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Zimmer Receives FDA Clearance for Revolutionary New Surgical Guidance Technology
iASSIST™ Knee Supports Streamlined, Personalized Knee Replacement Procedures
By: PR Newswire
Jan. 17, 2013 04:30 PM
WARSAW, Ind., Jan. 17, 2013 /PRNewswire/ -- Zimmer Holdings, Inc. (NYSE: ZMH; SIX: ZMH), a global leader in musculoskeletal health, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market iASSIST™ Knee, the Personalized Guidance System™ for knee replacement procedures.
iASSIST represents a revolutionary next step in surgical guidance, providing simple, intuitive and accurate intraoperative feedback and alignment validation to surgeons during joint replacement procedures, eliminating the need for bulky capital equipment. Current robotic and navigation systems use optical-tracking, requiring a clear line-of-sight into the surgical field, and rely upon complex additional equipment in the operating room, providing feedback on external computer screens.
Zimmer's iASSIST Knee technology comprises small electronic disposable pod components that are used at the site of knee replacement surgery, providing instantaneous, accurate alignment validation through a simple electronic display. The disposable pods are manipulated within the surgical field with positioning information provided by a series of internal accelerometers. iASSIST Knee does not require the use of pins or additional incisions and does not rely on external systems or stimulus.
"iASSIST Knee represents the next-step in intelligent instruments, offering significant benefits to patients, health care providers and health systems. This innovative technology supports more streamlined and personalized knee replacement procedures through a simple, disposable intraoperative device," said Jeff McCaulley, President, Zimmer Reconstructive. "We are greatly excited by the potential of iASSIST technology, which delivers on the promise of accurate implant positioning and alignment validation without the complexity, cost and time associated with current capital-intensive navigation and robotic systems."
iASSIST Knee technology is compatible with Zimmer's current and next generation knee systems.
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer designs, develops, manufactures and markets orthopaedic reconstructive, spinal and trauma devices, dental implants, and related surgical products. Zimmer has operations in more than 25 countries around the world and sells products in more than 100 countries. Zimmer's 2011 sales were approximately $4.5 billion. The Company is supported by the efforts of more than 8,500 employees worldwide. For more information, please visit our website at www.zimmer.com.
Zimmer Safe Harbor Statement
This press release contains forward-looking statements within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 based on current expectations, estimates, forecasts and projections about the orthopaedics industry, management's beliefs and assumptions made by management. Forward-looking statements may be identified by the use of forward-looking terms such as "may," "will," "expects," "believes," "anticipates," "plans," "estimates," "projects," "assumes," "guides," "targets," "forecasts," and "seeks" or the negative of such terms or other variations on such terms or comparable terminology. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that could cause actual outcomes and results to differ materially. For a list and description of such risks and uncertainties, see our periodic reports filed with the U.S. Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be set forth in our periodic reports. Readers of this document are cautioned not to place undue reliance on these forward-looking statements, since, while we believe the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this document.
SOURCE Zimmer Holdings, Inc.
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