KALAMAZOO, Mich., March 1 /PRNewswire/ -- Stryker Interventional Spine today announced the U.S. launch of VertaPlex® HV. VertaPlex HV is a high viscosity bone cement for use in treating vertebral compression fractures.
Vertebral compression fractures (VCFs) are a serious and growing problem for older Americans. An estimated 700,000 occur each year [1,2], often resulting in prolonged pain and disability [1,3,4]. Vertebroplasty and vertebral augmentation (also known as balloon kyphoplasty) are minimally invasive procedures widely used to treat the intense pain caused by VCFs. [5,6] They involve injecting bone cement into the vertebral body to create an internal cast that stabilizes the fracture, thereby reducing pain.
VertaPlex HV addresses several needs expressed by practitioner specialists regarding ease of use and individualized patient care. The cement achieves a thick viscosity as soon as it's mixed so there's no waiting time. It maintains this viscous state for an average of 18 minutes or longer, helping to satisfying the desire for immediate and longer working time. VertaPlex HV's thick viscosity helps contribute to a controlled fill that interdigitates with the trabecular bone.
"VertaPlex HV is the newest of three bone cements offered by Stryker to satisfy a variety of physician cement preferences," explains David Veino, Director of Sales and Marketing for Stryker Interventional Spine. "Independent test results by Fluid Dynamics, Inc., support HV's advantageous qualities of high viscosity and longer working time. We developed VertaPlex HV to provide physicians with the highest viscosity, longest working time and shortest mixing time of any of our cement offerings."
Other benefits of VertaPlex HV include a fast set time at simulated in-vivo temperature - approximately 10.2 minutes at 37 degrees Celsius, a lower creep rate to help reduce risk of leakage, and a 30 percent barium sulfate concentration to provide greater visibility in radiology images.
Limited release practitioner reactions to VertaPlex HV are overwhelmingly positive.
"VertaPlex HV is the ideal cement," says Dr. Mubin I. Syed, a neuroradiologist and interventional radiologist with Dayton Interventional Radiology in Dayton, Ohio, "It provides optimized mix, work and set times for our clinical needs."
As one of the world's leading manufacturers of bone cements, Stryker continues to set the industry standard in providing physicians with a range of bone repair cements that address their viscosity and working time preferences for percutaneous vertebroplasty and vertebral augmentation. This expertise is grounded in Stryker's Simplex® P Bone Cement. In 1971, Simplex P became the first surgical bone cement approved by the FDA for total hip replacement. For more than 40 years, tens of thousands of physicians have trusted Stryker bone cements derived from Simplex P including SpinePlex®, VertaPlex® and now VertaPlex HV.
Stryker Corporation is one of the world's leading medical technology companies with the most broadly based range of products in orthopaedics and a significant presence in other medical specialties. Stryker works with respected medical professionals to help people lead more active and more satisfying lives. Our Interventional Spine business manufactures minimally invasive solutions for relieving chronic back pain. Developed with respected medical professionals, Stryker offers a wide range of innovative products for spinal procedures and pain management treatments that reduce patient pain, shorten recovery time and improve quality of life. For more information about our Interventional Spine business, please visit http://www.StrykerIVS.com.
1 Cooper G, Lin J. Nonoperative Treatment of Osteoporotic Compression Fractures. http://emedicine.medscape.com/article/325872-overview Accessed Oct 30, 2009.
2 Freedman BA, Potter BK, Nesti LJ, Giuliani JR, Hampton C, Kuklo T. Osteoporosis and Vertebral Compression Fractures – Continued Missed Opportunities. The Spine Journal. Sept. 2008; Vol. 8, Issue 5: 756-762.
3 Sherman AL and Razack N. Lumbar Compression Fracture. http://emedicine.medscape.com/article/309615-overview Accessed Oct 30, 2009.
4 Old, JL and Calvert, M. Vertebral Compression Fractures in the Elderly. Am Fam Physician 2004;69:111-6.
5 Cloft HJ and Jensen ME. Kyphoplasty: An Assessment of a New Technology. AJNR Am. J. Neuroradiol., Feb 2007; 28: 200 - 203.
6 1. Kochan, J. Vertebroplasty and Kyphoplasty, Percutaneous. http://emedicine.medscape.com/article/423209-overview Accessed September 1, 2009.
Dr. Mubin Syed is a consultant with Stryker Interventional Spine and Boston Scientific Scimed, Inc., though he was not compensated for his comments reflected here.
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