U.S medical device company ProPep Surgical has announced the FDA 510(k) clearance for its ProPep Nerve Monitoring System. The ProPep family of products allows surgeons to do intraoperative nerve monitoring during minimally invasive, robotic-assisted surgery for prostate cancer.
ProPep Surgical is a privately-held, Austin-based medical device company developing products to aid robotic surgeons in identifying the location and monitoring the integrity of otherwise invisible nerves during minimally invasive surgery.
For decades surgeons performing open surgery have been using intraoperative nerve monitoring to provide real-time, accurate information on the location of nerves vital to a patient’s recovery.
Use of nerve monitoring technology is considered standard of care in maxillofacial surgery, orthopaedic surgery, and neurosurgery. This groundbreaking technology has not, however, been available to robotic surgeons, a situation that has changed wit FDA’s clearance of ProPep’s system.
The company says its 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.
“Now that we have received our 510(k), the Company will begin actively marketing its ProPep Nerve Monitoring System in the US,” stated Jim Schneider, Chief Operating Officer. “We look forward to working with surgeons to improve the quality of life of their prostate cancer patients.”
Source: ProPep Surgical, LLC.