Healthcare Industry News: MAYFIELD
News Release - August 31, 2009
Integra NeuroSciences Features New MAYFIELD(R) Infinity XR2 Radiolucent Cranial Stabilization System At World Congress of Neurological SurgeryPLAINSBORO, N.J., Aug. 31, 2009 -- (Healthcare Sales & Marketing Network) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART ) is featuring the MAYFIELD® Infinity XR2 Radiolucent Cranial Stabilization System at the XIV World Congress of Neurological Surgery in Boston, Massachusetts, August 30 - September 3, 2009. The MAYFIELD® Infinity XR2 Radiolucent Cranial Stabilization system provides rigid skeletal fixation of a patient's skull for use in neurosurgical procedures that utilize X-ray, Fluoroscopy, Digital Subtraction Angiography (DSA) or CT imaging modalities. The MAYFIELD® Infinity XR2 Skull Clamp has received 510(k) clearance from the United States Food and Drug Administration and CE Mark Certification in the European Union.
Many cerebrovascular procedures, such as aneurysm and arteriovenous malformation (AVM) repair, require fluoroscopy to visualize blood vessels in the bony environment of the skull. Fluoroscopy is also used in the precise placement of cervical spinal implants. Both types of procedures require rigid skeletal fixation. Metal cranial stabilization equipment can cause unwanted image artifacts that hinder the capabilities and usefulness of the fluoroscopy image. The new MAYFIELD® Infinity XR2 Radiolucent system allows neurosurgeons to perform fluoroscopy during neurosurgical procedures without compromising image quality. In addition, the new system has been specifically designed to meet the positioning challenges posed by the small size of the pediatric patient.
The MAYFIELD® Infinity XR2 Radiolucent Cranial Stabilization System consists of the XR2 Skull Clamp, along with the more robust XR2 Base Unit, and the XR2 Tri-Star Adaptor for use with image guided surgical systems. The MAYFIELD® Infinity XR2 Base Unit provides a wide imaging window and easy-to-assemble linkage; it is constructed with composite materials for improved rigidity, strength and durability, all while retaining a high versatility of product maneuverability for optimal patient positioning. The MAYFIELD® Infinity XR2 Skull Clamp includes both a 1/4 turn lock/unlock mechanism on the dual-pin side for easier application to the patient's head, and the unique ability to switch the dual-pin rocker arm from adult to pediatric, quickly and without tools.
"The new MAYFIELD® Infinity XR2 system brings a new level of stability and rigidity to the operating room, without compromising image quality. The system confirms Integra's dedication to innovation and our leadership position in cranial stabilization," said Chris Thatcher, President of Integra NeuroSciences.
These products reflect the continued innovations to the MAYFIELD® product line of cranial stabilization products started by world renowned neurosurgeon, Dr. Frank H. MAYFIELD, over 40 years ago. MAYFIELD® cranial stabilization systems are used worldwide in over 200,000 brain procedures annually. These procedures include treatment of head trauma injuries, pediatric disorders such as hydrocephalus, biopsies, cancer removal, cerebrovascular disorders such as aneurysms, and neurodegenerative disorders such as Parkinson's disease or epilepsy.
"The MAYFIELD® Infinity XR2 system provides our customers with the rigid platform required for delicate neurovascular surgery," stated Christopher von Jako, Vice President of Marketing for Integra NeuroSciences. "This latest advancement in our MAYFIELD® cranial stabilization portfolio reflects our commitment to deliver products and support that help our customers Operate with Confidence(TM)."
Integra currently offers a diverse line of MAYFIELD® cranial stabilization products, which are sold by the Integra NeuroSciences sales organization. Integra NeuroSciences is a leading provider of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neuro-trauma and related neurocritical care.
Integra LifeSciences Holdings Corporation, a world leader in regenerative medicine, is a global medical device company dedicated to improving the quality of life for millions of patients each year. The company's products are used primarily in orthopedics, neurosurgery and general surgery. Headquartered in Plainsboro, New Jersey, Integra has research and manufacturing facilities throughout the world. www.Integra-LS.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 future use of the MAYFIELD® Infinity XR2 Radiolucent products. 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 physicians to use these products may affect their prospects for its use in clinical 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, 2008 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.
Source: Integra LifeSciences
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