MEMPHIS, TENN. – September 12, 2011 – Medtronic, Inc. (NYSE:MDT) announced today the U.S. launch of its ARTISAN™ 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 announcement was made during the 93rd annual American Association of Oral and Maxillofacial Surgeons meeting in Philadelphia.
“The ARTISAN™ 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™ 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™ 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™ 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™ 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® ceramics and the PROGENIX® DBM line of products. The ARTISAN™ system is not indicated for use with INFUSE® 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 million2 bone grafting cases are expected in 2011. Specialists such as periodontists and oral surgeons utilize products, such as ARTISAN™, 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.