Medtronic Announces Launch of ARTISAN[TM] Space Maintenance System.
MEMPHIS, Tenn. -- Medtronic, Inc. (NYSE:MDT) announced today the U.S. launch of its ARTISAN([TM]) Space Maintenance System. The device is cleared for temporary use in oral-maxillofacial surgical reconstruction and dental regeneration procedures to maintain space during bone graft procedures and to support soft tissue until bone formation occurs.
The TSRH(R) Spinal System is the second posterior fixation system by Medtronic to receive 510(k) clearance for the treatment of adolescent idiopathic scoliosis (AIS) with pedicle screws. (Photo: Medtronic, Inc.)
The announcement was made during the 93rd annual American Association of Oral and Maxillofacial Surgeons meeting in Philadelphia.
"The ARTISAN([TM]) Space Maintenance System has an overall advanced screw design that provides a low profile and a good interface between the screw driver and the screw head so a surgeon can place the screws with excellent visualization and accuracy. The system is matched to the characteristics of the facial bone for good retention," said Dr. Daniel Spagnoli1, DDS, MS, PhD, with the University of Oral and Maxillofacial Surgery in Charlotte, N.C., and assistant professor of oral-maxillofacial surgery at Louisiana State University School of Dentistry. "There are a number of titanium mesh products on the market, but the ARTISAN[TM] titanium mesh was designed specifically for the containment of bone grafts and has handling characteristics that make it easy for the surgeon to adapt it to the surgical site."
The ARTISAN([TM]) Space Maintenance System is composed of three primary space maintenance implants: porous titanium mesh and bone fixation screws; an umbrella-shaped screw, called a Tenting Screw, which protects bone grafts; and an implant called a Socket Preservation Screw. The Socket Preservation Screw implant is a potential breakthrough for cosmetic dentistry as it allows specialists the ability to preserve gum tissue architecture and anatomy while still protecting a bone graft. The Socket Preservation Screw allows for a simpler surgical approach by eliminating the need to perform a second flap to re-enter. A variety of instrumentation necessary for product implantation accompanies the system. All materials are housed in an easy-to-use tray and module set and can be assembled to meet customized orders.
"We are very excited about the prospects of ARTISAN([TM]) and believe this technology will both complement and enhance our current product offering in the dental and oral-maxillofacial space. Medtronic is quickly becoming a key player in this market, and we're enthusiastic about its future," said Brad Cannon, vice president, global commercial operations at Medtronic Spinal.
The ARTISAN[TM] system complements the other Medtronic products currently indicated and marketed in the dental and oral-maxillofacial market, and can be used with bone void fillers and extenders such as MasterGraft([R])ceramics and the PROGENIX([R]) DBM line of products. The ARTISAN[TM] system is not indicated for use with INFUSE[R] Bone Graft.
Bone Grafting and the Importance of Space Maintenance Today, bone grafting for oral-maxillofacial anatomy is a common occurrence. Often, grafting is required to correct bone loss caused by poor dental hygiene, neglect, trauma, and/or other co-morbidities. In the United States alone, a projected 1.4 million2bone grafting cases are expected in 2011. Specialists such as periodontists and oral surgeons utilize products, such as ARTISAN([TM]), to protect bone grafts and support soft tissue architecture in the mandible, maxilla, and other cranio-maxillofacial anatomy. Without proper space maintenance measures, soft tissue or other forces could collapse upon the graft site thereby disrupting the bone regeneration.
About the Spinal Business at Medtronic The 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. The Spinal business collaborates with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art products and technologies for neurological, orthopaedic, dental and spinal conditions. Medtronic is committed to developing affordable, minimally invasive procedures that provide lifestyle friendly surgical therapies. More information about the business and its therapies can be found at www.medtronicspinal.com and its patient-education Web sites, www.back.com, www.iscoliosis.com, www.maturespine.com and www.necksurgery.com, www.infusebonegraft.com.
About Medtronic Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
1 - Dr. Spagnoli is a consultant for Medtronic and receives royalties on the ARTISAN[TM] SPACE MAINTENANCE SYSTEM.
2 - Derived from the US Markets for Dental BioMaterials, 2010. Millennium Research Group.
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|Date:||Sep 12, 2011|
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