Columbus, Ohio’s Minimally Invasive Devices, Inc., (MID) has been awarded CE Mark Certification for its FloShield laparoscopic visualization system, clearing the way for sales throughout the European Union.
The FloShield system provides for an uninterrupted clear view during laparoscopic procedures, using airflow from the insufflator to defog and deflect debris from the laparoscope lens without removing the scope for cleaning. Surgeons have to interrupt surgery as often as ten times per hour to remove the scope and manually clean it. FloShield dramatically reduces, and often eliminates, interruptions to clean the lens.
“The advent of HD ten years ago was the last breakthrough in laparoscopic vision,” says Wayne Poll, M.D, FloShield inventor and CEO of MID. “FloShield represents the last hurdle in laparoscopic visualization.”
The FloShield system, which received FDA 510(k) approval in 2008, is in early distribution within the U.S., and in use at approximately 40 hospitals throughout the country. The system was certified ISO 13485 compliant in December of 2010, clearing the path for CE Marking.
FloShield is manufactured in Franklin, Ohio. Poll says the company has more than tripled employment over the last two years from four full time employees to 14. The company was featured in a recent CNNMoney.com video report on Ohio’s biomedical industry growth.