Spineology wins FDA 510(k) for Rampart Duo interbody fusion device

October 25, 2016 By Fink Densford Leave a Comment

Spinal tech developer Spineology said today it won FDA 510(k) clearance for its Rampart Duo interbody fusion system.

The St. Paul, Minn.-based company said its newly-cleared Rampart Duo is the 1st device of its kind to combine PEEK, titanium and graft containment mesh elements.

“Rampart Duo is an innovative interbody fusion device that builds upon Spineology’s OptiMesh technology. The 510(k) clearance of Rampart Duo opens the door to the commercialization of a family of hybrid PEEK and graft containment mesh implants designed for interbody fusion. The implant is a great addition to our anatomy-conserving product offering,” CEO John Booth said in a press release.

The Rampart Duo is designed to include PEEK spacer blocks position at each end of the device with a flexible porous graft containment mesh to create a central graft cavity. The mesh is designed to be filled with bone craft material in order to deploy the device in the anterior-posterior direction, Spineology said.

“The implant design allows for decreased retraction requirements when compared to current interbody systems. The minimized tissue retraction may reduce the potential for nerve damage and resultant leg pain associated with the lateral approach,” Dr. Sandeep Kunwar said in prepared remarks.

“The device has been anatomically designed. The PEEK spacer blocks are positioned on the lateral aspects of the vertebral body, where the bone is naturally strongest, to provide solid anterior support. In addition, the central graft containment mesh allows for broad device deployment which increases graft footprint and facilitates conforming apposition of the graft to the endplate for fusion,” Dr. Michael Wang said in a prepared statement.

“The small tubular retractor and streamlined instruments, including ones that allow for the placement of the device when a high iliac crest is present, may help preserve patient anatomy and limit operating room time,” Dr. Craig Kuhns said in prepared remarks.

Last month, Spineology said that it expanded its relationship with the Muscoloskeletal Transplant Foundation, making it the sole tissue provider for its allograft product lines.

The expanded deal makes MTF the sole provider of tissue for Minneapolis-based Spineology’s new Incite cortical fibers bone grafting solution.

Heraeus Medical Components and Myant partner on electrical sensing for textiles
Heraeus Medical Components (St. Paul, Minn.) and Toronto-based Myant have entered a partnership enabling Myant to use Heraeus’ Tectitoat for electrical sensing applications in textiles, the companies announced today. Tecticoat is a conductive polymer-based coating that can be applied to textiles to control electrical conductivity, electromagnetic shielding and electrostatic dissipation, making it suitable for integration… […]
Cook Medical’s peripheral artery set debuts in U.S.
Cook Medical recently announced the U.S. launch of its TriForce peripheral crossing set to support vascular obstruction procedures. The TriForce set is designed to be percutaneously introduced into blood vessels to support a wire guide while performing a peripheral intervention, according to the Bloomington, Ind.-based company. This device is also intended for injection of radiopaque… […]
Bayer and Exscientia partner to bring AI to drug discovery
Bayer (ETR:BAYN) announced that it is entering into a collaboration agreement with artificial intelligence drug discovery company Exscientia to identify and optimize novel lead structures for potential drug candidates in treating cardiovascular and oncological diseases. The agreement, announced earlier this month, is slated to see the companies work together on early research projects combining Exscientia’s proprietary… […]
GHO Capital acquires Ardena
European specialist investor Global Healthcare Opportunities, also called GHO Capital Partners, recently announced that it has acquired Ardena — a specialist contract development and manufacturing organization focused on early phase drug development. Financial terms of the deal, announced Jan. 9, were not disclosed. Get the full story on sister site Drug Discovery and Development. The […]
Albright Silicone launches 3D printed tooling for silicone molding
Albright Silicone (Leominster, Mass.) recently announced that it has added 3D printed tooling for LSR molding, touting the relative low coast and rapid turnaround the process offers for prototyping. “This capability of 3D printing and molding LSR is a helpful solution to customers’ problems when trying to develop and prove a concept before investing in… […]
BREAKING: Medtronic wins FDA approval for Micra AV
Medtronic (NYSE:MDT) has won FDA approval for its Micra AV — greatly expanding the number of people who could potentially benefit from leadless pacemaker technology. The medical device giant plans to start offering the Micra AV in a limited number of implanting centers in the coming weeks, with a full launch expected in the spring. FDA… […]
FDA reclassifies some medical image analyzers
The FDA today imposed stricter regulations on certain radiological medical image analyzers, reclassifying them from Class III to Class II. Affected products include computer-assisted detection (CADe) devices for breast cancer mammography, breast-lesion ultrasound, and lung-nodule and dental-caries radiography, the agency said. It defines these devices as those intended to identify, mark, highlight, or in any… […]
Medline Industries temporarily halts EtO sterilization at Illinois plant
This article has been updated with a comment from Medela. Medline Industries has temporarily closed its Waukegan, Ill., medical device sterilization operation to install nearly $10 million in emissions upgrades. The privately owned company uses the carcinogenic gas ethylene oxide (EtO) to sterilize its own and other companies’ devices at the plant. Medline did not… […]
Mojo Vision developing ‘smart’ contact lens
Mojo Vision is working with the FDA to develop a smart contact lens to help people with low vision. The lens overlays real-time contrast and lighting enhancements with zoom functionality and recently won FDA breakthrough device designation. “Receiving the Breakthrough Device Designation is a significant step in our research and development process. We look forward to… […]
FDA to EPA: Leave us out of your ethylene oxide rule
This article has been updated with comments from the FDA. The FDA has asked the Environmental Protection Agency to leave the FDA out of its proposal for stricter regulation of ethylene oxide (EtO) emissions, and the EPA complied. In an interagency comment on the EPA’s proposed rule governing commercial EtO users — which includes medical… […]
Clippart debuts stepper-controlled flow valve
Clippard recently launched a new stepper-controlled proportional valve for precision flow control. The Eclipse valve uses the industry’s most robust and powerful miniature linear actuator, according to Cincinnati-based Clippard. The patent-pending Eclipse is designed for liquid and gas delivery, medical, analytical and industrial automation requiring ultra-fine resolution and repeatability. The design also allows for custom… […]