West Chester, PA – January 15, 2018 – 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 Monaco Pedicle Screw System. The system, that is based on a low profile screw head design, is used to stabilize the spine during non-cervical pedicle fixation and targeted to correct deformities of the lumbar spine.
The Monaco Pedicle Screw System provides the market with a low profile screw head, manufactured from Cobalt Chrome, that accommodates Ø5.5 & Ø6.0mm Cobalt Chrome and Titanium Alloy Rods. The unique design of the thread yields minimal to no wear debris during rod reduction and final tightening. The screw head and Locking Cap thread design deters splay along with the Cobalt Chrome material stiffness. This combination has proven that Monaco splays less than other similar and larger screw heads currently on the market. The bone screw thread design combines a single to dual lead thread design with a dual core diameter optimizing thread purchase with superior thread purchase. Straight and curved Cross Links are also available in range of sizes and can be easily assembled via a top-down technique. The implants are paired with a streamlined set of instruments designed to provide intra-operative flexibility.
The Monaco Pedicle Screw System includes: Pedicle Screws (Ø4.5-Ø9.5mm; 30-120mm lengths), Straight and Curved Cobalt Chrome and Titanium Alloy Rods, Straight and Curved X-Connectors, and Locking Caps, along with the required instrumentation to implant. The screw head maintains position which eliminates fiddle factor during surgery by allowing the rods to be easily implanted into the screw heads. Indicators are marked on the screw head and Locking Caps to identify the insertion position to eliminate cross threading and makes starting the Locking Caps easy.
First surgeries were completed atNYU Langone Orthopedic Center, by Dr. Anthony Petrizzo, DO and Dr. Aaron Buckland, MD. Dr. Petrizzo commented, “Screws are well designed with everything I need for straight forward degenerative and complex deformity cases.” He further added, “Ergonomically designed instrumentation with a wide array of tools to optimally secure the construct, the system will perform well in a variety of situations.”
Indications
The Monaco Pedicle Screw System is intended to provide immobilization and stabilization of spine segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
Altus Spine
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 510(k) 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.
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