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Zimmer Seeks Return To Market-Level Hip/Knee Growth In 2010

This article was originally published in The Gray Sheet

Executive Summary

Zimmer's hip and knee sales are lagging slightly behind its competitors, but the firm is aiming to accelerate growth this year as several new product lines gain traction in the U.S

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New Products In Brief

Stryker's iVAS kyphoplasty system: Firm's Interventional Spine business launches iVAS minimally invasive, vertebral augmentation system for use in treating vertebral compression fractures (VCFs), Stryker announces April 13. During vertebral augmentation, also known as balloon kyphoplasty, a balloon catheter creates a void in the collapsed vertebra into which bone cement is delivered, creating an internal cast that stabilizes the fracture and alleviates pain in about 90% of patients, Stryker says. According to the firm, about 700,000 VCFs occur per year. Stryker now offers balloon kyphoplasty and vertebroplasty solutions on the same portfolio of "mixer and delivery systems, bone cements and needles," the firm notes, "giving physicians the flexibility to customize their treatment approach based on the type of compression fracture and patient anatomy." One recent study, however, suggests vertebroplasty treatment of spine fractures may have no lasting benefit (1"The Gray Sheet" Aug. 10. 2009)

Regulatory News In Brief

Stryker resolves another warning letter: The firm has resolved the second of four warning letters received since 2007 related to quality issues, Stryker reported March 23. Following a 2009 re-inspection and further corrective actions, FDA determined the company had sufficiently addressed a November 2007 warning letter for quality system problems at its reconstructive implant manufacturing facility in Mahwah, N.J. No further formal corrective actions are required, Stryker said. Last fall, FDA lifted another of the warning letters, this one for quality system and compliance violations at the orthopedic device maker's biotech division (1"The Gray Sheet" Oct. 26, 2009). Stryker initiated a three-year, roughly $200 million compliance program overhaul in 2008 (2'The Gray Sheet" Feb. 2, 2009)

Stryker Will Rule Reprocessing Roost With $525 Mil. Ascent Acquisition

Stryker will become the largest medical device reprocessing company in the U.S. with its $525 million acquisition of Ascent Healthcare Solutions, announced Nov. 30

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