Integra LifeSciences Holdings Corporation has received the European CE Mark for its device called the “Smart Cervical Solution” that is delivered to the surgeon in a sterile, double-blister pack. The device is designed to treat degenerative diseases of the cervical spine that require stabilization and fusion of two or more cervical vertebrae.
According to the June 26 news release, the Integra Smart Cervical Solution combines a cervical cage with a 100% synthetic bone substitute. The implant is pre-filled and attached to a disposable inserter, which enables a “NO TOUCH” surgical procedure, because the substitute already fills the cage. The disposable inserter has a built-in depth stop, which, company officials say, helps provide a more secure way to perform the surgery.
The cage, which has an anatomical shape, is made of PEEK-OPTIMA biocompatible, radiolucent polymer that allows clear assessment of bony fusion. The synthetic bone substitute is made of 100% pure phase beta-tricalcium phosphate, which is fully resorbable and has a macroporous structure allowing vascularization and cell colonization.
“Integra worked closely with a group of surgeon advisors to make a user-friendly device, and developed an all-in-one design that helps save time and ensures more ease of use, ” said Debbie Leonetti, Integra’s President, International.
“We’re very pleased to be able to introduce our new device in the European market and provide surgeons with more treatment options, ” said Stephane Corp, Integra’s Vice President, Sales and Marketing, Orthopedics. “In addition to being a surgeon-friendly device that helps streamline the procedure, the synthetic bone substitute of the Integra Smart Cervical Solution may help spare patients an additional surgery to harvest their own bone, limiting the risk of any associated complications.”
