SMALL BONE INNOVATIONS, INC. INTRODUCES ITS NEXT GENERATION RINGFIX™ CIRCULAR EXTERNAL FIXATION SYSTEM
NEW YORK NY, March 14, 2007 - Small Bone Innovations, Inc. (SBi), a single-source provider of innovation, products, technology and education for the small bone & joint sector of the orthopedic industry, has announced the introduction of its next generation RingFIX™ Circular Fixation System to treat diseases and trauma of the lower limbs. The introduction of the RingFIX™ system, a surgeon-innovated, patient-driven, indication-specific technology, launches SBi’s official “Year of the Lower Limb” campaign for 2007.
SBi’s RingFIX™ is a modular, circular, external fixation system designed to accommodate patients with a large variety of clinical foot & ankle needs. Originally marketed in Europe under the Fixano brand, RingFIX™ has a successful 18 year history of clinical use in the global healthcare marketplace. Developed around the principles of the Ilizarov technique and originating in Russia over 50 years ago, RingFIX™ offers near limitless external fixation configurations servicing both pediatric and adult patients with severe conditions of the foot and ankle.
The RingFIX™ system includes a broad selection of interchangeable components and ring geometries, and features Aluminum and Carbon Fiber Foot Plates. This large offering of rings in a variety of patient-pleasing colors, coupled with an assortment of struts, drill & bayonet tip wires, and now, new stainless steel Half Pins, makes RingFIX™ a powerful management system for treating an indication-specific, large patient population with lower limb-based clinical needs. SBi’s RingFIX™ system as well as the new Half Pins, are 510(k) cleared for marketing and use in the United States.
The new SBi RingFIX™ Half Pins are stainless steel, non-tapered, self-tapping pins, available in two diameters, multiple thread lengths, and multiple overall lengths. They are essential for complex procedures such as fusions, and are designed to be used in combination with the existing RingFIX™ wires. The new Half Pins will offer a considerably greater opportunity for RingFIX™ placement options and applications for indications such as severe trauma.
The SBI RingFIX™ Circular Fixation System is indication-specific, and particularly proficient for treating injuries about the foot and ankle. Focused applications for RingFIX™ include, but are not limited to: Charcot Disease reconstructions caused by Diabetes, Triple Arthrodesis, Ankle Fusion, Ankle Diastasis, Ankle Distraction and general trauma.
Nearly 21 million Americans – 7% of the US population – have diabetes, with approximately 1/3 of those unaware that they have the disease, according to the American Diabetes Association (ADA). The most common form of the disease, Type 2 diabetes, accounts for 90 to 95 percent of the cases. As many as 1 in 4 people with diabetes will develop a foot ulcer in their lifetime. These ulcers can become infected, cause disability, and potentially lead to amputation. More than 60% of non-traumatic lower limb amputations occur in people with diabetes – approximately 82,000 in 2002 alone Charcot foot occurs in diabetic patients from joint degeneration that causes the foot to collapse, widen and become deformed. Diabetic patients progressing to Charcot deformity have lost most of the sensation in the foot, are unable to feel pain, and lose the ability to sense the position of the ankle joint. Muscles fail to support the joint properly and the foot becomes unstable. SBi’s RingFIX™ Circular Fixation System stabilizes the Charcot foot and allows for proper alignment and recovery.
Patients in need of post traumatic reconstruction, congenital deformity correction, limb salvage or limb-lengthening have all been successfully treated by surgeons utilizing the SBi RingFIX™ system. According to Dr. Gary Jolly, recent past President of the American College of Foot and Ankle Surgeons (ACFAS), “SBi’s RingFIX™ system is based upon the time tested external fixation gold standard of Ilizarov’s method. Because the RingFIX™ system has been designed from the ground up to meet the specific requirements of lower limb surgeons, I find it far more user friendly in the Operating Room than other systems which have not been designed with this level of anatomic focus.”
Anthony G. Viscogliosi, Founder, Chairman & CEO of Small Bone Innovations, Inc., remarked on SBi’s RingFIX™ system, saying, “The SBi RingFIX™ Circular Fixation System highlights SBi’s innovative lower limb products, designed in union with – and specifically for – small bone & joint surgeons. The new addition of Half Pins to a technology with a long and successful clinical history, like the RingFIX™ system, will only add to its ability to address the diseases and injuries of the lower limbs and allow patients to live better lives.”
Viscogliosi added, “2006 was an extremely successful year for
SBi as we took major steps to remain the industry leader in the small
bone & joint market, specifically in the upper limbs – finger
to shoulder. The lower limbs – toe to below the knee – will
be our top priority for 2007 as we continue to strive to serve the unmet
clinical needs of small bone & joint surgeons and their patients.”
Viscogliosi Bros., LLC