BAGUERA® C Cervical Disc Prosthesis and Navigated Instruments have received CE Approval under the MDR Regulation!
We’re thrilled to share another key milestone for the company; BAGUERA® C Cervical Disc Prosthesis, and our range of navigated instruments, are now CE Marked under the MDR 2017/745 (Medical Device Regulation) by the notified body TUV Sud.
What is MDR and why does it matter?
The MDR is the set of regulations that control the design, clinical, production and distribution steps of medical devices in Europe entering in force in May 2024. A number of requirements, such as technical files and clinical investigations, must be met in order to be compliant, which in turn ensures a higher level of patient safety.
Spineart is committed to certifying our complete portfolio under the MDR regulation by May 2024. To achieve this goal, we are fully invested in advancing our quality system and clinical studies.
This is the first in a long line of achievements Spineart will be announcing soon.
SPINEART AND ECENTIAL ROBOTICS ANNOUCE A PARTNERSHIP TO CO-DEVELOP SPINE SURGERY APPLICATIONS AND CO-MARKET THE ECENTIAL ROBOTICS’ OPEN ROBOTIC SURGERY PLATFORM
Plan-les-Ouates (Geneva), Switzerland, and Gières (Grenoble), France, December 16, 2022 – Spineart, a leading provider of spine surgery implants and eCential Robotics, a growth MedTech company that designs and produces an open system unifying robotics, surgical navigation, and 2D/3D robotic imaging, today announced they entered a long-term collaboration agreement.
The collaboration between the two companies involves research and development, marketing, and commercialization. Training centers for augmented spine surgery trial, both in the United States and Europe, will be available to surgeons in 2023. With a streamlined workflow and a smartphone-inspired user interface, spine surgeons will benefit from eCential Robotics’ state-of-the-art integrated platform, fully compatible with Spineart’s comprehensive and proven portfolio of innovative spine implants.Download the press release
150 U.S. PATIENTS TREATED IN EACH OF THE ONE AND TWO-LEVEL IDE CLINICAL TRIALS OF THE SPINEART BAGUERA® C CERVICAL DISC PROSTHESIS
LAGUNA HILLS, CA, December 13th, 2022 – Spineart USA Inc. announced today that surgery has been performed on 150 patients in both the one and two-level for a total of over 300 patients to date in the U.S. Investigational Device Exemption (IDE) Clinical Trials of the BAGUERA® C Cervical Disc Prosthesis. The BAGUERA® C implant is an investigational device in the U.S. designed to reconstruct the cervical disc following discectomy for symptomatic cervical disc disease.
Just over one year after the start of the two studies in more than 25 sites, this milestone surpasses our enrollment midpoint.Download the press release
100 U.S. PATIENTS TREATED IN THE TWO-LEVEL IDE CLINICAL TRIAL OF THE SPINEART BAGUERA® C CERVICAL DISC PROSTHESIS
100 U.S. PATIENTS TREATED IN THE SINGLE LEVEL IDE CLINICAL TRIAL OF BAGUERA® C CERVICAL DISC PROSTHESIS
LAGUNA HILLS, CA, April 21, 2022 – Spineart USA Inc. announced today that surgery has been performed on 100 patients in the single-level U.S. Investigational Device Exemption (IDE) Clinical Trial of the BAGUERA® C Cervical Disc Prosthesis. The BAGUERA® C implant is an investigational device in the U.S. designed to reconstruct the cervical disc following discectomy for symptomatic cervical disc disease.
Spineart is currently conducting, in parallel, a single-level and two-level IDE Clinical Trial of the BAGUERA® C Cervical Disc Prosthesis at more than 20 sites in the U.S. The two-level study is also expected to hit the 100-patient benchmark in the coming month, bringing the total surgeries performed to more than 200.Download the press release