NEWLY AVAILABLE, NEWLY APPROVED


Osteoconductive Suture Anchor

ArthroCare® Corp. has launched its new DoublePlay implant, a new suture anchor device intended for fixation of soft tissue to bone in surgical procedures such as rotator cuff repair. The company states that the DoublePlay implant is unique in terms of design and material.

The DoublePlay device is a fully threaded anchor and features an “eyeless” design that eliminates the risk of eyelet breakage, the most common mode of failure in standard absorbable anchors.

ArthroCare notes that DoublePlay is manufactured from a proprietary composite material, the first composite to be used in sports medicine with clinically proven osteoconductivity and replacement by bone.

DoublePlay has received US Food and Drug Administration clearance for fixation of suture to bone in the shoulder, foot, ankle, knee, hand, wrist, elbow, and pelvis. The device is preloaded with Magnum wire.

For more information, contact

ArthroCare
7500 Rialto Boulevard, Building Two, Suite 100
Austin, Texas 78735
phone (512) 391-3900; fax (512) 391-3901
www.ArthroCare.com


Digital Image Distribution

Orthocrat Ltd, a leading provider of orthopedic preoperative planning software, has introduced OrthoFlow, a management tool that is designed to enable orthopedic surgeons to distribute their patients’ digital images to clinic rooms in less time and with less administrative hassle.  Integrated with major PACS, OrthoFlow’s solution is aimed at increasing efficiency while ensuring the highest level of security and privacy for patient information.

After an initial log-in at a diagnostic workstation, surgeons can upload and review digital images and send them to a specific patient examination room. Once the surgeon enters the examination room, the selected digital images are pulled up on the screen with a simple swipe of an HID reader connected to the computer.  This eliminates the need to log into the PACS again and repeat the search for data, thus saving time.

The company notes that OrthoFlow also adds a high level of security and privacy for patients during clinical visits.  OrthoFlow’s embedded HID reader locks the computer screen while patients wait in the examination room, ensuring that no one except the surgeon can unlock the screen and view the file. 

For more information, contact

Orthocrat
phone (866) 717-0272
www.orthocrat.com



FDA Broadens Reclast Indication

The US Food and Drug Administration (FDA) has broadened the US indication for once-yearly Reclast® (zoledronic acid) Injection to include the prevention of new clinical fractures in patients who have recently had a low-trauma hip fracture.1

The FDA decision is based on safety and efficacy data from the landmark Recurrent Fracture Trial, published in The New England Journal of Medicine, showing a significant 35% reduction in the risk of new clinical fractures in patients treated with Reclast.2 The Recurrent Fracture Trial involved more than 2,100 men and women aged 50 and older with osteoporosis who had experienced a recent low-trauma hip fracture.2 Results showed that Reclast increased bone mineral density and reduced the risk of new clinical fractures by 35% compared with patients treated with placebo.2 The risk of new spine fractures was reduced by 46%.2 The incidence of all-cause mortality was 9.6% in the Reclast group and 13.3% in the placebo group.2

The active ingredient in Reclast is zoledronic acid 5 mg administered once a year.1

For more information about Reclast, contact

Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, NJ 07936-1080
phone 866-RECLAST
www.reclast.com


References

  1. Reclast® (zoledronic acid) Injection [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; June 2008.
  2. Lyles KW, Colón-Emeric CS, Magaziner JS, et al. for the HORIZON Recurrent Fracture Trial. Zoledronic acid and clinical fractures and mortality after hip fracture. N Engl J Med. 2007;537:1799-1809.
  3. US Department of Health and Human Services. Bone Health and Osteoporosis: A Report of the Surgeon General. 2004;88.