MEDICREA’s LigaPASS(TM): FDA Approval and First Surgeries in the US

LYON, France, May 31, 2012 (BUSINESS WIRE) — Medicrea announces today the approval by the FDA of the LigaPASS(TM) spinal fixation system and the first LigaPASS(TM) surgeries performed in the U.S. by Dr. A. AMINIAN (Saint Joseph Hospital, Orange, CA. USA).Dr. AMINIAN commented after his first surgeries with the LigaPASS(TM) implant: “Until today, patients with dysplastic pedicles or poor bone quality did not allow me to obtain optimal vertebral fixation for correction of my deformity cases. Now with the development of the LigaPASS(TM) strap system, I am not only able to fixate the spinal vertebrae to the rod without the use of screws or hook, but also have a novel solution to perform vertebral derotation. With the addition of the LigaPASS component to the PASS LP(R) range, I believe this system is the best system currently available to address the most complex and challenging deformity procedures.” The LigaPASS(TM) system consists of a rod connector and sublaminar strap, allowing the surgeon to connect the vertebrae to the rod without the use of pedicle screws or hooks for spinal fusion surgery. This new technology offers the surgeon a pedicle-sparing fixation option when malformed or small pedicles are present, when poor bone quality prevents the use of traditional anchorage solutions or simply when the surgeon feels that this modern lacing technique is more appropriate than a traditional anchor. This novel technique provides European and American surgeons a versatile and safe option to treat challenging situations.The LigaPASS(TM) fixation system builds off the company’s core PASS LP(R) technology employing the load sharing technique ST2R (Simultaneous Translation on 2 Rods) for addressing both coronal and sagittal correction in the most complex and challenging deformities. In addition to the PASS LP(R) proprietary technique, the LigaPASS(TM) offers derotation capabilities, a maneuver that has never been allowed with existing bands and connectors.Denys SOURNAC, President and CEO, concludes: “With the LigaPASS entering the US market, our subsidiary Medicrea USA Corp. now has a technology platform approved by the FDA that can address all the complex indications of the spine through MIS, anterior and posterior approaches. We ambition to introduce the LigaPASS(TM) to key opinion leaders of this surgical field throughout the U.S. and Europe by the end of 2012.”