CE Mark And EU Launch Of Integra® Smart Cervical Solution

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

Background

The anatomical shape of Integra’s 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. The cervical cage contains tantalum markers to help identify the location of the implant radiographically. The synthetic bone substitute is made of 100% ß-TCP (pure phase beta-tricalcium phosphate), which is fully resorbable and has a macroporous structure allowing vascularization and cell colonization.

Delivered sterile, in a double-blister pack, 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 helps provide a more secure way to perform the surgery.

Company comments

“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 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 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.

Note: PEEK-OPTIMA is a registered trademark of Invibio Limited

Source: Integra Lifesciences Holdings Corporation