FDA Gives 510K Clearance for a 30-year Knee Replacement From Smith and Nephew
Posted Apr 22 2010 9:38am
How long is my knee or hip going to last, everyone wants to know that answer and couple years ago wrote about it here. The FDA gave the stamp of approval to one company today that states their knee should last 30 years. I hope so for all those who have had knee replacements and for those who have had replacements for the original devices implanted. There’s quite a bit of that going on today. Having a device replaced is a more extensive surgical procedure than the original implant as there some clean up to do and sometimes a second implant has been done due to infection.
To test for durability, the time clock was moved up to simulate what a knee would endure in 30 years. This is something we all want to hear about, less surgical procedures on devices that last for sure. Recently in the news Johnson and Johnson reported recalling and phasing out one of their hip replacement products and purchased another company in the UK that develops and sells knees and hips.
It appears the technology is advancing pretty quickly here with knees and hips, good for the patients and doctors by all means. BD
MEMPHIS, Tenn., April 22 /PRNewswire-FirstCall/ -- As evidence of its drive to return knee pain sufferers to a lifetime of physical activity, Smith & Nephew ( SNN, LSE: SN) Orthopaedics Division today announces the results of unprecedented testing on its VERILAST technology for knee replacement implants. After simulating 30 years of physical activity on the company's LEGION™ knee replacement, VERILAST technology produced an 81-percent reduction* in wear, the leading cause of knee replacement failure.
The Food and Drug Administration (FDA) has reviewed the results and Smith & Nephew received 510k clearance for claims related to VERILAST technology's ability to "provide wear performance sufficient for 30 years of actual use under typical conditions." The consensus of scientific literature is that knee implants are expected to last 10 to 15 years.
"Physically active patients want to end their knee pain for good," said Joseph M. DeVivo, president of Smith & Nephew Orthopaedics. "We're working to make knee implants that last a lifetime—that's our goal, and we've validated VERILAST technology out to 30 years for a market that views 10 to 15 years as the gold standard. This is not an incremental improvement; it's a generational leap forward for active patients.
"VERILAST technology is the unique combination of our exclusive OXINIUM material and the most advanced XLPE on the market. Together, they yield virtually indiscernible wear. After performing wear simulator testing of the knee replacements over three continuous years, we have confirmed that this Smith & Nephew knee replacement made with VERILAST technology, under normal circumstances, is expected to last for 30 years."
Typically, if a knee replacement fails due to wear, the patient will undergo a "revision" surgery in which the original components will be replaced with more invasive, more expensive ones. While there may be some decrease in implant performance, the primary costs of revision surgery are in its risk of infection and bone loss for the patient and the procedure's cost for the healthcare system.