8 мар. 2012 г.

DePuy Receives PMA for TRUMATCH

What with their focus on precision, the engineers at DePuy Orthopaedics, Inc. must be especially thrilled…the company’s TRUMATCH Personalized Solutions with DePuy’s SIGMA RP Knee System has received Premarket (PMA) Supplement Approval from the FDA. Already in use in 17 countries, TRUMATCH Solutions for use with DePuy’s SIGMA Fixed Bearing Knee System was previously cleared in August 2011. And this made DePuy the only orthopedic company to have personalized instrumentation for use with both rotating platform and fixed bearing knees.

“We’re very excited about the opportunity to offer patients the world’s leading mobile bearing knee system, the SIGMA RP Knee, with TRUMATCH Personalized Solutions,” said Andrew Ekdahl, President, DePuy Orthopaedics, in the February 15, 2012 news release. “This approval means patients can now benefit from precise implant positioning, enabled by TRUMATCH Solutions, and the proven performance of both the SIGMA RP and Fixed Bearing Knee Systems, while increasing efficiency in the operating room.”

As indicated by the company, the TRUMATCH is the first system to utilize CT scans and computer software to guide the development and production of femoral and tibial cutting blocks that are individually prepared to match the actual bone surfaces of each patient. Also, TRUMATCH Solutions uses CT scans, rather than MRIs, for improved bone imaging, less scanning time and lower costs. DePuy states that procedures done with TRUMATCH Solutions also require less instrumentation and eliminate up to nine surgical steps compared to total knee replacement performed without TRUMATCH Solutions.

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