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Integra LifeSciences Receives FDA Clearance for Integra(R) Titanium Bone Wedges

Integra LifeSciences Holdings Corporation (Nasdaq: IART) today announced the introduction of the Integra® Titanium Bone Wedges, designed for internal fixation for bone fractures or osteotomies in the foot and ankle. The system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), and will be featured at the American College of Foot and Ankle Surgeons (ACFAS) 72nd Annual Scientific Conference, February 27 – March 2, 2014, in Orlando, Florida.

The Integra Titanium Bone Wedges may be used in corrective procedures, such as Cotton (opening wedge) osteotomies of the medial cuneiform and Evans lengthening osteotomies. They are composed of commercially pure titanium formed into a cancellous-like structure that mimics the strength and porosity of human bone. The Integra Titanium Bone Wedge is available in 15 different pre-shaped anatomical sizes, to accommodate various skeletal deformities in the foot.

"We're very pleased that we can now offer surgeons another option to complete our flatfoot correction portfolio," said Robert Paltridge, President, Extremity Reconstruction. "Our Titanium Bone Wedges provide more stability over allograft wedges. Additionally, our extensive line of pre-shaped bone wedge implants does not require custom shaping, which helps reduce surgical time."

Osteotomies are procedures in which surgeons realign or remove a segment of bone located near a damaged joint to help correct deformities, typically in the foot. Bone wedges are designed to provide bone grafting material for osteotomy corrections. They provide a scaffold for bone growth, as well as biologic stability and structural support for deformity corrections. Ancillary plates are used to hold bone graft material in place and prevent it from expulsion.

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.

Posted-In: News FDA

 

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