FDA Approval and First US Surgeries For Medicrea’s LigaPASS™ Spinal Fixation System

In short

French spinal company Medicrea has announced the FDA approval of its LigaPASS™ spinal fixation system and the first US surgeries. The US clearance follows the gaining of  EU CE mark approval in May 2011.

Background

The LigaPASS™ 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™ fixation system builds on the company’s core PASS LP® 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® proprietary technique, the LigaPASS™ offers derotation capabilities, a manoeuvre that has hitherto not been possible with existing bands and connectors.

Clinician comments

Dr. A. Aminian from Saint Joseph Hospital, Orange, California commented after his first surgeries using the product: “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™ 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® range, I believe this system is the best system currently available to address the most complex and challenging deformity procedures.”

Company comments

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 LigaPASSTM to key opinion leaders of this surgical field throughout the U.S. and Europe by the end of 2012.”

Source: Medicrea, Business Wire