Small Bone Innovations Rolls Out Next Generation RingFIX System

New York - 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 rolled out its ‘next generation' model of its RingFIX Circular Fixation System to treat diseases and trauma of the lower limb such as Charcot foot. SBi also reported that it had received FDA market clearance to introduce a series of "FootFIX" forefoot fixation pins, staples and screws to expand its lower limb portfolio.

Anthony G. Viscogliosi, Chairman & CEO of SBi, said: "With RingFIX as the focal point of our drive toward total technology coverage in foot & ankle treatment, these next-generation, surgeon-innovated versions of clinically proven external fixation systems put SBi ahead of schedule in its goal to be the provider of choice in the small bone and joint sector."

The RingFIX system has been modified to accommodate a wider range of foot & ankle conditions than its predecessor. It was marketed previously in Europe under the Fixano brand (a French company acquired by SBi in 2005). The device had an 18 year history of successful clinical use using the principles of the Ilizarov technique for limb preservation and correction of deformity through reconstruction and restoring function using external fixation.

The current system, cleared for marketing by the FDA earlier this year, comprises 208 components including stainless steel half pins, rods, drill & bayonet tip wires, 53 light alloy rings and aluminum or carbon fiber foot plate options.

The dominating growth factor in lower limb disease is treatment of Charcot foot deformity and ulceration associated with diabetes. Other FDA-cleared indications include ankle fractures, limb lengthening and treating bone and joint deformities or defects.

Michael S. Pinzur, MD, Professor of Adult Orthopaedics & Rehabilitation - Foot & Ankle Surgery - at Loyola University Medical Center in Chicago, said: "There is a growing body of clinical evidence that the use of sophisticated external fixation technology such as the RingFIX circular fixation device represents a tissue sparing and function restoring alternative to amputation for diabetic patients."

More than 60% of non-traumatic lower limb amputations occur in people with diabetes – approximately 75,000 in 2003, according to the US Centers for Disease Control.

Mr. Viscogliosi noted that: "An even more distressing statistic is that 85 percent of amputations could be avoided through early intervention and diagnosis. Of all treatment methods offered by SBi and the industry generally, this is a huge opportunity to dramatically alter outcomes and, in essence, restore hope by saving both the form and function of the lower limb."

SBi's goal of establishing a comprehensive foot and ankle management system has been boosted further by recent FDA 510(k) clearances of forefoot repair components as a part of its "FootFIX" product line for bone reconstruction, osteotomy, arthrodesis and fracture repair.

The newly cleared products include: StaFIX threaded staples; PercuFIX threaded pins; and TwistoFIX compression screws in a complete forefoot fixation set. SBi anticipates more additions to its foot and ankle portfolio following the completion of several transactions during the past year involving licenses and technology acquisitions.

The StaFIX stainless steel threaded staple set is designed for repair of small bone fractures in the foot, osteotomy, fusions and soft tissue re-attachment. The set contains three sizes of staple in a straight and angulated configuration, while the straight soft tissue staple comes in four sizes. The threaded ends facilitate ease of removal.

The PercuFIX ‘break-away' percutaneous titanium alloy pins (in 5 lengths, 1.8 mm dia.) require no use of a wire cutter and are threaded for ease of removal. The TwistoFIX self-drilling/self-tapping screw set (in 5 sizes, 2mm dia.) with accompanying clamp enables the surgeon to determine precisely screw length and placement.

Anthony G. Viscogliosi, SBi's CEO, noted: "We are determined to offer the widest, deepest and most anatomically focused portfolio of products to cover the entire continuum of foot and ankle care and these new product launches are a major step in that direction."

SOURCE: Small Bone Innovations, Inc.