Industry News

FDA Requires Postmarket Studies for Spine Stabilization Devices

The U.S. Food and Drug Administration (FDA) has ordered manufacturers of certain types of pedicle screw systems to conduct postmarket safety studies.

“Currently, there is not enough clinical data to determine whether these dynamic stabilization systems provide enough spinal stability to allow for complete spinal fusion, as the system components may loosen, bend, or break over time,” a news release about the order stated. “If fusion does not occur, a patient’s condition could worsen and possibly require additional surgical procedures.”

In addition to the postmarket safety studies, the FDA now requires manufacturers of new pedicle screw systems to submit clinical information to the agency before marketing the product.

FDA officials said they would review the clinical data gathered during the postmarket review process and consider whether labeling changes or additional preclinical and clinical testing requirements are necessary.

All postmarket safety studies, according to the FDA, must address:

• The fusion rate for pedicle screw systems compared to traditional stabilization systems.

• The incidence rate, severity, and time course of adverse events for dynamic stabilization systems compared with traditional systems.

• The type, incidence rate and time course of subsequent surgical procedures for dynamic stabilization systems compared with traditional stabilization systems.

• The cause of failure for dynamic stabilization systems based on analysis of all reasonable available systems that have been removed from patients, along with any association between the patient’s demographic and clinical data and the device failure.

Traditional, rigid stabilization systems have been on the market for decades, according to FDA data. They provide stability through screws inserted into different segments of the spine. The screws act as anchors that are then connected by uniform metallic rods, which immobilize the spinal segments and facilitate fusion. These systems are not supposed to allow motion.

Agency officials said they are not currently recommending any changes regarding the use of dynamic stabilization systems.

Wright Medical Moving Operations to Holland

Wright Medical Group Inc. is moving its distribution and support facilities from France to its European headquarters in Amsterdam.

The move from Créteil, France, to Holland is expected to cost the company up to $5 million, including severance and benefits costs to employees displaced by the move. Wright plans to close its facility in France by the end of the year.

Officials at the company’s headquarters in Arlington, Tenn., did not know the number of French employees affected by the move.

Word of the move came just one month after Wright announced the creation of a new subsidiary, Wright Medical Australia Pty LTD. The new division will directly manage all of the company’s extremity and biologics distribution for customers in Australia and New Zealand.

In an October release, the company noted that the creation of Wright Medical Australia is a pivotal move that will facilitate the company's long-term objective of launching a portfolio of products to address the needs of specific customer segments in that region. The development also aligns with Wright's strategic vision of achieving focused selling through specialized distribution channels.

“Wright is pleased to add the Wright Medical Australia entity to our global family of subsidiaries,” said Karen L. Harris, Wright’s senior vice president of international. “The new subsidiary will provide Wright with enhanced control over distribution activities, as well as the leadership of a highly experienced and focused team of professionals with specialized knowledge in the extremity field and successful histories in the Australian market.”

Caragh Precision Launches Innovation Center

The Innovation Center at Caragh Precision is certainly living up toits name.

Recently launched by the Galway, Ireland-based firm, the center works with medical device companies

to bring new products to market. It helps customers through each stage of the product development process, providing such services as injection molding, product testing (functional and biological), and packaging.

“We have always seen the value in working with companies from an early stage, seeking to bring new products to market as efficiently as possible,” said Richard Gribbons, innovation and commercial director at Caragh. “We have a team of design engineers with extensive knowledge in medical device design and manufacturing. Our aim is to provide a turnkey solution to medical device companies, working with them as an outsourced partner from product and equipment design to prototyping and volume manufacturing.”

The center is housed within a 40,000-square-foot facility in Parkmore Business Park, a 38-acre chunk of land off the Galway ring road at Parkmore. Gribbons said the center helped Caragh develop a “suite of subcutaneous titanium ports” for a medical device firm and orthopedic products for a surgeon.

Caragh provides machining and finishing capabilities for the manufacture of orthopedic instruments and implants for the hip, knee, trauma, and extremities. Instruments developed by the firm include alignment jigs and cutting blocks, trials (metal and plastic), cup introducers, slap hammers, extraction devices, bone distractors and compressors, and retraction devices. It also develops bone screws, pedicle screws, extension pieces, hooks and axle pins.