Spinal Placement Device Ready for Market
The U.S. Food and Drug Administration granted approval to Mazor Surgical Technologies, Limited for their SpineAssist device. The robotic tool supports intraoperative placement of spinal implants, as described in an article on Healthcare Sales and Marketing Network.
SpineAssist uses CT imaging before surgery to identify the ideal anatomic location for placement of a spinal implant. Also included is a miniaturized device that is placed above the patient’s spine combined with a workstation that operates advanced surgical planning software; these two components are used during surgery.
The software supports planning before surgery, using the imaging studies and device templates to determine the ideal placement of the appropriate device within the spine. The software then provides animation of the planned correction to determine functional correction.
The workstation controls the movement of the robot during the implantation procedure. The workstation is also connected to a C-arm fluoroscopy tool. CT imaging and studies from fluoroscopy are linked together by the software to guide the implantation. The software then guides the robot to the location identified during planning.
Compared to alternatives to support placement of spinal implants, this solution reduces the amount of radiation exposure to patients. Surgeons have generally relied on fluoroscopy imaging intraoperatively to guide and verify placement. Additionally, the Spine Assist system mitigates the need for surgeons to cut through the patient’s back to complete visual assessment of the spine in order to determine placement.
Exact device placement is critical for a number of reasons. First, placing the device in the optimal location offers the best opportunity to treat the disease which necessitated intervention. Second, the spinal anatomy is incredibly complicated; placement must consider surrounding nerves and tissues.
The FDA approval for the device includes use of such during both minimally invasive and open surgical approaches used for implantation of spinal devices. Moreover, it can be used for placement of any type of spinal implant.
September 7, 2007 Related topics: Product Approval & Certification, Quality, Safety, Errors, Orthopedic