CE Mark For Checkpoint® Neuroprotective Stimulator Device

In short

Cleveland, Ohio-based Checkpoint Surgical has announced that it has gained CE mark clearance for its CHECKPOINT® Stimulator/Locator, a state-of-the-art intraoperative neuroprotective stimulator that helps surgeons locate, identify and evaluate nerve and muscle excitability during surgery to facilitate nerve preservation and repair.

Background

According to a news release from Checkpoint, there are more than 2 million annual surgeries in the U.S. alone where nerve damage is a major risk, representing an annual global revenue opportunity in excess of $500 million, giving us a clue that the device costs around $250.

Checkpoint Surgical was founded in 2009 in Cleveland, Ohio, and CHECKPOINT® received FDA clearance in the U.S. in October 2009. In 2010, the company launched U.S. sales of the product, which is now used in a wide range of nerve repair, ENT, orthopaedic, plastic reconstructive, and oncological surgical procedures at many of the nation’s premier hospitals.

Checkpoint Surgical has already engaged distribution partners in Australia and South Africa and will be launching sales there in the very near future. The company is presently in discussions with distribution partners in major European markets.

Clinician comments 

“Innovative surgeons around the world believe that CHECKPOINT® will be a useful tool in the further development of safer, less invasive surgical techniques,” said Checkpoint Advisory Board Member Michael Hausman, M.D., vice-chairman and chief of Hand and Elbow Surgery in the Department of Orthopedics at Mount Sinai Hospital in NYC. “We look forward to their collaboration and contributions.”

Company comments

“CE mark opens up significant additional markets for our products,” said Len Cosentino, CEO and president of Checkpoint Surgical. “We’ve received tremendous interest in the CHECKPOINT® over the past year from distributors and surgeons in overseas markets and we’re excited to now put it in their hands.”

Source: Checkpoint Surgical