Spineart is pleased to announce that it has received Investigational Device Exemption (IDE) approval from the FDA to initiate a clinical trial to determine the safety and effectiveness of the BAGUERA® C Cervical Disc Prothesis. The single-level trial will compare the BAGUERA® C Cervical Disc Prothesis to another FDA approved arthroplasty device and will take place in up to 30 centers across the United States.
Jerome Trividic, president of Spineart USA, said, “Thanks to a fruitful collaboration with the FDA, we will be starting patient enrollment in the upcoming months. We are excited to bring BAGUERA® C to the United States, after more than a decade of successful patient outcomes outside the US”.
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, to accommodate the patient anatomy and to minimize vertebral endplate manipulation. The inner layer of the prosthesis’ endplates are coated with a diamond-like-coating to minimize wear. The load sharing design and the guided mobile nucleus are intended to prevent excessive constraints on the facet joints and adjacent levels.
Spineart USA announces over 1,000 patients treated with SCARLET® AL-T, its ALIF system launched in 2019. The implant was developed using the company’s flagship Ti-LIFE Technology, a titanium bone-like structure that supports bone cell adhesion and allows for bone ingrowth. A number of design features make SCARLET® AL-T unique: the 3D printed cages feature tunnels which prevent screw misalignment, the screws were designed with a triple lead and threaded end-tip, eliminating the need to drill or awl, the screw anti-backout system is both tactile and visual. A line extension with additional lordosis options will be launched later this year, along with the results of an in-vivo animal study, which will be presented at the North American Spine Society annual meeting. SCARLET® AL-T is comprised entirely of sterile packed implants, reducing the risk of contamination or infection.
Spineart is proud to announce the first TEKTONA® Vertebral Fragment Reduction surgery in Colombia. The surgery has been successfully performed by Dr Cesar DIAZ, Neurosurgeon in Hospital San Rafael de Bogota. Dr Diaz is very happy with the clinical outcome and the patient’s fast recovery.
Spineart sera présent au Congrès de la SFCR en tant que Silver Partner ! Nous vous attendons avec impatience pendant ces 3 jours !
As Silver Partner, Spineart will attend the annual SFCR! We are looking forward to seeing you during these 3 days!
Spineart’s strength has always been its collegial relationship with our customers. While COVID-19 has brought elective surgeries to a halt, we’re using this valuable down time to setup online education programs.
Among the initiatives, Spineart is happy to announce the launch of our SPINEART WEBINAR SERIES training program.
Twice a week, our Sales Forces have the occasion to interact live with Spineart’s Product and Clinical Project Managers. These Series consist of product focused modules which go over technical aspects and clinical updates on Spineart’s key products.
Every session will be recorded and those unable to attend will get a link to access later the recordings online. First two sessions were successfully followed by 80 participants all over the world and are already available for streaming on demand.
If you want to register, please contact Spineart Education team at: firstname.lastname@example.org
For more information on US Webinars, please contact Lisa Wilson at: email@example.com
Spineart’s strength has always been its collegial relationship with our customers. While COVID-19 has brought elective surgeries to a halt, we’re using this valuable down time to setup online education programs. Among the initiatives, Spineart is engaging with small groups of American surgeons every Wednesday evening (7pm EST – 4pm PST) via Zoom. These calls provide a forum for discussion amongst peers, for each spine surgeon to share their reality amongst colleagues, and together, commiserate on how we all forge ahead. The discussion topics are plentiful, ranging from non-operative treatment options to economic realities in different parts of the United States. We are always welcoming new participants – please send an email to firstname.lastname@example.org if you would like to have more information!