Integra LifeSciences Announces CE Mark and European Launch of Integra Smart Cervical Solution

Integra LifeSciences Holdings Corporation has received European CE Mark approval for its Integra Smart Cervical Solution, a device designed to treat degenerative cervical spine diseases that require stabilization and fusion of two or more cervical vertebrae.

“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.

Delivered sterile, in a double-blister pack, the Integra Smart Cervical Solution combines a cervical cage with a 100 percent 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 helps provide a more secure way to perform the surgery.

The anatomical shape of the cervical cage provides stability and allows a lordotic effect. The cage is made of PEEK-OPTIMA biocompatible, radiolucent polymer that allows clear assessment of bony fusion, according to the Plainsboro, N.J.-based company. The cervical cage contains tantalum markers to help identify the location of the implant radiographically. The synthetic bone substitute is made of ß-TCP (pure phase beta-tricalcium phosphate), which is fully resorbable and has a macroporous structure allowing vascularization and cell colonization.

“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 of Sales and Marketing, Orthopedics (in Europe, Middle East and Africa). “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.”

Integra Smart Cervical Solution is sold by Integra’s European, Middle East and Africa Spine and Orthobiologics sales organization, based on CE marking.

Integra LifeSciences offers solutions in orthopedic extremity surgery, neurosurgery, spine surgery, and reconstructive and general surgery.