Medical devices approvals, launches, accreditations

Departments - Regulatory

Vanta implantable neurostimulator; Articulating instruments for Senhance Surgical System


Vanta implantable neurostimulator

Medtronic plc received U.S. Food and Drug Administration (FDA) approval for Vanta, a high-performance recharge-free implantable neurostimulator (INS) with a device life of up to 11 years. It uses Medtronic’s AdaptiveStim technology for personalized pain relief that adapts to the patient’s movement or body position using a built-in accelerometer. AdaptiveStim technology automatically adjusts stimulation to maintain each patient’s optimal dose. The Vanta neurostimulator also provides full-body magnetic resonance imaging (MRI) access with Medtronic SureScan technology.

The Vanta neurostimulator represents a 10% increase in longevity compared to PrimeAdvanced, Medtronic’s previous generation recharge-free device, while also being 20% smaller with a more rounded, ergonomic contouring for enhanced comfort.


Articulating instruments for Senhance Surgical System

Asensus Surgical Inc., a medical device company digitizing the interface between the surgeon and patient for a new era of Performance-Guided Surgery, received FDA 510(k) clearance for 5mm diameter articulating instruments, adding to the Senhance Surgical System technology platform. Articulating instruments increase access to difficult-to-reach areas of the anatomy by providing two additional degrees of freedom. These instruments have previously received CE Mark for use in the European Union.

“Bringing the benefits of 5mm articulating instruments to the Senhance Surgical System in the U.S. will widen the clinical utility and value of our platform,” says Anthony Fernando, Asensus Surgical president and CEO. “Combining articulation and haptics with augmented intelligence is a very promising development for Performance-Guided Surgery.”