New Balloon Bolsters DePuy Synthes Spine Portfolio of Procedural Solutions for Vertebral Compression Fractures

DePuy Synthes Spine announced the launch of the new SYNFLATE Vertebral Balloon as part of its portfolio of procedural solutions for the treatment of painful vertebral compression fractures, internal breaks in spinal bones that commonly occur in people with osteoporosis. According to the American Association of Orthopedic Surgeons (AAOS), more than 700,000 people suffer these types of fractures each year.1

The announcement was made here at the North American Spine Society (NASS) 28th annual meeting, where DePuy Synthes Spine is the only company to feature multiple vertebral balloons and cavity creation instruments and vertebroplasty cements and needles, including the high viscosity Confidence Spinal Cement System and VERTECEMĀ® II Bone Cement.

The SYNFLATE Vertebral Balloon is semi-elastic with material stiffness that has been optimized to enhance the structural stability of the balloon during inflation, enabling controlled and predictable cavity creation. At maximum inflation volume, the SYNFLATE Vertebral Balloon is nearly double the strength of standard elastic balloons currently available on the market.2 The SYNFLATE Vertebral Balloon is available in several sizes (10, 15 and 20mm), is offered with mono or bilateral access* kits, multiple access trocars, and can be used with bone fillers including VERTECEM II and CONFIDENCE Cements.

"The SYNFLATE Vertebral Balloon offers a versatility not found in other vertebral body augmentation portfolios," said Max Reinhardt, Worldwide President, DePuy Synthes Spine." The access kits accommodate different physician preferences and surgical approaches, and the multiple balloon sizes enable selection based on specific patient anatomy."

Vertebral body balloon procedures are used to reduce pain and strengthen and restore the shape and height of collapsed vertebra.1 In the procedure, the balloon is inserted into the vertebra and inflated to attempt to restore normal bone height. The balloon is then removed and the space or cavity that was created by the inflation of the balloon is filled with special bone cement to strengthen and stabilize the bone.

"DePuy Synthes Spine has created a portfolio of procedural solutions for the treatment of vertebral compression fractures that enables physicians greater choice and flexibility to use whichever products and procedures they determine are best for an individual patient, because no two fractures are alike," added Reinhardt.

In addition to the SYNFLATE Vertebral Balloon, the DePuy Synthes Spine portfolio of vertebral body augmentation solutions include the Vertebral Body Balloon, the CONFIDENCE SPINAL CEMENT SYSTEM, which combines a unique highly viscous cement with a novel hydraulic delivery system for vertebroplasty and VERTECEM II Bone Cement, which provides up to 17 minutes of working time and 18cc of cement to allow for a multi-level approach.

If a vertebral compression fracture occurs, doctors recommend conservative treatments such as bed rest, medications and physical therapy. If those fail, vertebral body augmentation may be recommended to reduce pain and improve mobility.

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*Available only outside the U.S.
1; accessed September 2013
2 Bench test results are not necessarily indicative of clinical performance. Comparative data on file at DePuy Synthes Spine.