SCARLET®AC-T CERVICAL SECURED CAGE FDA APPROVAL
Spineart is pleased to announce the FDA approval of the SCARLET® AC-T cervical secured cage system. The SCARLET®AC-T combines the benefits of an interbody device and cervical plate in one implant. The locking mechanism of the screw head is completely integrated within the cage, reducing the profile and potential risks associated with dysphagia. The Titanium sandblasted surfaces of the implant facilitate primary stability and osseointegration.
The instrument set is designed according to Spineart’s philosophy of simplicity, featuring one compact box of intuitive instruments.
ROMEO®2 PAD POSTERIOR AXIAL DEVICE FDA APPROVAL
Spineart is pleased to announce the FDA approval for the ROMEO®2 PAD Posterior Axial Device, a posterior non pedicle supplemental fixation device intended for use as an adjunct to fusion in the lumbar spine.
The ROMEO®2 PAD Posterior Axial Device consists of two plates and a central core. It features 30° of plate poliaxiality, to adapt to the anatomy of the patient. The easy one-step locking mechanism allows the surgeon to compress, fix and lock the device at the same time. The instrument set follows the Spineart compact philosophy, featuring one box of intuitive instruments.
All Spineart implants are sterile packed and bar-coded for increased safety, procedure compliance and cost-efficiency.
About Spineart:
Spineart is a privately held medical device company focused on simplifying the surgical act by designing, developing and promoting safe and efficient solutions to spine surgeons, operating room teams, and patients.
Spineart is a pioneer in its field, having introduced unique patented and clinically validated technologies in the fields of Minimally Invasive Surgery, Motion Preservation, Fusion, Biologics, and Fractures Treatment.
Spineart markets a complete portfolio combining traceable barcoded sterile packed implants with compact instrument sets, thus proudly promoting greater safety, cost-efficiency, and compliance at the hospital.
For more information please contact us at contact@spineart.com or visit spineart.com.
BAGUERA®C STUDY
We are pleased to announce the excellent results of a prospective observational study showing the safety and effectiveness of the BAGUERA®C cervical disc prosthesis. The device was evaluated 2 years postoperative, based on clinical and radiographical data of 118 patients with symptomatic cervical degenerative disc diseases (SCDDD), treated by total disc replacement (TDR) using the BAGUERA®C prosthesis. This study was conducted in 5 hospitals or clinics across France, Belgium, Spain, Germany and Greece.
The clinical and radiographical results showed that TDR using the BAGUERA®C device is:
– a safe procedure with low complication rate and no device-related adverse event
– an effective surgical treatment of single or double levels SCDDD, either used alone or in combination with other techniques (hybrid surgeries)
For both techniques (TDR-only and hybrid surgeries) the preservation of mobility and the disc height restoration at the implanted level were demonstrated. These results will be presented during the 2014 NASS meeting in San Francisco in November.
PREMIERE : SPINEART LATERAL SURGERY
San Francisco, USA. Spineart is pleased to announce the first implantation of its lateral interbody device JULIET® LL in combination with the OTELO® MIS LATERAL Retractor.
Spineart has reached a new milestone, entering into the lateral approach market with an innovative full carbon fiber retractor that allows complete visualisation of the surgical site thanks to its radiolucent characteristics.
Dr Dimitriy Kondrashov, MD successfully performed the first case worldwide at St Mary Hospital in San Francisco. After the case, Dr Kondrashov commented: “The radiolucent design has allowed unparalleled visualization of the disk space and the placement of both the trials as well as the final implant under lateral fluoroscopic view. It made a very challenging multilevel degenerative scoliosis case safer and more straightforward. Being able to see the exact trial position has allowed me to avoid endplate violation and optimize anterior-to-posterior placement of the final lateral cages. I am looking forward to my next lateral case”.
All Spineart implants are sterile packaged and bar-coded for increased safety, traceability and cost-efficiency.
For more information, please contact us at contact@spineart.com9
SPINEART ACADEMY IN HAMBURG, GERMANY
In mid-march, the Spineart Academy in co-operation with GE Healthcare hosted an advanced training course on Motion, M.I.S. and Deformity technologies at the University of Hamburg, Germany. 20 participants from Chile, France, Spain, Portugal, Italy, Iran, Poland and the Kingdom of Bahrain had the opportunity to learn more about the latest innovations in total cervical disc replacement, management of adult scoliosis and minimally invasive treatment methods. During dedicated wet-lab sessions, all participants had the opportunity to train on M.I.S. surgical techniques through hands-on anatomical workshops. Thanks to prominent surgeon faculty from Belgium, France, and Germany, it was a successful and informative course!
SPINEART ACADEMY IN LAS VEGAS, USA
Earlier this month Spineart hosted a lab in Las Vegas, Nevada where 33 participants from the USA, Australia, Brazil, Mexico, and Colombia had the opportunity to learn more about the latest innovations in total cervical disc replacement, management of adult scoliosis and minimally invasive treatment methods for degenerative conditions.
All participants had the opportunity to train on M.I.S. surgical techniques through interactive presentations and hands-on anatomical workshops. Thanks to prominent surgeon faculty from the USA, Colombia and France, it was a successful and informative course!