Germany-based medical technology company joimax has secured the US Food and Drug Administration (FDA) approval for its Intracsem, an electromagnetic navigation tracking and control system for minimally invasive endoscopic spinal surgeries.

The company said that its Intracsem Navigation System would facilitate conducting spinal procedures with minimal X-ray control, reduced exposure to radiation, access time, and the duration of surgical procedure.

Preliminary trials head Michael Kraus said: “Using Intracsem Navigation System in the full endoscopic spine surgery is safe and easily applicable. The technology helps master precise access to the spine, and the clinical trials have confirmed the technique’s multiple advantages.”

Intracsem system evaluated in cadaveric trials conducted in Germany and US

The company has developed Intracsem system in a multiyear programme, with first cadaveric trials conducted by a group of surgeons at the ESPINEA Labs in Karlsruhe, Germany and Irvine, California.

Established in 2001, joimax is engaged in developing and marketing comprehensive medical devices for endoscopic and minimally invasive spinal surgery.

The company’s product portfolio includes the Endoscopic Surgical Systems TESSYS, iLESSYS  and CESSYS for decompression procedures, MultiZYTE for sacroiliac joint pain treatment, EndoLIF and Percusys for assisted stabilization, addressing a wide range of indications.

Joimax said that all of its instruments and scopes are capable of being tracked and precisely navigated with help of suitable sensors.

Chris Hofstetter from UW Medical Center said: “joimax Intracsem constitutes a highly precise image-guided navigation platform designed for the specific needs of full-endoscopic spine surgery.

“Using electromagnetic navigation technology allows to track the leading edge of endoscopic instruments in real time, and facilitates needle targeting and orientation during the surgery, while minimizing radiation exposure.

“No doubt, this technology will expand the indications for full-endoscopic spine surgery and pave the way for innovations in minimally invasive arthrodesis techniques.”