Osseoflex Article Header

Pathologic fractures of the vertebra, also referred to as vertebral compression fractures (VCFs), are the most common fracture in patients with osteoporosis and a common occurrence as a result of malignancy in patients with metastatic cancer. VCFs result in debilitating pain and can lead to a host of health-related issues with an associated reduction in quality of life and increased mortality.1,2 Traditional treatment of these fractures has included non-operative management consisting of bed rest, pain medication, and bracing. Minimally invasive procedures such as vertebroplasty and vertebral augmentation (also referred to as kyphoplasty), in which cement is delivered into the fractured vertebra, have been shown to be safe and effective in rapidly reducing pain, improving function, and ultimately reducing mortality.2-4

Balloon kyphoplasty, which involves inflation of a percutaneously delivered balloon within the fractured vertebrae followed by injection of cement, is currently the most commonly performed minimally invasive procedure for treatment of VCFs. It is routinely performed as a bilateral procedure in which a balloon is inserted into each side of the vertebra. When performed as a unilateral procedure, comparable pain relief, height restoration, and kyphotic angle restoration have been reported.5,6 Advantages of a unipedicular approach include shorter operative time and less radiation exposure to the operator.6 Considerations of which approach is used is multifactorial and based on patient condition, fracture morphology, and/or physician preference.

With the addition of the Osseoflex® SB Steerable and Straight Balloons family of inflatable bone tamps, Merit Medical expands its spine product offering to include balloon technology. In addition to conventional straight balloons, the Osseoflex SB product line includes steerable balloons which enable the physician to achieve unipedicular cavity creation in the anterior central portion of the vertebral body with a less severe approach angle through the pedicle. This should minimize potential for cement leakage in the canal that can occur when attempting to place straight balloons more medially and violating the medial cortex of the pedicle.7

To complement the steerable balloon, we are pleased to introduce the Osseoflex® SN Steerable Needle. This unique articulating design allows for targeted delivery of cement when used alone as well as in conjunction with Merit’s PowerCURVE® Navigating Osteotome and/or Osseoflex Steerable Balloons.

  1. Rostom, S., Allali, F., Bennani, L., et al. (2012). The prevalence of vertebral fractures and health-related quality of life in postmenopausal women. Rheumatol Int, Apr;32(4):971–980.
  2. Edidin, A. A., Ong, K. L., Lau, E., et al. (2011). Mortality risk for operated and nonoperated vertebral fracture patients in the medicare population. J Bone Miner Res, July;26(7):1617–1626.
  3. Barr, J. D., Jensen, M. E., Hirsch, J. A., et al. (2014). Position statement on percutaneous vertebral augmentation: A consensus statement developed by the Society of Interventional Radiology (SIR), American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS), American College of Radiology (ACR), American Society of Neuroradiology (ASNR), American Society of Spine Radiology (ASSR), Canadian Interventional Radiology Association (CIRA), and the Society of NeuroInterventional Surgery (SNIS). J Vasc Interv Radiol, Feb;25(2):171-181.
  4. Clark, W., Bird, P., Gonski, P., et al. (2016). Safety and efficacy of vertebroplasty for acute painful osteoporotic fractures (VAPOUR): A multicentre, randomised, double-blind, placebo-controlled trial. Lancet, Oct 1;388(10052):1408-1416.
  5. Yang, S., Chen, C., Wang, H., et al. (2017). A systematic review of unilateral versus bilateral percutaneous vertebroplasty/percutaneous kyphoplasty for osteoporotic vertebral compression fractures. Acta Orthop Traumatol Turc, Jul;51(4):290-297.
  6. Papanastassiou, I. D., Eleraky, M., Murtagh, R., et al. (2014). Comparison of unilateral versus bilateral kyphoplasty in multiple myeloma patients and the importance of preoperative planning. Asian Spine J, Jun;8(3):244-252.
  7. Chung, H. J., Chung, K. J., Yoon, H. S., et al. (2008). Comparative study of balloon kyphoplasty with unilateral versus bilateral approach in osteoporotic vertebral compression fractures. Int Orthop, Dec;32(6):817-820.