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Product is designed for use as an adjunct to fusion.
August 12, 2015
By: Michael Barbella
Managing Editor
SeaSpine Holdings Corporation has officially launched its Ventura NanoMetalene transforaminal intervertebral body fusion device. Ventura NanoMetalene, which is commercially available and has been successfully implanted, is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD). It is the latest device to leverage SeaSpine’s proprietary NanoMetalene technology, building on the surgical success of the company’s Hollywood NanoMetalene interbody device. NanoMetalene is an ultra-thin layer of commercially pure titanium molecularly bonded to a PEEK-Optima implant, according to the company. It is applied in a proprietary high-energy, low-temperature surface process and encompasses the entire implant, including the center graft window. This creates a 62 percent increase in surface area for potential titanium and bone interaction compared to the same implant with coated endplates only1. NanoMetalene offers the benefits associated with traditional PEEK-Optima devices such as a modulus of elasticity similar to bone2 and does not impair postoperative imaging, allowing surgeons to view the operative area and determine the extent of fusion of the vertebral bodies3. The ultra-thin layer of NanoMetalene upholds the similar mechanical profile of its PEEK-Optima core2. “We collaborated with our surgeon partners to create an implant that utilizes existing instrumentation and addresses today’s increasingly complex spinal surgery requirements,” said Keith Valentine, CEO of SeaSpine. “NanoMetalene technology is a great bridge product in our portfolio because it offers the benefits of hardware with biologic-driven features that support bone growth. Its success to-date supports our plan to develop additional implants leveraging NanoMetalene technology in the future.” With convex surfaces and multiple footprints, surgeons can create a secure anatomical fit, and Ventura NanoMetalene’s large graft aperture for autogenous bone graft assists in fusion, SeaSpine executives noted in a news release. Ventura NanoMetalene is optimal for either open or minimally transforaminal lumbar intervertebral fusion procedures. SeaSpine has received U.S. Food and Drug Administration 510(k) clearance for a number of other NanoMetalene coated PEEK interbody devices in its current portfolio and expects to launch these additional products in future periods. SeaSpine designs, develops and commercializes spinal treatment devices. References: 1. Results of imaging study. Data on file. 2. Data on file. 3. Area percentages are calculated comparing the implant endplates vs. entire implant of the smallest Ventura implant.
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