More spine news from NASS as K2M Group Holdings, Inc., announces the introduction of its proprietary Lamellar Titanium Technology™. The system draws on 3D printing with the goal of allowing for bony integration throughout an implant.
Background
When it comes to spinal implants the casual observer doesn’t have to read many news releases this year to realise that the starting point seems to be a claim about surface texture. With the right surface, the evidence suggests the implant will integrate better, be more stable and secure in situ and consequently optimise the surgical outcome.
K2M’s approach, which it’s calling Lamellar Titanium Technology, uses an advanced 3D printing method to create structures that were once considered impractical with traditional manufacturing techniques. That in itself is undeniably clever. Starting with a titanium powder, the implants are grown through the selective application of a high-energy laser beam, allowing for the incorporation of both a porosity and surface roughness that pre-clinical data have associated with bone growth activity, says a company press release.
With a surface roughness of 3–5 microns, K2M’s Lamellar Titanium Technology is designed to allow for direct bony “ongrowth”. This surface roughness has been shown, in peer-reviewed research and pre-clinical data, to increase osteoblastic activity compared to smooth titanium and other biomaterials, such as PEEK.
K2M’s Lamellar Titanium Technology incorporates 500 micron diameter pores that run through the walls of the implant, forming continuous channels from endplate to endplate to serve as a conduit for bony integration. This feature taps into research suggesting that interconnected pores in the diametrical range of 300–700 microns are ideal for allowing bone ingrowth through porous biomaterials.
The first products to feature K2M’s Lamellar Titanium Technology are the CASCADIA™ AN and TL Interbody Systems, for which it recently received U.S. FDA 510(k) clearance and a CE Mark.
Physician comments
“With 3D printed Lamellar Titanium Technology, an innovative alternative to many traditionally manufactured PEEK and titanium designs now exists in the interbody space,” said Tom Morrison, MD, a neurosurgeon at Polaris Spine & Neurosurgery Center in Atlanta, Georgia. “I’m excited about the CASCADIA platform because it provides a balance of roughness and porosity that may allow the bone to grow into the implant.”
Company comments
“We are extremely excited to introduce Lamellar Titanium Technology, our new and proprietary technology that uses 3D printing,” said Eric Major, K2M’s President and CEO. “Because of this breakthrough technology, CASCADIA is an important addition to the interbody fusion market and strengthens our portfolio of products. These latest developments, coupled with the recent introduction of several complex spine offerings, reflect another strong year of innovation for K2M.”
Source: Globe Newswire
published: October 14, 2015 in: Approval/Clearance, Congresses and Meetings, Launches / Withdrawals, Spine