Medtronic (NYSE:MDT) said today it won FDA 510(k) clearance for its CD Horizon fenestrated cement-augmented spinal pedicle screw set, designed to be used with Medtronic’s HV-R polymethylmethacrylate fenestrated screw cement.
The company touted the win as the 1st FDA approval for cement-augmented pedicle screws.
The newly FDA cleared screw set is indicated for use at spinal levels where structural integrity of the spine is not severely compromised, Fridley, Minn.-based Medtronic said, for patients who are diagnosed with advanced stage tumors involving the thoracic and lumbar spine.
“Current cancer treatments can weaken a patient’s bones and primary malignancies often spread to the spine, which cause considerable pain and are complex to manage. When placed into compromised bone, traditional screws run the risk of loosening over time. The ability to utilize cement augmentation directly through a fenestrated screw is a great advancement. It allows me to achieve immediate implant stability, which would not be possible with traditional non-augmented screws. More importantly this allows me to help to mobilize my patients more quickly,” Dr. Francis Shen said in a press release.
Medtronic said the CD Horizon fenestrated screw set is designed with 6 holes near the end of the screw to allow for controlled cement injection onto the targeted vertebral body after screw placement, with self-curing PMMA cement to increase pull-out strength.
“Palliative care is important for people with cancer, and Medtronic’s cement-augmented screws are a meaningful innovation that are designed to restore the integrity of the spinal column in patients with debilitating spinal tumors. The availability of our CD Horizon fenestrated screw set represents an important advance for surgeons and provides them with another option for a complex procedure,” spinal division prez Doug King said in prepared remarks.
The company plans to launch the CD Horizon fenestrated screw set this fall.
Yesterday, Medtronic said it won CE Mark approval in the European union for its Guardian Connect mobile continuous glucose monitoring system.
The medical giant said it is the 1st smartphone-enabled CGM system to win CE Mark approval for the company, and expects to launch the device on a country-by-country basis in the 2nd quarter of its fiscal year 2017.
The Guardian Connect allows diabetes patients to check their current glucose level on their mobile device at any time, and the system can be set to alert the user of high and low glucose levels through their smartphone device.
The company touted the system as the 1st and only mobile CGM system with customizable SMS text alerts, and said the system features automatic upload of data to the CareLink therapy management software.