A Medical Device Daily

Small Bone Innovations (SBi; New York), a provider of products, technology and education for the small bone and joint (SB&J) segment of the orthopedics industry, reported receipt of the CE mark for its Precise SD Distal Volar Radius Plating System for a wide range of wrist trauma repair and reconstruction procedures.

The Precise SD system was developed by SBi with the help of leading SB&J surgeons and launched last April. Receipt of the CE mark now makes it available to surgeons throughout the EU.

The company said the Precise SD plate geometry is based on computer analysis of CT (computed 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, it said, is a locking plate that provides "a more optimal anatomical fit and improved articular support in wrist fractures."

SBi said the plate's polyaxial locking screw technology offers "an unusually low-profile design with a proven clinical track record in treating complex fractures, such as those associated with osteoporosis."

Jesse Jupiter, MD, of the Orthopaedic Hand Service at Massachusetts General Hospital (Boston), noted that: "Technological advances in 3-D 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."

Jupiter added, "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."

SBi Chairman/CEO Anthony Viscogliosi 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."

He added, "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."

The 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 company added that 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."

The introduction of the Precise 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 the company's Precise Guidance Technology.

Kiva System earns CE mark

Benvenue Medical (Santa Clara, California), a developer of minimally invasive solutions for spine repair, said it has received CE-mark approval in Europe for its Kiva Vertebral Compression Fracture (VCF) Treatment System.

The company said initial clinical cases in Europe using the Kiva System have been successfully performed and added that it is preparing for the commercial launch of the product throughout the region.

"The CE mark is an important milestone for the company because it allows us to commercialize the Kiva System in some of the largest and fastest-growing VCF markets in the world, and further validate the benefits delivered by the system through expanded clinical use," said President/CEO Laurent Schaller.

Benvenue said the Kiva System "addresses unmet needs of spine physicians who treat painful VCFs due to osteoporosis, trauma, and cancer." The system incorporates the company's flexible spinal implant technology.

The implant, which is manufactured from PEEK, is introduced using a percutaneous, over-the-wire technique. It reduces and stabilizes the fracture and is designed to provide containment during delivery of PMMA bone cement.

Over more than one year of clinical use, the Kiva System has provided VCF patients with what Benvenue described as "immediate pain relief and consistent functional improvement, while requiring significantly less bone cement than is customarily used in kyphoplasty and vertebroplasty procedures."

The first clinical cases in Europe using the Kiva System were performed recently by Stephan Becker, MD, at the Orthopedic Hospital Speising (Vienna, Austria). "Among all of the new approaches to VCF repair that I have seen, the Kiva System offers a new unipedicular method to improve the treatment of these painful fractures. The system deploys an implant that can restore height and provide a safe containment for low-viscosity cement."

The company said VCF treatment represented a global market of roughly $600 million and more than 200,000 procedures in 2008. It said the market remains "underpenetrated," with roughly 700,000 additional VCF patients diagnosed each year worldwide.

Benvenue said the fast-growing European VCF market currently represents about 25% of the global market.

New terahertz technology reported

A new biochip technology based on terahertz spectroscopy allows the detection of DNA without fluorescent markers. Precise assays with sensitivity in the femtomolar range can be carried out and evaluated in a short period of time.

The inventor of the procedure, Professor Haring Bolivar of the Institute of High Frequency and Quantum Electronics at the University of Siegen (Siegen, Germany), will talk about the technology behind the DNA detection method at a conference for Terahertz Systems and Industrial Applications in London on Wednesday in a presentation on "Small Scale Terahertz Lab-on-a-chip."

The DNA detector enables the accurate distinction between single- and double-stranded DNA molecules, the identification of their presence and the detection of gene mutations.

Bolivar said this new procedure represents a "substantial improvement" in the detection of genes with the help of so-called gene chips, for the detection of genetic diseases in humans.

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