Titan Medical (NSDQ:TMDI) said it has upgraded its SPORT robotic surgical system in anticipation of applying for FDA and CE Mark clearances. In 2018, the company delayed its expected 510(k) submission date.
TheToronto-based company’s single-port system is designed for minimally invasive surgery. Based on its preclinical experience, the company redesigned its dual-camera system. SPORT now has a 3D high-definition steerable endoscopic camera for use during surgery and a 2D high-definition wide-angle camera integrated into the camera insertion tube for visualization of instrument insertions and to serve as a backup camera for safety.
Titan’s engineering team also designed a more compact and significantly lighter patient cart to optimize portability, minimize set-up time and facilitate use at the patient bedside. The company also said it improved the surgeon interface at the workstation with a more comfortable handle design, a new 4K monitor, and upgraded haptic feedback with image overlays to assist the surgeon with the positioning of the instruments for optimal performance.
Surgeons performed 45 preclinical studies with Titan’s earlier SPORT system prototype, including 14 different procedures within four surgical disciplines, according to Titan president & CEO David McNally.
“As a result, our single-port robotic system now incorporates multiple important and patent-pending enhancements specifically intended to improve surgical performance and ease of use, which will better position us in the rapidly-expanding surgical robotics market,” McNally said in a prepared statement.
For the first half of 2019, Titan plans to finish verification and validation testing. The second half of the year will be focused on implementing its IDE study and filing its 510(k) submission, the company said.