NEWLY AVAILABLE, NEWLY APPROVED


Pre-Filled Flowable Hemostat

Johnson & Johnson Wound Management, a division of ETHICON, INC., announced the launch of SURGIFLO™ Hemostatic Matrix with FlexTip, a pre-filled, flowable hemostat that offers surgeons the option to customize the consistency of the product and has a flexible tip for precise placement.

The new bendable applicator tip has "memory" designed to ensure it stays at the optimum angle for easier access and exact product placement. ETHICON notes that the product flows easily into rough or uneven surfaces for complete coverage and rapid hemostasis. When mixed with thrombin, it has been shown to achieve hemostasis in less than 2 minutes in an in vivo animal spleen model.

SURGIFLO Hemostatic Matrix is indicated for surgical procedures (except urologic and ophthalmic) for hemostasis, when control of capillary, venous, and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical.

SURGIFLO Hemostatic Matrix can be used with or without thrombin to achieve hemostasis.

SURGIFLO Hemostatic Matrix cannot be used in the closure of skin incisions because it may interfere with the healing of skin edges. It is not indicated for use in intravascular compartments because of the risk of embolization and is not for use in patients with known allergies to porcine gelatin.

For more information, contact

ETHICON
Route 22 West
Somerville, NJ 08876
Phone 877-384-4266
www.ethicon.com


Lumbar Plate System

Zimmer Holdings, Inc. announced that the first cases using the Trinica® Anterior Lumbar Plate (ALP) System have been completed in St. Louis, Missouri. The Trinica ALP System is the first anterior lumbar plate system to accommodate vertebral body variation through multiple plate configurations with both fixed-and variable-angle screws for an enhanced bone-plate interface. Zimmer Spine expects to complete its full release of the Trinica ALP System in the United States, Europe, and Australia by the end of 2006.

The Trinica ALP System gives surgeons the ability to combine fixed-and variable-angle screws and uses an All-Through-One Guide to accommodate drilling, tapping, and screw insertion, providing consistent reproducible screw placement while protecting soft tissue. Both the lumbar and sacral plates are available in a selection of deficit-filling configurations.

For more information, contact

Zimmer
P.O. Box 708
1800 West Center Street
Warsaw, IN 46581-0708
Phone 800-613-6131
www.zimmer.com


Percutaneous Suture Shuttling Device

DePuy Mitek, Inc. has announced the introduction of the CHIA PERCPASSER™ percutaneous suture shuttling device. In addition to enabling the access to target anatomy that a percutaneous approach provides, the CHIA PERC-PASSER™ is small enough to pass through a 18g spinal needle; this allows precise placement of sutures without cannula restrictions in the limited working area of the subacromial space and glenohumeral joint.

The CHIA PERCPASSER™ is a 19-inch-long device made out of braided nitinol wire with a kite (loop) on one end. It is introduced percutaneously, kite end first, through an 18g spinal needle in the desired location. The spinal needle is then removed and the kite end of the CHIA PERCPASSER™ is retrieved with a grasper through the appropriate cannula. The suture is placed through the kite end of the CHIA PERCPASSER™ and withdrawn percutaneously. The suture is then removed from the CHIA PERCPASSER™ and stored percutaneously for later retrieval.

The percutaneous organization provides both external and internal visual confirmation of sutures being managed arthroscopically. DePuy Mitek notes that this methodical, minimally invasive suture management offered by the CHIA PERCPASSER™ can address a variety of surgical repairs, including rotator cuff, shoulder instability, and meniscal repairs.

To learn more, contact

DePuy Mitek
325 Paramount Drive
Raynham, MA 02767
Phone 800-382-4682
www.depuymitek


Polymer Suture Implant

Axya Medical Inc. has announced the launch of its new Polymer Suture Implants, commenting that this evolution in suture anchor technology and design exhibits high strength and radiolucency and it is much less expensive than either metal or bioabsorbable implants. Axya is launching this product in response to requests of surgeons to develop a more cost-effective implant with high-performance characteristics.

Axya is releasing the new anchor to address the growing number of soft-tissue injuries that occur each year. Approximately 450,000 surgeries are performed to repair rotator cuff injuries alone. The new polymer implant compliments Axya's existing family of patented suture anchors and is designed to deliver cost-effective performance.

Axya's polymer implant is available in 3-mm, 5-mm, and 6.5-mm diameters and comes preloaded with either 2 strands of uniquely colored, proprietary weldable suture or high-strength Force Fiber™ suture. Its radiolucent design eliminates interference with magnetic resonance imaging and is transparent on radiographs.

For more information, contact

Axya Medical, Inc.
100 Cummings Center, Suite 444C
Beverly MA 01915
Phone 978-232-9997
Fax 978-232-9998
www.axya.com


Absorbable Surgical Hemostat

Medafor, Inc. has announced that the Arista™ AH Absorbable Hemostat has received FDA approval. Medafor notes that the Arista AH has been distributed internationally since 2002 and has compiled a record of surgical success around the world as an easy-to-use, efficacious, and safe hemostat. In the United States it is indicated for most types of surgery, including cardiac, orthopedic, spinal, and general surgical applications.

Medafor notes that Arista AH consists of Medafor's patented Microporous Polysaccharide Hemospheres (MPH®), a plant-based, flowable powder engineered to rapidly dehydrate blood, enhancing clotting on contact. Arista AH facilitates the formation of a highly resilient, natural clot within just a few minutes, regardless of the patient’s coagulation status.

Arista AH is the only new-generation surgical hemostat that is instantly ready to use, requiring no mixing, no addition of patient blood or other components, and no special handling or storage conditions. The company points out that preclinical evaluations, clinical studies, and surgical use have shown the hemostatic capabilities of Arista AH to be comparable to the current popular choice of surgical hemostatic materials while its unique formulation allows for rapid absorption. Arista AH is fully absorbable; studies find no trace of the material at the wound site within 24 to 48 hours of application, and, because Arista AH degrades rapidly, it does not promote infection.

For more information, contact

Medafor
2700 Freeway Boulevard, Suite 800
Minneapolis, MN 55430
Phone 877-MED-AFOR
fax 763-571-1035
www.medafor.com


Posterior MIS Cervical Access

Endius Incorporated has announced the availability of NexPosure™, a new product that provides surgeons with minimally invasive access to the posterior cervical spine.

Based on the company's FlexPosure® access platform developed for minimally invasive lumbar surgery, NexPosure provides for minimally invasive access to the posterior cervical region of the spine, sparing crucial muscles and attachments in this region of the spine. Endius stresses that, just as preserving precious muscles in the lumbar region reduces tissue trauma and postoperative pain and speeds return to normal activities of daily living, the same results can be expected in the cervical region.

NexPosure features include oval pivoting tube in all planes for effective binocular visualization and access to the posterior spine; radiolucence, enabling spinal landmarks to be viewed, while light shading of device under fluoroscopy enables easy identification of exposed area; a biased skirt, providing a targeted approach to cervical spine and upper thoracic anatomy; and the availability of variable lengths to accommodate variability among patients. NexPosure’s locking and pliable skirt is designed to enable effective minimally invasive exposure with lower intramuscular pressures generated than by traditional rigid retractors.

For more information, contact

Endius
23 West Bacon Street
Plainville, MA 02762
Phone 800-955-6358
fax 508-695-2501
www.endius.com