Valencia MIS 510(k) Clearance
West Chester, PA- April 28, 2017 – Altus Spine, a leader in the development and innovation of medical devices used in spinal correction surgery, announces the FDA clearance and market introduction of the Valencia MIS Pedicle Screw System. The Valencia MIS System, an extension of the popular Valencia Pedicle Screw System, is used to stabilize the spine during less invasive fusion procedures
The Valencia MIS Pedicle Screw System provides surgeons with a less invasive alternative to the standard pedicle screw systems allowing for smaller incisions to implant each device. Surgeons have more flexibility with screw placement and greater control rod insertion using 5.5mm bullet nosed rods. Powerful compression and distraction instruments are standard in the set.
“The Valencia MIS System gives surgeons and hospitals an advanced, less invasive option to care for patients,” says Michael Fitzgerald, President and CEO. “The system extends the capabilities of our popular Valencia Pedicle Screw System with a primary focus on improving patient care.”
The Valencia MIS System was developed using the proven foundation of the Valencia Pedicle Screw System which itself has a clinical history of success. “Surgeon input was critical to developing a simple, yet flexible, MIS stabilization system,” states Brian Bankoski, VP of Product Development. “Combining experienced surgeon input with the proven success of Valencia has made the system an extremely effective stabilization choice for MIS procedures.”
Valencia MIS System
The Valencia MIS Pedicle Screw System includes Pedicle Screws, Rod Connectors, and the instrumentation used in their implanting procedures. Valencia MIS screws are cannulated for use with guide wires for greater control of screw placement, and are available in a variety of lengths and diameters. Each screw is also equipped with removable tab extensions to assist in rod placement in minimally invasive procedures. Each implant is made of titanium for enhanced strength and durability.
Based in West Chester, PA, Altus Spine is dedicated to creating the next generation of medical devices. Altus strives to improve patient care by designing and manufacturing products to meet the highest standards in an ever changing and evolving field. Implemented and used by over 100 hospitals across the United States, Altus is among the fastest growing spinal implant companies in the world. For additional information, or to inquire about distribution opportunities, please visit www.Altus-Spine.com.
Forward Looking Statements
All statements made in the above press release, with the exception of historical fact, may be forward-looking statements that include risk, uncertainty, and assumptions. These factors could cause Altus Spine’s results to differ from those predicted if they do not occur as expected. These uncertain factors include, but are not limited to; acceptance and clearance of the company’s surgical products and procedures, development of new products and procedures, innovations and alterations to existing products and procedures, clinical and statistical verification of the success using Altus Spine’s products, company’s ability to maintain and monitor inventory as it releases new products, its ability to hire and retain personnel, and any other risks stated in prior or subsequent news releases. All risks and potential complications can be found in our most recent 510k report from the Food and Drug Administration (FDA). Given the constantly changing market, readers are encouraged to not place undue reliance on forward looking statements. Altus Spine assumes no obligation to update forward-looking statements as these changes occur, or as events and circumstances are altered, after the date they are posted.