Integra LifeSciences Announces CE Mark and European Launch of Integra(R) Smart Cervical Solution
PLAINSBORO, N.J., June 26, 2013 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced that it has received European CE Mark for its Integra® Smart Cervical Solution, a device approved in the European Union for treating degenerative diseases of the cervical spine 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% 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. 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.
"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 Smart Cervical Solution is sold by Integra's European, Middle East and Africa Spine and Orthobiologics sales organization, based on CE marking.
Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, spine surgery, and reconstructive and general surgery. For more information, please visit www.integralife.com
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the products and services provided by Integra. Such forward looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of surgical professionals to use Integra products may affect the prospects for their use in surgical procedures. In addition, the economic, competitive, governmental, technological and other factors, identified under the heading "Risk Factors" included in Item IA of Integra's Annual Report on Form 10-K for the year ended December 31, 2012 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.
PEEK-OPTIMA is a registered trademark of Invibio Limited.
CONTACT: United States:
Integra LifeSciences Holdings Corporation
Gianna Sabella
Director, Corporate Communications
(609) 936-2389
gianna.sabella@integralife.com
International:
Integra LifeSciences Services (France)
Marie-Anne Girel
Manager, Communications
Europe, Middle-East, Africa
marie-anne.girel@integralife.com