Small Bone Innovations, Inc. (SBi, www.totalsmallbone.com), a leading provider of products, technology and education for the small bone and joint (SB&J) segment of the orthopaedics industry, announced that it has received the European Union (EU) CE Mark (Conformité Européene) for its PRECISE SD Distal Volar Radius Plating System for a wide range of wrist trauma repair and reconstruction procedures.
Anthony G. Viscogliosi, Chairman & CEO of SBi, said: “Fracture of the distal radius is the most pervasive injury requiring treatment by hand surgeons. In 2008, we estimate that there are approximately 350,000 surgical candidates in the world which equates to a market potential of over $500 million.”
The PRECISE SD system was developed by SBi with the help of leading surgeons and launched in April 2008. The declaration of the CE Mark now makes it available to surgeons throughout the EU.
The PRECISE SD plate geometry is based on computer analysis of CT (Computer Tomography) data generated from a broad series of distal radii in the Hamann-Todd Osteological Collection at the Cleveland Museum of Natural History. The result is a locking plate that provides a more optimal anatomical fit and improved articular support in wrist fractures. The plate’s polyaxial locking screw technology, licensed from Dr. Wolter, offers an unusually low profile design with a proven clinical track record in treating complex fractures, such as those associated with osteoporosis.
“In the course of developing a wrist treatment algorithm, surgeons told us they needed a fixation system able to achieve a lower profile and more precise fit where the degree of bone fragmentation is unusually complex such as in the estimated 250,000 older patients with symptoms of osteoporosis who fall and suffer a fractured wrist each year,” Mr. Viscogliosi added.
The advanced locking technology used in the PRECISE SD Plate allows a surgeon to insert polyaxial locking or non-locking screws and pegs at variable angles of +/- 15 degrees to the plate to address the location and geometry of a fracture or osteotomy. The Type II surface coating on plates and screws increases strength, reduces the risk of cold welding between the plate and screws, and avoids tissue adhesion.
Jesse B. Jupiter, MD*, Orthopaedic Hand Service, Massachusetts General Hospital, Boston, MA noted that: “Technological advances in three-dimensional imaging present a more precise picture of wrist fractures and that has led inevitably to demand for screw and plating systems capable of providing a correspondingly precise fit – as is the case with the PRECISE SD design.”
“Because the screws and pegs are slightly harder than the plates, the thread in the locking screw reshapes the softer titanium of the PRECISE SD plate, creating a secure construct between the head of the screw and the plate,” Dr. Jupiter added.
The introduction of the PRECISE SD system extends SBi’s wrist management portfolio following its rollout of the RE-MOTION™ Total Wrist Implant and STABILITY Sigmoid Notch Total DRUJ System™ – incorporating Precise Guidance Technology™ that assists surgeons with anatomical placement in wrist arthroplasty and reconstruction procedures.
SBi President, Thomas A. Crowley, noted that: “The availability of these completely modular systems enables surgeons to manage the varying degrees of severity in wrist injuries. This product’s versatility allows a surgeon to effectively treat and reduce multiple types of wrist fractures of various degrees of severity, quickly and easily. Precise SD allows SBi the opportunity to enter new markets and generate new sources of revenue in the SB&J sector.”
* Dr. Jupiter has consulted for SBi on surgeon education.
Source: Small Bone Innovations, Inc.