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Recently, there has been lots of exciting developments in the minimally invasive surgery (MIS) interbody fusion device market. Here is a pair of announcements in the industry we would like to highlight:
Spinal Elements Announces FDA Clearance for Expandable Interbody Fusion Devices
Spinal Elements announced it has received FDA 510(k) clearance to market its line of expandable interbody fusion devices. The FDA clearance covers expandable interbody devices for posterior, anterior and lateral access to the lumbar spine. According to a company release, the lordotic angle can be increased during expansion with posteriorly placed and anteriorly placed devices and the coronal tilt can be changed during expansion with laterally placed devices. The devices will be made primarily with radiolucent polyetheretherketone material and Spine Elements’ Ti-Bond porous titanium coating.
“We believe the market for expandable interbody devices will continue to grow, and the devices that were cleared will allow us to continue to grow our portfolio of proprietary solutions for our customers,” Jason Blain, president and cofounder of Spinal Elements, said in the release. “While these expandable devices will work well with our conventional spine surgery platforms, we also believe they will complement our MIS procedural options as well, as we look to increase our presence in posterior MIS solutions.”
According to the release, Spine Elements expects to begin clinical procedures with the devices later this year and expects an initial launch of the expandable devices in early 2017.
SeaSpine Introduces Hollywood™ VI NanoMetalene® Interbody Device
SeaSpine Holdings Corporation, a global medical technology company focused on surgical solutions for the treatment of spinal disorders, recently announced the full commercial launch of its Hollywood™ VI NanoMetalene® transforaminal lumbar interbody fusion device.
Hollywood VI NanoMetalene, which is commercially available and has been successfully implanted, is indicated for use in spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). It is the most recent device to leverage SeaSpine’s exclusive rights to the NanoMetalene technology within the spine market. This implant adds to the NanoMetalene family of products, which already includes the Hollywood NanoMetalene, Ventura™ NanoMetalene and cervical Cambria™ NanoMetalene interbody devices.
NanoMetalene is a sub-micron layer of commercially pure titanium molecularly bonded to a PEEK-OPTIMA® polymer from INVIBIO®. It is applied in a proprietary high-energy, low-temperature surface process, which is different than other coating applications and allows for titanium nano topography to encompass the entire implant. The NanoMetalene coating provides the surface benefits of titanium while retaining the benefits associated with traditional PEEK-OPTIMA devices such as biocompatibility, modulus of elasticity similar to bone, and excellent radiographic visibility for post-op imaging.
“Surgeon response to our NanoMetalene family of implants has been overwhelmingly positive – in part because this technology offers the best features of titanium and PEEK in an interbody solution that we believe supports bone growth,” said Keith Valentine, CEO of SeaSpine. “We will continue to expand our NanoMetalene offering throughout 2016 and into 2017 to ensure this differentiated technology is available for all interbody spine procedures.”
With a curved, anatomically geometric shape, the Hollywood VI NanoMetalene implant is well-suited for placement in the anterior column of the spine. This variable insertion (VI) design facilitates final implant placement within the disc space and provides TLIF surgeons options tailored for their patients. Hollywood VI NanoMetalene also features a completely coated graft aperture for autogenous bone graft for fusion.
SeaSpine expects to launch additional NanoMetalene coated PEEK interbody devices in future periods. NanoMetalene and SeaSpine are registered trademarks of SeaSpine Orthopedics Corporation or its subsidiaries in the United States and/or other countries. Hollywood, Ventura, Cambria, and the SeaSpine logo are trademarks of SeaSpine Orthopedics Corporation or its subsidiaries. PEEK-OPTIMA is a registered trademark of Invibio and is used by SeaSpine under license.
For Further Information
More on the MIS interbody fusion market in in the United States can be found in a report suite published by iData Research entitled the U.S. Market for Minimally Invasive Spinal Implants. The suite covers reports on the following markets: Spinous Process Fixation, MIS Interbody Fusion, MIS Pedicle Screws, and MIS Sacroiliac Joint Fusion.
The iData report series on minimally invasive spinal implants covers the U.S., Australia, Japan, South Korea, China, Taiwan, Argentina, Brazil, Mexico, and 15 countries in Europe including Austria, Belgium, Denmark, Finland, France, Germany, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, the U.K., and Switzerland. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about MIS spinal implant market data or procedure data, register online or email us at [email protected] for a U.S. Market for Minimally Invasive Spinal Implants brochure and synopsis.
About Procedure Tracker
Procedure number data is available from iData’s Procedure Tracker service, which allows subscribers to define and analyze procedure data segmented by state, region, hospital, surgery centre, and physician. A customizable dashboard sorts procedure data for further analysis and research.
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iData Research’s Reimbursement Policy Tracker enables medical device, dental, pharmaceutical and healthcare professionals to receive real-time policy updates from hundreds of insurance companies and 60,000+ policies across all therapeutic areas in the United States.
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