NEW YORK, Jan. 8, 2007 (PRIME NEWSWIRE) -- Small Bone Innovations, Inc. (SBi), a single-source provider of products, technology and education to small bone and joint orthopedic surgeons, announced an initial round of procedures using its new UNI-Elbow(tm) Radio Capitellum System (UNI-Elbow). The system incorporates SBi's Precise Guidance Technology(tm) (PGT) template and instrumentation.
Dr. Bernard Morrey, who co-designed the uni-compartmental implant under an agreement between SBi and the Mayo Clinic, in Rochester, Minn., began the first, post-launch use of the system in November, and in December, Dr. Itzhak Schwarzbard, a Long Island, N.Y., surgeon, used the UNI-Elbow device to correct an arthritic deformity and alleviate persistent joint pain.
The UNI-Elbow, designed primarily for use in association with SBi's rHead(tm) radial head prosthesis, is the first uni-compartmental elbow implant to become commercially available in the United States. The implant has 510(k) clearance from the U.S. FDA and is indicated for treatment of arthritic and traumatic conditions of the radio-capitellum joint.
The implant replaces the radio capitellum joint and preserves a normal, healthy ulno-humeral joint and, when implanted using PGT, is tissue-sparing and less invasive than performing a total elbow replacement. The PGT Axis Locator Clamp, a unique technology which positions around the radio capitellum joint and determines the anatomic center of rotation of the capitellum, is a critical element in ensuring precise implantation.
"There are some instances in which the stability and integrity of the radio-humeral articulation are essential, yet, the pathology requires reconstruction of both the proximal radius and the distal humerus," Dr. Morrey noted. "Under these circumstances, the prosthetic replacement, such as that offered in the Uni-Elbow design, seems to be the only viable option to adequately address the problem. The overall concept and the soundness of the procedure itself have prompted me to schedule several more surgeries and we look forward to monitoring results."
The UNI-Elbow System is based upon two reciprocating implant components, the Radio Capitellum implant and rHead(tm) radial head replacement implant system. The Capitellum Implant is made of cobalt chrome and possesses a highly polished articulating surface. The stem of the implant is plasma sprayed with commercially pure titanium and is anatomically designed for minimal bone resection in order to restore normal motion. The Capitellum Implant is available in Left and Right configurations, and Small and Large sizes. The radial head is available in standard and bi-polar configurations. The rHead stem possesses a 12 degree-curved stem to match the canal of the radius and can be press fitted or cemented.
At Brookhaven Hospital, Long Island, Dr. Schwarzbard reported that his first patient, a 71 year-old female, had her left radial head removed 12 years ago after a severe fracture from a fall. She presented sustained elbow pain and occasional wrist pain. Imaging revealed extensive capitellum arthritis and a 2.5mm ulnar positive wrist. This is a painful and debilitating condition that results when the distal end of the ulna migrates into the first row of carpal bones.
"I felt this was an ideal case for a UNI-Elbow construct as solely implanting a radial head would be unlikely to correct either of her debilitating conditions,". Dr Schwarzbard reported. "We are unaware of any option, other than a prosthetic replacement, for this difficult reconstructive problem," Dr. Schwarzbard said.
The smallest size Capitellum Stem was cemented into the humerus and a Size 2 Radial Stem was cemented into the radius with a Size 2 Standard Head.
"The result was a stable Radio Capitellum joint able to maintain a satisfactory range of motion and correction of the ulnar deviation in the wrist," he added.
Anthony G. Viscogliosi, Chairman and CEO of SBi, said, "The introduction of the UNI-Elbow as an integrated system fulfills a long-standing demand from surgeons that we alone could offer, due to our unique focus on small bone and joint surgery. I consider these early indications of success an endorsement of our continuing commitment to serve unmet needs in this sector of the orthopedic market."
About Small Bone Innovations, Inc.
Small Bone Innovations, Inc. (SBi) was founded in 2004 by Viscogliosi Bros., LLC, (VB), the New York-based merchant banking firm that specializes in the musculoskeletal /orthopedic sector. VB created SBi as the first company to focus purely on small bone and joint science. By integrating established companies and professionals in the field, SBi today offers a broad, clinically proven portfolio of products and technologies to treat trauma and diseases in small bones and joints.
In establishing SBi, VB acquired several prominent U.S., Canadian and European orthopedic device companies and product technology licenses focused on small bone and joint treatment, including arthroplasty, internal and external fixation, trauma, and biologics.
SBi completed a Series B financing, raising a record total of $42.2 million, announced in January 2006. Based on data provided by Venture Source, this was the largest venture capital investment ever recorded in the field of orthopedic devices.
SBi was a 2006 recipient of Red Herring magazine's annual "Red Herring 100 North America" award, recognized as one of the nation's leading technology companies and the only orthopedic device company selected among an initial entry of more than one thousand firms. Additionally, SBi's Artelon CMC-I Spacer, developed for patients with thumb base osteoarthritis, was featured on the cover and highlighted within Medical Design Technology magazine's "Year of Innovation" issue as one of the most fascinating technologies influencing the medical device industry.
The Small Bone Innovations, Inc. logo is available at http://www.primezone.com/newsroom/prs/?pkgid=3091
About Viscogliosi Bros., LLC
Established by Marc R. Viscogliosi, John J. Viscogliosi and Anthony G. Viscogliosi in New York City in 1999, Viscogliosi Bros., LLC (VB) was the first venture capital/private equity and merchant banking firm dedicated to the musculoskeletal/orthopedics sector of the health care industry.
Today, VB is a leading independent firm with a mission to create, build and finance companies founded on innovations developed by surgeons and uniquely focused on "life changing" musculoskeletal/orthopedic technologies. VB has worldwide surgeon, industry and trade relationships and significant financial expertise in the musculoskeletal/orthopedic sector.
As principals of VB, the Viscogliosi brothers have a combined total of nearly half a century of experience analyzing and investing in the musculoskeletal/orthopedics sector, directing literally billions of dollars through the orthopedics industry. They have pioneered innovative financial, strategic and management initiatives for nearly 150 companies in the sector, from start-up, seed and development stage all the way to exit, while helping thousands of people lead better lives through the orthopedic and spinal products marketed and sold by the companies they have assisted in developing and financing.
For more information about VB, please visit: www.vbllc.com