FDA approval for PyroCarbon implant for midfoot osteoarthritis

NewsBot · Jun 10, 2006

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Press Release:
Ascension Orthopedics Receives FDA Approval For PyroCarbon Foot Implant
10 Jun 2006 - 0:00am (PDT)

Ascension Orthopedics, Inc. announced today that it has received FDA approval on the first PyroCarbon implant for the foot. The Ascension(R) PyroSphere(R) implant is designed for the fourth and fifth tarsometatarsal joints of the foot and is intended for people suffering from the debilitating effects of arthritis in the foot.

"We are very pleased that the FDA has approved the PyroSphere(R) for the lower extremity. We are looking forward to providing the benefits of our implants to the foot and ankle surgeon," said Robert Martin, CEO of Ascension Orthopedics.

The Ascension(R) PyroSphere(R) is a revolution in TMT arthroplasty providing a new option to foot surgeons. The PyroSphere(R) is manufactured from the patented material, On-X(R) Carbon, which offers characteristics superior to those of other pyrocarbon material and is available only to Ascension Orthopedics. The material has shown improved wear qualities compared to other industry standard materials, thus enhancing the life of the implant.

The Ascension(R) PyroSphere(R) is the first PyroCarbon implant to be approved by the FDA in the lower extremity. This approval adds to the many firsts for Ascension Orthopedics in the extremity market.

"Our goal is to provide our customer, the extremity surgeon, with new and innovative solutions. Ascension will continue to lead the market in the development of small joint implants and innovation in extremity surgery," adds Robert Martin.

The company has expanded its product platforms to include arthroplasty, trauma, and tissue regeneration. Ascension currently offers more than ten arthroplasty products, a complete elbow trauma set, and a tissue regeneration portfolio that includes a nerve conduit and an adhesion prevention product. The entry into the foot market for Ascension marks its continued growth into the upper and lower extremity market.
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