This article is part of the Arthritis Archives.
Dateline: January 12, 2002
Ascension MCP FDA Approved
In November 2001, the FDA (the United States Food and Drug Administration) approved for marketing the Ascension MCP, a two-component total joint replacement for the metacarpophalangeal joint of the hand.
The Ascension MCP from Ascension Orthopedics, Inc., the first two-component MCP total joint replacement to receive FDA pre-market approval, is expected to be available in the United States this month (January, 2002).
The Ascension MCP is regarded as a new concept and significant breakthrough in hand surgery. The development of the product began in 1977 as a collaborative effort with Mayo Clinic hand surgeon, Robert Beckenbaugh, M.D. The new component is made of strong, low-friction, biologically fixed, and biologically inert PyroCarbon material. Prior to the Ascension MCP, the only implants approved for use in the MCP joint were single-piece silicone rubber spacers.
Clinical Results
The Ascension MCP allows for replacement of the diseased joints with a design anatomically close to the patients own joints, which does not require the use of cement for fixation. Clinical study results demonstrated that the Ascension MCP effectively:
- relieves pain
- improves and preserves motion
- reduces dislocation or subluxation of MCP joints in patients with osteoarthritis, rheumatoid arthritis, and arthritis due to trauma
The Ascension MCP was introduced in Europe in January, 2000 and has also been granted regulatory approval in Canada and Australia.
Related Resources
Source: PRESS RELEASE: November 2001 FDA Approval: Ascension Orthopedics Receives FDA Approval For The Ascension MCP PyroCarbon Total Joint
First published: 1/12/2002
