N2 Biomedical, a leading provider of coating and surface treatment solutions to the medical device industry, announced that the first PEEK interbody fusion device coated with the company's thin titanium coating technology was successfully implanted in a patient.
The coated device had previously received 510(k) clearance from the U.S. FDA. N2 Biomedical's thin titanium coating, which is a member of the company's NanoTitanium family of coatings, is less than a micrometer thick and is deposited using an advanced vacuum coating technology known as Ion Beam Assisted Deposition (IBAD), a process which combines evaporation with concurrent ion bombardment to provide unparalleled coating adhesion and control over properties such as surface morphology and coating density. The coating process has been fully validated, and N2 Biomedical has a Master File available for reference at the FDA.
"We are very excited to see our titanium coating utilized for the first time in a clinical application,” says Eric Tobin, CEO of N2 Biomedical. “This is the culmination of a significant effort made by numerous individuals both at N2 and the device manufacturer.”
Tobin says PEEK spinal interbody devices are an ideal application for this coating, and its clinical utilization supports N2's core mission of enhancing performance of our customers' devices with advanced technology.
“Our coatings have a wide array of uses in orthopedic and spinal devices,” Tobin says. “We look forward to further expanding application of these coatings in a range of surgical procedures."
PEEK is frequently used to fabricate orthopedic and spinal devices, in part due to its chemical inertness, radiolucency, and an elastic modulus that is closely matched to natural bone. However, PEEK surfaces provide relatively poor bone tissue attachment compared to titanium-based devices, which can reduce the probability of a successful fusion. Numerous scientific studies have shown that titanium coatings on PEEK can promote and increase new bone growth and result in stronger bone attachment. However, recent studies have also shown that the thicker thermal plasma spray (TPS) titanium coatings commonly used on PEEK implants can liberate titanium particles upon impaction, leading to complications such a phagocytosis.
To overcome the drawbacks of thick porous titanium coatings, there is growing interest in very thin (about 1 micron or less) titanium coatings on PEEK-based devices deposited using atomic-level deposition techniques such as IBAD, rather than through bonding or agglomeration of large titanium particles at high temperature. N2 Biomedical's thin titanium coating provides these advantages while passing all of the requisite standardized mechanical adhesion and durability tests including ASTM F1147, "Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings," ASTM F1044, "Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings," and ASTM F1978, "Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser."
About N2 Biomedical
Established in 2013, N2 provides coating and surface treatment development and application services for implantable and other medical devices utilized in orthopedic, cardiovascular, and other healthcare end-markets. N2 is ISO-13485 certified, FDA GMP-compliant, and operates in a 30,000 square foot facility with laboratory, manufacturing, and cleanroom space to service all customer and regulatory requirements. The company leverages its proprietary processes and equipment to provide customized solutions that enhance the characteristics of various materials in critical applications, including lubricity, infection resistance, biocompatibility and tissue integration, and wear and corrosion resistance. Additional information about N2 Biomedical is available at www.N2bio.com. N2 Biomedical is a portfolio company of Ampersand Capital Partners, a middle market private equity firm with more than $2 billion of assets under management dedicated to growth-oriented investments in the healthcare sector.
