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December 5th – December 11th

December 7th: Tornier Receives FDA Clearance for the Salto Talaris(TM) Anatomic Ankle Prosthesis

Tornier, a global orthopaedic company and a leader in the market for extremity joint systems, today announced that its Salto Talaris(TM) anatomic ankle prosthesis has been cleared by the United States Food and Drug Administration ("FDA") for commercial use by U.S. physicians. The Salto Talaris(TM) is a newly designed version of the Salto(TM) Ankle Prosthesis, which has been successfully implanted in Europe for the last 9 years.

Doug Kohrs, President and CEO of Tornier commented, "The Salto Talaris(TM) is a next generation ankle replacement that mimics the anatomy and flexion/extension movements of the natural ankle joint. This innovative surgical solution is designed to provide patients with much more mobility than a traditional ankle fusion and more importantly, should also offer patients an improved quality of life."

The Salto Talaris(TM) anatomic ankle is intended for use as a total ankle replacement to relieve pain and significant disability in patients with ankle joints damaged by severe rheumatoid arthritis, post traumatic arthritis, degenerative arthritis, and/or failed previous ankle surgery. The first U.S. implantation of the Salto Talaris(TM) occurred yesterday at Cleveland Clinic. The surgery was performed by Brian Donley, M.D., Vice Chairman of the Department of Orthopaedic Surgery at Cleveland Clinic.

The Salto Talaris(TM) is the latest addition to Tornier's comprehensive orthopaedic extremity implant product line in the United States. This innovative product line includes the Aequalis® cemented, press-fit, and reversed shoulder arthroplasty prostheses, a proximal humeral fracture treatment system as well as a total elbow and radial head arthroplasty prostheses.

December 11th: CryoLife Receives FDA 510(k) Clearance for ProPatch(TM) Soft Tissue Repair Matrix

CryoLife, Inc., (NYSE: CRY ) a biomaterials and biosurgical device company, today announced that it has received 510(k) clearance from the Food and Drug Administration (FDA) for its ProPatch(TM) Soft Tissue Repair Matrix. ProPatch, developed from bovine pericardial tissue, is used to reinforce weakened soft tissues and provides a resorbable scaffold that is replaced by the patient's own soft tissue.

"ProPatch provides an effective alternative to the products available for soft tissue repair," said Steven G. Anderson, President and Chief Executive Officer, CryoLife, Inc. "The indications for its use are broad and varied, particularly for hernia repairs in which the use of a natural tissue product, such as ProPatch, is preferred."

In addition to abdominal and chest wall repair, ProPatch Soft Tissue Repair Matrix is indicated for the reinforcement of soft tissues, including muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures. ProPatch can also be used to reinforce tissues repaired by sutures or by suture anchors during tendon repair surgeries, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.

In 2005, soft tissue repair was a $600 million market in the U.S., and is anticipated to grow at a rate of 14 percent annually until 2010, according to a 2006 report by Millennium Research Group. It is estimated that by 2010, the U.S. ventral hernia market alone will approach $350 million with procedures nearing the 300,000 mark annually.

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