VertiFlex Introduces The First Ever Percutaneous Dual Rod Accepting Polyaxial Screw

Main Category: Neurology / Neuroscience
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices
Article Date: 14 Mar 2008 - 1:00 PDT

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VertiFlex Inc., a privately-held medical device company specializing in minimally invasive and motion preservation technologies for treating disorders of the spine, announced that it has received FDA 510K clearance for the Silverbolt™ Percutaneous Multi-Level Rod (MLR) System. The Silverbolt MLR System is the first ever system designed to percutaneously deliver two rods into a single screw for multi-level spine stabilization applications.

Utilizing the Silverbolt MIS Delivery System, the MLR System stabilizes multiple vertebral levels of the spine percutaneously, thereby offering patients an alternative to traditional, more invasive approaches. With benefits including less scarring, less blood loss, and quicker recovery times, this unique System is likely to become the preferred option for both patients and surgeons.

How it works. First, two independently acting rods are delivered into one central polyaxial screw. The first rod is reduced down into one of two adjacent polyaxial heads and secured. The second rod is then reduced down the same screw into the remaining adjacent polyaxial head and secured. Each screw is therefore capable of accepting two rods, which allows for multiple levels of fusion. The screw design also permits more angulation than other screw designs. Notably, the dual-rod configuration of the MLR System tested stronger than traditional single-rod fusion systems.

Dr. Adam Lewis at St. Dominic's Hospital in Jackson, Mississippi was the first surgeon to implant the Silverbolt MLR System on Monday, February 25, 2008. Lumbar levels L4, L5, and S1 were stabilized bilaterally using this system. The time to implant the Silverbolt MLR System was comparatively short at only 45 minutes. Dr. Lewis stated "The Silverbolt MLR offers patients a great alternative to traditional lumbar fusion because the percutaneous approach causes less tissue disruption and enables patients to recover quicker. This patient went home the next day." He went on to say "The System works very well. In fact, it is easier to use than other percutaneous pedicle screw systems. The dual rod system has more flexibility when seating the rod into the pedicle screws. I highly recommend this system."

Moti Altarac, General Manager and V.P. of R&D for VertiFlex, stated: "This system is an exciting introduction to the market for VertiFlex. It's an innovative and advanced way of treating multiple levels percutaneously." Mr. Altarac also noted that the "The Silverbolt MLR complements our existing product line in order to offer surgeons a full range of MIS solutions."

The Silverbolt MLR is currently available on a limited release basis to those surgeons that are current users of our Silverbolt MIS Screw System.

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.

VertiFlex