Recent Food and Drug Administration approvals

Products from Boston Scientific, Precision Spine; Longeviti Neuro Solutions

PHOTO: BOSTON SCIENTIFIC

Boston Scientific received approval of its fourth generation Vercise Genus Deep Brain Stimulation (DBS) System. The portfolio, approved for conditional use in a magnetic resonance imaging (MRI) environment, consists of a family of Bluetooth-enabled, rechargeable and non-rechargeable, implantable pulse generators (IPGs) that power Cartesia directional leads.

DBS devices can treat the symptoms of Parkinson’s Disease (PD) by delivering targeted electrical stimulation via surgically implanted leads in the brain connected to an IPG. http://www.bostonscientific.com/dbs

Precision Spine received 510(k) clearance to use the Dakota ACDF Standalone System as treatment for degenerative disc disease (DDD). The system features a titanium plate polyetheretherketone (PEEK) cage with cortical cancellous screws for maximum support and a generous cavity for autogenous bone graft to help facilitate fusion.
PHOTO: PRECISION SPINE

Dakota ACDF is indicated for use in skeletally mature patients with DDD of the cervical spine (C2-T1) at one or two disc levels with DDD defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. https://www.precisionspineinc.com

Longeviti Neuro Solutions received 510(k) clearance for the ClearFit implant for post-operative imaging using ultrasound. A neuro reconstructive implant used by surgeons to reconstruct a patient’s cranium, ClearFit implants are implantable, patient-specific prosthetics. The company’s innovative solutions for complex brain surgery is advancing neurosurgery using low-profile intracranial devices that address the functional and reconstructive needs of patients with neurological conditions. https://longeviti.com
PHOTO: LONGEVITI NEURO SOLUTIONS
April 2021
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