Medtronic Receives Approval To Market Smaller Kit Sizes Of Infuse(R) Bone Graft

Main Category: Bones / Orthopedics
Also Included In: Regulatory Affairs / Drug Approvals;  Dentistry;  Medical Devices / Diagnostics
Article Date: 30 Apr 2008 - 4:00 PDT

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Medtronic, Inc. (NYSE: MDT) announced it has received approval to market two smaller kit sizes of INFUSE® Bone Graft for use in certain spinal fusion and dental regenerative procedures. The U.S. Food and Drug Administration (FDA) has approved two additional configurations of INFUSE Bone Graft: XX Small (0.7cc) kit and X Small (1.4cc) kit. These new sizes will be available for clinical use this June.

INFUSE® Bone Graft is recombinant human bone morphogenetic protein-2 (rhBMP-2) applied to an absorbable collagen sponge carrier. The purpose of the protein, which occurs naturally in the body, is to stimulate bone formation. It has been previously approved by the FDA for use in certain lumbar spine fusion and tibial fracture repair procedures and also certain oral maxillofacial and dental regenerative bone grafting procedures. Implanted into a bone-deficient site, INFUSE® Bone Graft works with the body's own biology to induce normal bone formation. INFUSE® Bone Graft offers surgeons and their patients an alternative to autogenous bone grafting; eliminating the need to surgically harvest bone from other parts of the patient such as the shin, hip or chin.

"Since its initial market introduction, INFUSE® Bone Graft has enabled advances in surgical procedures and been used successfully in treating over 500,000 patients," said Doug King, Vice President Sales, Medtronic's Spinal and Biologics business. "Expanding the portfolio increases the availability to a broader number of patients and represents Medtronic's continued commitment to innovation in the science of bone regeneration and advancing surgical technology."

Patients and physicians can learn more about INFUSE® Bone Graft at http://www.infusebonegraft.com.

About the Spinal Business at Medtronic

Medtronic's spinal business, based in Memphis, Tenn., is the global leader in today's spine market and is committed to advancing the treatment of spinal conditions. Medtronic's spinal business collaborates with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art products and technologies for neurological, orthopedic, oral maxillofacial and spinal conditions. Medtronic is committed to developing affordable, minimally invasive procedures that provide lifestyle friendly surgical therapies. More information about the company and its spinal treatments can be found at http://www.medtronicspinal.com and its patient-education Web sites, http://www.back.com, http://www.iscoliosis.com, http://www.maturespine.com and http://www.necksurgery.com.

About Medtronic

Medtronic, Inc., headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.

INFUSE® Bone Graft has not been tested in pregnant women to determine if it could pose harm to a developing fetus, nor has it been studied in nursing mothers. Women of childbearing potential should not be treated with INFUSE Bone Graft immediately prior to or during pregnancy, and should be advised not to become pregnant for one year following treatment. They should be warned of potential risks and should discuss other possible treatments with their doctor. For important safety information, please go to here.

INFUSE®BONE GRAFT in combination with LT-CAGE®, INTER FIX™ or INTER FIX™ RP Implants incorporate technology developed by Gary K. Michelson, M.D.

Medtronic, Inc.

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