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NEW PRODUCTS / PRODUCT NEWS
Intramedullary Fusion Device
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Extremity Medical, LLC, has received FDA (Food & Drug Administration) approval for their Hallu·X Intramedullary Fusion Device. Hallu·X is an intramedullary device for the first metatarsophalangeal joint that represents a significant advance in small bone technology.
The Hallu·X implant delivers compression across the targeted joint, which increases stability compared with plates and screws while maintaining a low profile. Hardware-related complications caused by plates and screws are common in this and many similar applications. Extremity Medical notes that the design of the Hallu·X device eliminates the need to bend plates and allows variable positioning of the phalanx to accommodate different patient needs. The Hallu·X Intramedullary Fusion Device also comes with advanced instrumentation that can reduce operative time and allow for easy removal of the device.
To learn more, contact
Extremity Medical
300 Interpace Parkway, Suite 410
Parsippany, NJ 07054
phone (973) 588-8980
fax (973) 316-9901
www.extremitymedical.com |
New Patient Web Site
| A new Web site designed to help thousands of patients with broken bones has been launched by Smith & Nephew.
The new site, www.exogen.com, provides information about broken bones and the healing process, including tips from healthcare professionals on how patients may be able to aid recovery.
The Web site also explains risk factors that can delay bone healing, such as smoking, diabetes, and obesity. Some broken bones may be less likely to heal because of their location—the clavicle, scaphoid, tibia, and fifth metatarsal.
For patients prescribed the Smith & Nephew EXOGEN™ Ultrasound Bone Healing System to aid their recovery, www.exogen.com explains how the clinically proven technology works.
To learn more, contact
Smith & Nephew Inc.
4721 Emperor Boulevard
Durham, NC 27703
phone (919) 474-6670
www.exogen.com |
All-In-One
Delivery System
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US Spine® has launched the Facet Gun™ MAX, the latest evolution of its patented Facet Fixation platform. The Facet Gun MAX offers improved performance and consistency while maintaining core features such as strength, speed and ease of use. The Facet Gun MAX consists of a reusable hand piece with quick-release, disposable implant cartridges.
The company notes that the new Facet Gun MAX enables spine surgeons to lock the facet joint in 2 simple steps via an easy-to-use gun-shaped “all-in-one” delivery system. US Spine’s Facet Bolt provides stiffness and strength equivalent to conventional stabilization and fusion devices but is simpler and faster to use and less invasive. The system is designed to lock a spinal motion segment at risk of instability following laminectomy.
US Spine points out that the Facet Gun’s simple, intuitive design allows a surgeon to lock a spinal motion segment in just minutes rather than the hours required from traditional stabilization methods.
To learn more, contact
US Spine
600 FAU Boulevard, Suite 101
Boca Raton, FL 33431
phone 561) 36.SPINE
fax (561) 367-9627
www.us-spine.com |
Cement Delivery System
| Medtronic, Inc., announced the full US launch of the KYPHON Cement Delivery System, adding an innovative bone cement delivery option to its extensive KYPHON Balloon Kyphoplasty product portfolio for the treatment of vertebral compression fractures (VCFs).
The KYPHON Cement Delivery System allows physicians to keep a farther distance from the radiation source during the cement delivery phase than with Medtronic’s current delivery system used in the balloon kyphoplasty procedure. It allows for the delivery of KYPHON HV-R® Bone Cement with one-handed operation, preserving some tactile feel during delivery with the ability to halt bone cement flow on demand with the quick-release button.
To learn more, contact
Medtronic
710 Medtronic Parkway
Minneapolis, MN 55432-5604
phone (800) 633-8766
fax (763) 514-4879
www.medtronic.com |
Shape Memory PEEK Device
MedShape Solutions, Inc., announced the first FDA-cleared shape memory PEEK (polyaryletheretherketone) device for orthopedics using PEEK Altera™ material. PEEK provides excellent benefits such as strength, radiolucency, and reliability.
The Morphix™ Suture Anchor was recently granted FDA clearance and will be released to select US markets in the coming months. The Morphix Suture Anchor system design takes advantage of the shape memory material and provides superior fixation strength both in pullout as well as improved performance under cyclic loading.
To learn more, contact
MedShape Solutions
1575 Northside Drive, Suite 440
Atlanta, GA 30318
phone (404) 249-9155
fax (404) 249-9158
www.medshapesolutions.com |
Ankle Fusion Nail System
Wright Medical Group, Inc., announced the limited release of the VALOR™ Ankle Fusion Nail. The VALOR™ Ankle Fusion Nail system consists of multiple implant sizes, lengths, and configurations that ensure an accurate fit based on patients’ needs. Wright Medical notes that each fusion nail implant incorporates an innovative compression device that allows surgeons to control the compression between the bone surfaces. This enhanced compression feature is designed to maximize the likelihood of a solid fusion, thereby alleviating pain.
The company notes that the VALOR™ Ankle Fusion Nail combines traditional intramedullary fixation techniques with a novel internal compression technology, efficient and stable instrumentation, and a secure fixed angled construct.
For more information, contact
Wright Medical Group
5677 Airline Road
Arlington, TN 38002
phone (800) 238-7117
fax (901) 867-9534
www.wmt.com |
Anatomic Cruciate Reconstruction System
CONMED Linvatec arthroscopy unit announced the release of the Bullseye™ Anatomic Cruciate Reconstruction System, a novel guide system for anatomic cruciate ligament (anterior and posterior cruciate ligaments) reconstructions of the knee.
The Bullseye System, which provides surgeons with the ability to more precisely perform anatomic single-bundle and double-bundle cruciate reconstructions with a flexible and intuitive guide system, will be supported with new sizes of advanced Matryx™ Biocomposite Interference Screws.
A recently developed method for the repair of cruciate ligaments utilizes an anatomic approach via the insertion of the replacement ligament grafts into the anatomic “footprint” of the original ligament. Conmed Linvatec notes that this new approach to anatomic reconstruction requires advanced instrumentation, such as the Bullseye System, in order to more precisely place the graft in the correct anatomic position.
The Bullseye System consists of anatomic drill guides that visually depict the placement and size of the tunnel to be created and filled with the new ligament. The guides aid placement in the remnants of the original ligament and ensure that the ligament will be correctly positioned without damaging, or interfering with, nearby structures such as knee cartilage surfaces. The guides can be used to position 1 or 2 tunnels (single- or double-bundle) in the original ligament location, facilitating full anatomic reconstruction.
In conjunction with the new Bullseye guides, an expanded range of smaller sizes of Matryx Biocomposite interference screws for fixation of graft bundles will also be available. The Matryx brand of biocomposite screws are composed of self-reinforced bioabsorbable 96L/4D polylactic acid polymer imbued with beta–tricalcium phosphate particles. Matryx screws are absorbed by the body over time and foster new bone formation around the repaired ligament. The new smaller-diameter screw sizes (5.0-mm to 6.5-mm diameters) are the result of novel processing technology that allows CONMED Linvatec to manufacture such small biocomposite interference screws. The full Matryx product line now comprises 5.0-mm through 11.0-mm diameter screws.
For more information, contact
CONMED
525 French Road
Utica, NY 13502
phone 315-797-8375
fax 315-797-0321
www.conmed.com |
Total Hip Resurfacing System
Wright Medical
Group, Inc., announced that the
US Food and Drug Administration
(FDA) has given approval to the
company to market its original
CONSERVE® Plus
Total Hip Resurfacing System. Now
available in the United States,
this innovative total surface arthroplasty
system provides surgeons and their
patients a bone-conserving alternative
to traditional total hip replacement.
The FDA approval permits Wright to market CONSERVE® Plus in the original femoral and acetabular component configuration specified in its PreMarket Approval application and enables the company to initiate efforts to introduce additional enhancements to the system that are currently only available outside of the United States. The company intends to incorporate these innovative future product options into the CONSERVE® Plus System’s femoral and acetabular component offerings via the PMA Supplement pathway.
Wright Medical notes that the CONSERVE® Plus system is designed to offer pain relief and restoration of function while retaining as much healthy bone as possible and preserving future surgery options, including a primary total hip replacement.
The approval follows a successful clinical trial involving more than 1,300 patients, including those enrolled under Continued Access protocols, providing patient data in postoperative periods of up to 8 years in length. Wright Medical will commence surgeon training in the first phase of its introduction in the United States. The training is expected to begin immediately upon approval.
For more information, contact
Wright Medical Group
5677 Airline Road
Arlington, TN 38002
phone (800) 238-7117
fax (901) 867-9534
www.wmt.com |
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