FDA, Cardinal Health Assess Scope of Potential Contamination Risk

Dr. Jeffrey E. Shuren MD, JD, Director - CDRH Offices: Office of the Center Director, released the following statement on Thursday (January 16, 2020): “On Jan. 11 and again on Jan. 15, 2020, medical device manufacturer Cardinal Health alerted its customers to...

U.S Health System Uses Medtronic Stealth Autoguide Cranial Robotic Guidance Platform

Phoenix Children’s Hospital is the first-ever health system in the U.S. to receive and deploy the newly FDA-cleared Medtronic Stealth Autoguide platform.

Cook Medical TriForce Peripheral Crossing Set Now Available

Cook Medical’s TriForce® Peripheral Crossing Set is now commercially available. As of January 2020, these products are available to physicians in the United States to support procedures to treat patients with vascular obstructions.

PENTAX Medical Launches IMAGINA Endoscopy System in U.S.

IMAGINA offers practitioners a modern user interface and unique endoscope design to provide excellent visualization, improve the operator experience and positively influence long-term patient care costs.

Spineology Announces Duo™ Angled Instrumentation System

Duo™ Angled Instrumentation System. The angled instrumentation supplements the Duo Lumbar Interbody Fusion System (Graphic: Spineology Inc.)

Spineology Inc., an innovator in anatomy-conserving spine surgery, is excited to announce the launch of the Duo™ Angled Instrumentation System. The angled instrumentation supplements the Duo Lumbar Interbody Fusion System and allows surgeons to efficiently address the L4-L5 disc space in cases where the iliac crest prevents collinear access to the disc space.

“Accessing the L4-L5 disc space when a high crest is present can be very challenging, especially when using a bladed retractor,” said Dr. John Malloy IV, Fort Lauderdale, Florida. “Compared to the traditional lateral systems I have used in the past, the design of the Angled Duo Portal Tube and supporting Angled Instrumentation makes these cases much easier as it allows me to quickly access the disc space, perform an efficient thorough discectomy, and place an implant with significantly less retraction of the soft tissue and neural structures.”

“Positioning bladed retractors in the optimal location to ensure the instrumentation enters the disc space at the proper angle is difficult in cases with a high crest,” said Dr. Kris Okumu, Daly City, California. “The design of the Angled Duo Portal Tube makes the placement and proper positioning of the Portal Tube very simple, which has significantly reduced my OR time in these cases. I have also been very pleased with the design of the Discectomy and Insertion Instrumentation. The set allows me to quickly address all areas of the endplates and place and fill the Duo Implant in a very efficient manner, which adds additional time savings.”

The Duo System features the only implant on the market that combines PEEK, titanium, and graft containment mesh elements. The implant, which is filled with bone after insertion, creates a large, endplate-conforming graft pack that expands up to 30mm in width to maximize load-sharing and minimize point-loading. Once filled, the Duo Implant provides 70 percent more load-sharing surface area when compared to a 22mm width traditional lateral implant of the same length. These features are designed to reduce subsidence, improve spinal correction maintenance, and support a robust fusion. In addition, the system significantly decreases the surgical access required to place the implant compared to traditional lateral systems. By minimizing the neural and soft tissue retraction typically required in these surgeries, the company believes the Duo System will reduce the retraction-related neurologic deficits commonly associated with the lateral approach.



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