A Shelton company said it has won Food and Drug Administration clearance to expand the use of a medical device it originally developed to simplify bone grafting procedures for orthopedic surgeries.
Avitus Orthopaedics said Tuesday the latest regulatory clearance will allow it to market its Avitus Bone Harvester technology as a minimally invasive way to remove infected or diseased bone.
The clearance allows for the use of the device “to debride and capture infected, necrotic or diseased cancellous bone, such as in the removal of osteomyelitis and cancellous bone tumors,” the company said in a news release.
The device’s suction-powered technology offers a faster, less invasive way to remove diseased bone, according to the company.
The collected tissue is contained within the handle of the device, allowing for easy transport of the diseased bone. This lessens the risk of exposing healthy tissue or contaminating other instruments or the surgical site, the company said.
Co-founder and CEO Neil Shah said its technology initially was developed as a way to provide surgeons with a better way to obtain high-quality autograft and marrow for their patients. But many surgeons said they would also benefit from using the device to remove bone tumors and infected bone, he said.
“We are thrilled to now offer them a solution,” he said in a statement.
The company was founded by engineers and surgeons at the Johns Hopkins Center for Bioengineering Innovation and Design.
Contact Natalie Missakian at news@newhavenbiz.com
