Following a renewal and two follow–up certification audits recently performed by three independent notify bodies, Spineart is proud to announce that its activities of Design, Manufacturing and Sales of medical implants under ISO 13485 and 93/42/EEC Medical Device Directive have been approved until May 2024.
Spineart is proud to announce the first worldwide surgery using SCARLET® AL-T HL, the new Hyperlordotic Secured Lumbar Anterior Cage.
On November 10th 2020, surgery with the new SCARLET® AL-T HL Hyperlordotic Secured Lumbar Anterior Cage was successfully performed in the United States by Dr. Jeffrey E Deckey from Orange, CA.
Dr. Deckey commented on the new system that, “The introduction of the Hyperlordotic SCARLET® AL-T cage will provide significant improved options with regards to restoring sagittal balance in spinal deformity. With varying degrees, one can dial in the correct amount of correction to appropriately match the lumbar lordosis and pelvic incidence.”
SCARLET®AL-T HL is a cage utilizing the Ti-LIFE Technology, an enhanced manufacturing process of titanium cages, based on 3D printing technology, that mimics trabecular bone-like structures.
Following the recent FDA approval to initiate a pivotal IDE clinical study for the BAGUERA® C artificial cervical disc at 1-level, Spineart is proud to announce that it has received approval from the FDA to initiate as well a pivotal IDE clinical study for BAGUERA® C at two contiguous levels.
Both studies will be randomized controlled trials comparing the BAGUERA® C artificial cervical disc to another FDA approved arthroplasty device and they will take place simultaneously at up to 30 centers across the country.
BAGUERA® C Cervical Disc Prosthesis
The BAGUERA® C Cervical Disc Prosthesis is an MRI compatible disc. The endplates of the BAGUERA® C are anatomically shaped and the inner layers are coated with a diamond-like material that features a low coefficient of friction. The load sharing design and the guided mobile nucleus are intended to prevent excessive constraints on the facet joints and adjacent levels
Caution Investigational Device, Limited by Federal (or United States) Law to Investigational Use
Spineart is proud to announce the first surgeries of PERLA® TL, the new Posterior Thoracolumbar Fixation System.
On August 17th 2020, the first world-wide surgery with the new PERLA® TL Posterior Thoracolumbar Fixation System was successfully performed in the United States by Dr. Vivek Kushwaha from Houston, TX. Shortly after, on September 18th 2020, the first surgery in Europe was performed by Dr. Strube in Germany.
Dr. Kushwaha commented on the new system that, “The PERLA® TL system is well thought out and intuitive for my staff. With the updated reduction options, dual lead threads and the ability to use a 6.0mm rod, I can efficiently treat a wide range of patients.“
Dr. Strube said “I had a very good feeling with the whole set. Instrumentation worked seamlessly all along the surgery. Screws also felt great with a good grip and a large range of diameters and lengths available.”
PERLA® TL Posterior Thoraco-Lumbar Fixation system combines a compact set of simplified instrumentation with smart instrument design. The system offers a complete range of sterile-packed bar-coded implants, which include pedicle screws with the following innovative features: Friction Tulip Head with Double Rod Diameter Compatibility and a Screw Shaft incorporating a Dual Core Dual Thread design.
Spineart is proud to announce the first surgeries of TRYPTIK®Ti, the new Cervical Cage System.
On August 24th 2020, the first world-wide surgery with the new TRYPTIK®Ti Cervical Cages was successfully performed in the United States by Dr. Rishi Wadhwa from Shreveport, Louisiana USA. Shortly after, on August 28th 2020, the first surgery in Europe was performed in Germany.
TRYPTIK®Ti is a cervical cage system utilizing Ti-LIFE Technology, an enhanced manufacturing process of titanium cages based on 3D printing technology, that mimics trabecular bone-like structures.
Spineart is proud to announce the first SCARLET® AL-T ALIF surgeries have been carried out in the UK. The surgeries were successfully completed using our Ti-LIFE Technology cage in the North West and South Wales. Both surgeons are very happy with the clinical outcome and the simplicity of these new instrument sets. We wish the patient’s a speedy recovery.