Musculoskeletal News Roundup 15-Sept-17

September 15, 2017 | Blake Mossy

FUNDING

Spineology secured a $5 million investment in the form of a convertible debenture from Hermed Capital, a private equity firm located in Shanghai, China. The new capital will go towards additional commercialization, product development, and clinical research efforts. The company’s systems include the Duo System which aims to reduce the surgical access required for lateral procedures while providing a large conforming device footprint. The Rampart One System minimizes the exposure requirements associated with anterior spinal fusion procedures and is manufactured from Invibio PEEK-OPTIMA HA Enhanced material.

PRODUCT INTRODUCTION & UPDATE

DePuy Synthes launched its TRUMATCH titanium 3D-Printed Implants indicated for facial reconstruction, corrective jaw surgery and orthognathic surgery. The system, manufactured by Materialise, utilizes computer-aided surgical planning and a CT scan of the patient’s skull to create patient-specific implants.

K2M launched its EVEREST Minimally Invasive XTower instrumentation cannulated top-loading polyaxial pedicle screw system.  The device aims to provide a rigid reinforcement of EVEREST MI XT screw tabs, and can be used throughout an entire procedure.

NuVasive launched its LessRay, hardware and software designed to minimize overexposure to radiation in the O.R., specifically during minimally invasive spine surgery (MIS). The software offers dual benefits of lower radiation exposure and O.R. efficiency by allowing low-radiation x-ray images to exhibit similar diagnostic abilities as conventional, full-dose fluoroscopy images, and fewer fluoroscopic shots are needed.

Zimmer Biomet launched its Persona Partial Knee, a personalized and anatomically designed knee implant. The system is designed using ZiBRA Anatomical Modeling System to analyze a database of thousands of bones across the globe.  

REGULATORY

IMPLANET received 510(k) clearance from the FDA for its JAZZ Passer, a comprising spinal instrument and braided band technology that are compatible with all JAZZ platform implant connectors. The JAZZ Passer was designed in response to surgeon feedback and aims to facilitate the placement of the JAZZ band around anatomical structures.

Xtant Medical received 510(k) clearance from the FDA for the expanded indication of its Irix-A interbody spacer, including three new sizes and use with allograft. The system is comprised of a titanium ring surrounded by an outer PEEK composite ring and three screws, plus an optional titanium plasma coating to support osseointegration with the endplate.

 

CLINICAL

Bioventus announced the enrollment of its first patients in BONES, the company’s Observational Non-interventional EXOGEN Studies program. The study is indicated to collect real world data from use of EXOGEN, which uses low-intensity pulsed ultrasound to stimulate the body’s own bone-healing process.

Bodycad announced the completion of its first personalized restorations using its Unicompartmental Knee system. The uni knee uses imaging algorithms to produce a precise 3D image of the patient’s knee to yield a better fit and support of positive clinical results.

Cerapedics announced the publication of a 2-year follow-up data from an Investigational Device Exemption (IDE) clinical trial, led by the FDA, of the i-FACTOR Peptide Enhanced Bone Graft. The study indicated its statistical superiority in overall clinical success to autograft in anterior cervical discectomy and fusion (ACDF).

Globus Medical completed its first orthopedic trauma case using its ANTHEM Distal Radius Fracture fixation system for the treatment of traumatic wrist fractures. The system utilizes anatomically contoured plates for intraoperative versatility and screw design that supports fine-tuning in multiple directions.