VertiFlex Introduces A Revolutionary Solution For Minimally Invasive Spine Surgery - Silverbolt™ MIS Screw System

Main Category: Medical Devices / Diagnostics
Also Included In: Bones / Orthopaedics
Article Date: 24 Oct 2007 - 3:00 PDT

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VertiFlex Inc., a privately-held medical device company specializing in minimally invasive and motion preservation technologies for disorders of the spine, has announced the full commercial introduction of the Silverbolt™ MIS Screw System to the U.S. market. In early 2007, the company received FDA 510K clearance for the system, which will serve as a platform for percutaneous and mini-open fusion procedures.

Traditionally, lumbar fusion has been associated with highly invasive techniques or minimally invasive techniques that typically create difficult situations in which extensive operative time is needed. Thus, conventional techniques have not addressed what surgeons are asking for. Accordingly, Silverbolt's development was based on creating a system from the ground up as a percutaneous delivery platform. The system now allows surgeons and patients to benefit from smaller incisions as well as reduced operative times, blood loss and hospital stay. Along with supplying a surgeon with a percutaneous solution, the Silverbolt System also serves as a platform by supporting a mini-open approach through VertiFlex's unique Oracle Expandable Retractor and delivering VertiFlex's soon to be released dynamic stabilization products.

Dr. Dzung Dinh, Professor of Neurological Surgery at the University of Illinois College Of Medicine at Peoria, said, "Silverbolt finally addresses the concerns that spine surgeons have had with the current MIS systems. A simplified procedure, efficient system, and sleek design combined with the benefits of a percutaneous approach makes this system one of the most attractive in the marketplace."

Designed as a percutaneous geometric approach, the Silverbolt System was engineered to meet the concerns of surgeons. A pre-lordosed ball-end rod is delivered into the screw head in a convenient single step, while a draw bridge mechanism pushes the rod into the adjacent screw. No additional incisions are needed and the proprietary design ensures alignment even in the more difficult L5-S1 cases, while assuring accuracy of the rod delivery during a minimally invasive procedure. Silverbolt also allows for reduction of up to Grade 2 spondylolithesis percutaneously.

"The Silverbolt MIS Platform meets the original vision of the market with the ideal solution for single and multi-level percutaneous lumbar fusion," said CEO of VertiFlex, Keegan Harper. "Silverbolt's next generation technology solves some of the fundamental ease of use issues which now enable surgeons to consistently deliver MIS surgery to their patients in a safe, efficacious, and elegant method."

About VertiFlex

VertiFlex Inc. is headquartered in San Clemente California. Founded in 2005, the company is a venture-backed medical device company dedicated to the development and advancement of minimally invasive and motion preservation technologies for disorders of the spine. VertiFlex is committed to delivering advanced products that transform patient outcomes focusing on technologies that benefit both the surgeon and patient.

http://www.vertiflexspine.com.