Implanet granted US FDA clearance for Jazz Passer

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Implanet Jazz Passer
Implanet’s Jazz Passer

Implanet has received US Food and Drug Administration (FDA) clearance to market the new Jazz Passer. The technology comprises new passer instruments and a variation of the Jazz Band braid, the Jazz Passer Band.

According to a press release, the new band is compatible with all Jazz platform implant connectors. It is designed to replicate the mechanical performance of Jazz Band braid.

Jazz Passer is engineered to facilitate placing the band around anatomical structures. The release states that this simplified system should drive surgeon adoption of Jazz Band technologies.

The Jazz platform is intended to treat all degenerative, scoliosis-deformity and trauma-tumour pathologies in adolescents and adults.

Régis Le Couedic, Implanet’s Product Development & Manufacturing director, says, “This project’s challenge lay in the need to retain our Jazz technology’s proprietary performance characteristics. Our goal was also to develop simple instrumentation that provides the surgeon tactile feel when passing the braid around bony structures…the combination of the new braid and passers [make] it even easier to use Jazz, notably in the areas of degenerative and complex spine surgery, which account for most spine operations.”

Jazz Band radiological results

Independent radiological results for the Jazz Band were presented at the Scoliosis Research Society’s Annual Meeting in Philadelphia, USA (SRS; 6–9 September). A white paper concerned with the adolescent idiopathic scoliosis discussed analyses of 3D radiological reconstructions with EOS 3D Service (EOS Imaging).

The study analysed 3D radiological reconstructions of 60 patients treated with the ‘frame’ technique, using Jazz Band and Jazz Frame implants. The rigid frame facilitates posteromedial translation, resulting in comparable axial rotational correction as compared to the traditional ‘All-Screw’ technique. It is intended to preserve the advantage of sublaminar implants for restoration of sagittal balance.

“Although, for many surgeons, pedicle screws represent the gold standard in treating idiopathic scoliosis, sublaminar bands should be considered as part of the therapeutic arsenal… Their beneficial action on the sagittal balance has been proven. Their excellent biomechanical properties enable considerable correction forces to be applied without running the risk of pulling out the concave screws”, says orthopaedic surgeon Brice Ilharreborde (Paris, France). “The frame technique combined with the use of Jazz implants makes it possible to optimise axial correction while respecting the patient’s sagittal alignment”.

Implanet initiated a prospective, multicentre clinical study of the Jazz Band last year. The research is designed to document outcomes in adult degenerative and adult deformity indications.

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