RAMAT POLEG, Israel, July 7 /PRNewswire/ -- Impliant Limited, a venture capital-backed company, today reported the initiation of a multi-center clinical trial for its Cushion-Bearing(TM) Femoral Head. The first patient, an 86-year old female hip fracture patient, received the Company's elastomer femoral head implant on Sunday night at Carmel Hospital in Israel. This follows the recent CE approval of the device for sale.
The Cushion-Bearing(TM) Femoral Head, a novel femoral prosthesis based on a proprietary polyurethane material and cutting-edge engineering, more closely resembles the body's natural joints than current hard-bearing prostheses. The implant has a metal core with an elastomer cover that demonstrates superior wear characteristics when articulating against native acetabular cartilage.
Ron Sacher, CEO, said, "The current outcomes of traditional hemiarthroplasty procedures are abysmal when compared to total hip arthroplasty. Impliant recognized several years ago the need to help this huge patient population. Today's enrollment of the first CBFH patient and the CE mark highlight an extremely successful research and innovation program to develop a better solution for partial joint implants that articulate against cartilage."
Impliant's randomized multi-center trial will compare the Cushion-Bearing(TM) Femoral Head to a traditional bipolar system in patients at Hadassah Hospital in Jerusalem, Assaf HaRofe Hospital in Tel Aviv, and Carmel Hospital in Haifa.
"The Cushion-Bearing(TM) Femoral Head has the potential to increase the longevity of hemiarthroplasty procedures and increase the quality of life for patients," said Moti Kligman, M.D. and Professor Moshe Roffman M.D., both joint arthroplasty specialists at Carmel Hospital. "We know that patients do not typically return to their pre-fracture levels of activity following a hemiarthroplasty procedure. Many patients experience groin pain and other complications that are related to the mismatch between a metal femoral head and the acetabulum. The Cushion-Bearing(TM) Femoral Head should be more gentle on the cartilage."
Impliant plans to introduce the Cushion-Bearing(TM) Femoral Head through a limited rollout to key European centers in the third quarter of this year. The Company is developing additional implants based on the Cushion-Bearing(TM) Implant concept.
Impliant Ltd. began operations in 2000 to commercialize a new class of cushion-bearing implants based on a proprietary elastomer material and cutting-edge engineering. The Company is backed by leading venture capital firms in Israel and the United States.
For more information visit our website at http://www.impliant.com/