Musculoskeletal News Roundup 14-Apr-11
BY LAUREN UZDIENSKI, APRIL 14, 2011
Earnings
Biomet reported F3Q:11 sales of $678.0 million, up 2% over the year-ago period. Recon sales contributed $516.0 million and increased by 1% over the year-ago period, with hip sales flat, knee down 1%, extremity up by 18% and dental up by 6%. Trauma sales declined by 1%. Spine sales increased by 1%. All growth rates exclude the effects of currency. Adjusted net income for F3Q:11 was $63.8 million, which compares to $67.3 million in the year-ago period.
Funding
DGIMed Ortho raised $2.1 million in its latest funding round. The company manufactures the Distalock system of intramedullary nails and drills.
Regulatory
Covidien announced that its DuraSeal Exact spine sealant has been approved by the FDA. The company describes DuraSeal Exact as a new, low-swell, watertight formulation of dural sealant designed as an adjunct to suturing to repair the dura during spine surgery. The company first received FDA approval for DuraSeal in 2009.
Integra announced several 510(k) clearances this week, including a new indication for their Accell Evo3 Demineralized Bone Matrix. The product can now be marketed as a bone void filler in the posterolateral spine. An animal study of Accell Evo3 Demineralized Bone Matrix demonstrated effective bone formation and bilateral fusion at 12 weeks. Additionally, the FDA cleared three new spinal intervertebral body fusion devices, the Cervical Stand-alone IBD, Vu cPOD Non-Strut IBD and Steerable IBD. The fixation systems are currently in limited commercial release and are targeted for full commercial release later this year.
Medyssey Spine received 510(k) clearance for its LP Cage, which is indicated for use in skeletally-mature patients with degenerative disc disease at one or two contiguous levels from L2-S1. The system uses a posterior approach. The product is currently in limited, controlled release, with a full commercial launch expected by 4Q:11.
OrthAlign received 510(k) clearance for the next-generation KneeAlign system. According to the press release, the system "combines tibial and femoral knee replacement navigation in a single, disposable, palm-sized device." The company adds that the KneeAlign 2 "eliminates the need for an intramedullary rod by enabling the orthopedic surgeon to locate the center of the femoral head with a simple intraoperative maneuver."
Product Introduction and Update
Lanx launched two products at AANS this week: the Concero Facet Screw System, which the company calls a minimally invasive fixation alternative to pedicle screws for use at single or multiple levels from L1 to S1, and the Durango Stand-Alone ALIF System, which is intended for use at one or two levels from L2 to S1 and is a stand-alone implant when used with all four fixation screws. The company also announced that they have reached 17,000 implantations of their Aspen Spinous Process Fixation System.
Micromedics launched a 15cc Graft Delivery Device, the first product in their OsteoXpress line of bone grafting devices. These devices facilitate the mixing of bone graft material used in orthopedic procedures.
Orthovita launched the Aliquot Directional Bone Tamp, a channel creation device for the delivery of Cortoss Bone Augmentation Material into the vertebral body. The company says the new device "expands the procedural options for Cortoss in the [VCF] market."
Salient Surgical Technologies launched an expanded global medical education program designed to "[provide] cutting-edge training on advanced surgical techniques and technologies, including usage of Salient's TRANSCOLLATION technology," which provides hemostatic sealing of soft tissue and bone tissue at the operative site. Topics will include the direct anterior approach to hip replacement, knee arthroplasty procedures, including tourniquet-less approaches and minimally-invasive and deformity spine surgery techniques.
Spine Surgical Innovation launched the In-Situ Cobalt Chrome 3.2mm and 3.5mm Rod Cutters. The in-situ cutters eliminate the need for the traditional steps of measuring, removing, cutting and reinserting a rod.
Thompson MIS launched the BoneBac Press, a reusable device that enables surgeons to "more effectively utilize local autograft bone for fusion and reconstructive procedures."
Tornier launched the BioFiber Surgical Mesh for the repair of rotator cuff and other tendon and ligament injuries. The company says the fibers of the mesh are derived from a new class of proprietary resorbable polymers called polyhydroxyalkanoates (PHAs) developed by Tornier's corporate partner, Tepha Medical Devices. The mesh features a "three-dimensional structure designed to provide a strong, but flexible scaffold for cell migration and enhanced healing."
Intellectual Property
Microaire Surgical Instruments received patent number 7,918,784, covering an "endoscopic surgical tool with retractable blade for carpal tunnel release."
Reimbursement
Small Bone Innovations announced that Coventry Health Care will now cover the company's STAR Total Ankle Replacement system, reversing a prior policy. Coventry Health Care covers 1.7 million people nationwide. Additionally, BlueCross BlueShield of Arizona, which covers 1.3 million individuals in Arizona, also reversed a coverage decision and will now reimburse the STAR ankle. The company adds that "all 39 independent member companies of the BlueCross and BlueShield Association now cover SBi's STAR Total Ankle Replacement system."
Clinical
Bone Solutions completed a pilot study indicating that its OsteoCrete product "may be the first bone void filler to be successfully used" to facilitate fusion in a rabbit posterolateral lumbar spine model. OsteoCrete is magnesium-based and is both injectable and moldable, and the company says that the magnesium-based technology, along with other ingredients, "provides significant compressive strength and possesses Ph-neutral qualities" compared to traditional calcium-based bone void fillers. OsteoCrete is already FDA-cleared as a bone void filler, and the company plans to commence production in 4Q:11.
Cerapedics announced the results of a prospective, randomized, controlled trial of its i-FACTOR biologic bone graft for patients undergoing PLIF procedures. Data from 40 patients demonstrated superiority of i-FACTOR biologic bone graft over autologous bone, with a radiologic fusion rate of 98% for patients treated with i-FACTOR compared to 59% for patients treated with autograft at six months. At one year, i-FACTOR patients demonstrated a radiological fusion rate of 98%, which compares to 82% for patients treated with autograft. i-FACTOR consists of an anorganic bone mineral and a small peptide that "acts as an attachment factor for specific integrins on osteogenic cells." It is CE-marked and is currently being evaluated under an IDE in the U.S.
Orthovita announced the presentation of a study entitled "Prospective Randomized Evaluation of a Collagen/Thrombin and Autologous Platelet Hemostatic Agent During Total Knee Arthroplasty" at the Mid-America Orthopaedic Association in Tucson, Arizona last week. The 100-patient study found the use of standard hemostasis with Vitagel Surgical Hemostat was found to reduce blood transfusions following primary total knee arthroplasty when compared to standard hemostasis alone. Patients treated with Vitagel were also trending toward higher hemoglobin levels starting on the second postoperative day; this trend achieved significance by the fourth day.
Legal
Stryker sued Zimmer for violations of trade secrets and breach of contract, alleging that Zimmer "poached entire segments of Stryker's sales force."
Partnerships
Integra LifeSciences announced a partnership with InstruMedics LLC., whereby InstruMedics will provide a "comprehensive solution for managing the service and repair needs of surgical instruments, rigid endoscopes, flexible endoscopes and powered surgical equipment."
