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MINNEAPOLIS – August 25, 2009 – Medtronic, Inc. (NYSE:MDT) today announced financial results for its first quarter of fiscal year 2010, which ended July 31, 2009.

The company reported first quarter revenue of $3.933 billion, a 6 percent increase compared to the $3.706 billion reported in the first quarter of fiscal year 2009. Revenue growth on a constant currency basis was 10 percent after adjusting for a $145 million negative foreign currency translation.  This quarter contained 14 weeks, one more week than the first quarter of fiscal year 2009.

As reported, first quarter net earnings were $445 million, or $0.40 per diluted share, both decreasing 38 percent over the same period in the prior year.  As detailed in the attached table, adjusting for restructuring and certain litigation charges, and the impact of adopting a new accounting standard for non-cash interest expense on convertible debt, first quarter net earnings and diluted earnings per share on a non-GAAP basis were $883 million and $0.79, an increase of 9 percent and 10 percent, respectively, over the same period in the prior year.

“I am pleased with our solid first quarter performance and the progress it represents toward fulfilling our full year commitments,” said Bill Hawkins, Medtronic chairman and chief executive officer. “I am confident that our efforts to fuel innovation and develop a strong product pipeline positions us well for sustained growth during the remainder of the fiscal year and beyond.”

Revenue outside the United States of $1.542 billion grew 6 percent compared to the same period last year, or 16 percent on a constant currency basis, accounting for 39 percent of Medtronic’s worldwide revenue.

Spinal
Spinal revenue of $915 million grew 7 percent, or 8 percent after adjusting for an unfavorable $17 million foreign exchange impact. Sales of Core Spinal products, which includes Kyphon, increased 11 percent and Spinal revenue outside of the United States increased 24 percent, both on a constant currency basis. Biologics revenue remained flat when compared to the same period last year on a constant currency basis.

BOCA RATON, Fla.–(HSMN NewsFeed)–US Spine(R) is pleased to announce the commercial launch of the Preference 2 Complex Spine System(TM). The product has been in use at select sites throughout the spring and summer, with strong clinical feedback and results. The introduction of this product has improved the company’s pedicle screw business nearly 75% compared to last year at the same time.
The new system, which ushers the company into the complex spine market (estimated at more than $700 million), is a hook, rod and pedicle screw system with several implant options allowing multiple correction techniques and comprehensive instrumentation designed specifically to treat complex spinal pathologies. The system provides spine surgeons with a specialized solution to correct complex spinal pathologies such as scoliosis, kyphosis, trauma and tumors.

Advanced correction instrumentation, Cobalt Chrome Rods, Lateral Offset Connectors, Hooks, Rod-to-Rod Connectors and a Low-profile Cross Connector are among the many components that make up the system. All anchoring implants within the system feature the Helical Flange(R) Closure mechanism, which eliminates head splay and drastically reduces cross threading.

Leading spine surgeons with backgrounds in both pediatric and adult deformity developed the system with the goal of providing a low-profile, flexible and powerful offering that gives surgeons a no-compromise solution to treat complex spinal disorders.

“While we are primarily known as a developer of our Facet Fixation technology, we are very proud of our Preference 2 Complex Spine System and the impact it allows us to make within the Deformity, Tumor and Trauma market,” said US Spine’s Executive Vice President Paul Sendro. “The Preference 2 instrumentation has been designed from the ground-up with a full emphasis on complex spinal pathology. With specialized instrumentation, surgeons using the system are able to achieve greater precision and control.”

Source:   US Spine

BY LAUREN UZDIENSKI, AUGUST 13, 2009

FDA’s director of the Center for Devices and Radiological Health, Dr. Daniel Schultz, is resigning his post following a “mutual agreement” with FDA commissioner Margaret Hamburg.

The news follows complaints from critics that Schultz’s oversight of the device industry may have been too lax. One example is ReGen Biologics, where Schultz reportedly championed the company’s Menaflex device for market clearance despite the objections of certain FDA scientists. In May, the FDA announced that they would review the Menaflex clearance process.

In a statement, AdvaMed president and CEO Stephen Ubl praised Schultz for his contributions to the reauthorization of MDUFMA in 2007 as well as his role in the CDRH’s Postmarket Transformation Initiative, described by Ubl as “designed to improve the collection, analysis and utility of the agency’s multiple sources of postmarket medical device data.”

Schultz served as CDRH director since 2004 and worked at the FDA for 15 years. The agency’s associate commissioner, Jeff Shuren, will serve as acting CDRH director until Schultz’s replacement is named.

source: www.healthpointcapital.com

BOSTON–(HSMN NewsFeed)–Orthofix International N.V. (NASDAQ: OFIX ) announced today that Kevin L. Unger has been appointed as President of the Company’s spinal implants division. Mr. Unger will report directly to Brad Mason, who was previously named Group President of North America and has been serving as the President of Orthofix Spinal Implants since September of last year.

Mr. Unger joins Orthofix after more than 14 years with Stryker Corporation, where he served the last five years as a Vice President and General Manager in the MedSurg Division. While with Stryker Mr. Unger held roles with increasing responsibility in marketing and sales, during which he built sales organizations, was head of a global marketing department and led business development initiatives. He helped create a MedSurg business which grew from $30 million dollars to $200 million dollars under his leadership.

source:HSMN News feed