Approvals

FDA Grants Expanded Approval for Intuitive Surgical’s Robot-Assisted Surgery Device

Intuitive Surgical received 510(k) clearance for a new indication for its da Vinci SP robot-assisted surgery device.

The new indication is for urologic surgical procedures that require very narrow access from a small incision appropriate for a single port approach. The company plans to pursue additional clearances for other applications.

The system includes three multi-jointed wristed instruments and a fully wristed 3D HD camera. The system allows for flexible port placement and 360 degrees of anatomical access.

FDA Clears Insulet’s Omnipod System

Tubeless insulin pump developer Insulet received 510(k) clearance for its Omnipod Dash insulin management system.

The Dash is optimized for use with the Contour Next One blood glucose meter to transfer blood glucose readings to the touch-screen personal diabetes manager.

The device uses Bluetooth to connect with the Omnipod Display and Omnipod View apps, giving users and caregivers access to their insulin therapy information on their smartphones.

Centinel Spine Gets Clearance for Interbody Fusion Device

The FDA granted Centinel Spine 510(k) clearance to market its FLX platform of integrated and non-integrated interbody fusion devices.

The 3D printed titanium devices feature porous radiolucent sections to reduce mechanical stiffness and improve visibility compared with solid titanium implants.

The devices also have a proprietary trabecular scaffold that allows for bony in-growth and on-growth throughout the implant. They are indicated for use at one or two contiguous levels with both autograft and/or allogenic bone graft.

FDA Clears EDAP TMS’s Focal One

EDAP TMS received 510(k) clearance for its Focal One device, used for the surgical removal of prostate tissue.

The device uses high intensity focused ultrasound to ablate prostate tissue and combines the use of MR and 3D biopsy data with real-time ultrasound imaging.

Using the device, urology surgeons can define precise contours around diseased tissue and remove a smaller portion of the prostate, lessening damage to healthy tissue and minimizing side effects.

LivaNova Aortic Heart Valve Approved in Japan

Japan’s Ministry of Health, Labor and Welfare approved LivaNova’s sutureless aortic heart valve for treating aortic valve disease.

The device, known as the Perceval sutureless valve, is designed to lessen the physiological impact of aortic valve replacement. It received the FDA’s approval in 2016.

The valve can be used in a variety of surgical methods, including traditional procedures and minimally invasive approaches.

K2M Group’s Cervical Plate System Receives FDA Clearance

The FDA granted 510(k) clearance to K2M Group’s Ozark cervical plate systems, designed for anterior screw fixation to the cervical spine in patients with deformity, tumor, trauma or degenerative disease.

The systems are available in two designs — the Ozark Guide and Ozark View — and both feature a locking cover that gives surgeons a clear view of the final lock position.

The devices offer a full range of plate and screw sizes and instrumentation for constrained, semi-constrained or hybrid screw constructs, and are compatible with K2M’s Cascadia 3D interbody systems.

OrthoSensor Earns Further 510(k) Clearance

The FDA granted OrthoSensor, a developer of sensor-assisted devices for total knee replacement, additional 510(k) clearance for its Verasense assisted technology.

The device is designed to help patients who complain of stiffness, pain and loss in range of motion following total knee replacement surgeries.

The clearance allows the device to be used with Zimmer Biomet’s Persona knee system for total knee replacement.

Icotec’s Interbody Cages Cleared by FDA

The FDA granted marketing clearance for Icotec’s BlackArmor interbody cages used for lumbar procedures.

The cages are designed to improve bony integration and post-operative visualization, and the clearance applies to a variety of surgical approaches including cervical and lumbar procedures.

The device’s material consists of continuous carbon fibers combined with polyether ether ketone (PEEK), an organic thermoplastic polymer, allowing consistent orientation of the carbon fibers for strength and mechanical durability.

OptoVue Gets Clearance for Blood Vessel Measurement Device

Fremont, California based OptoVue received 510(k) clearance from the FDA for its AngioAnalytics optical coherence tomography angiography blood vessel measurement technology.

The device provides high-resolution imaging of retinal blood vessels and is designed to help manage diseases that cause progressive blindness.