerve monitoring during minimally invasive, robotic-assisted surgery for prostate cancer.

The ProPep system monitors nerves in real-time during surgery, and is designed for use in robotic-assisted radical prostatectomies, the most common treatment for prostate cancer. The system locates and evaluates the integrity of pelvic nerves that are usually invisible during such procedures.

“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,” said Randy Fagin, M.D., chief medical advisor to ProPep. “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. 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.”

The nerve monitoring system consists of three parts:

• The monitor, which generates the specific electrical signal used to stimulate the tissue of interest, and records, analyzes and displays the tissues response to that signal that enables a surgeon to distinguish between nerve containing versus non-nerve containing tissue;
• The control switch, which enables the surgeon to switch the robotic bipolar instrument from bipolar/cautery mode to Pep stimulation mode and back. (The electrical stimulation signal generated by the Pep Monitor is delivered through the surgeon’s robotic bipolar surgical instrument thus eliminating the need to introduce a separate stimulation probe into the surgical field); and
• The electrode kit—a single use, disposable kit containing the electrode and the electrode introducer. The electrodeis connected to the monitor and introduced into the surgical field via the electrode introducer. Once in the surgical field, the electrode is placed in the tissue of interest to receive the electrical signals generated as a result of stimulation.