Chalk up another victory for polyetheretherketone (PEEK) in the metal replacement sweepstakes. Thompson MIS (Salem, NH), a supplier of minimally invasive spinal implants and delivery systems, has received 510(k) clearance from FDA for its BoneBac TLIF spacer made of Zeniva PEEK resin from Solvay Specialty Polymers (Alpharetta, GA). Solvay made the announcement at the North American Spine Society's annual meeting last week in San Francisco.

All of Solvay's Solviva biomaterials are available in injection molding and extrusion grades as well as rods and plates for machined components.

Thomas A. Dee, SVHC’s president and CEO, concluded: “This is a great example of how collaboration and innovation sustain us during challenging times.

Part of Solvay's Solviva line of biomaterials, Zeniva PEEK has a modulus very close to that of bone plus excellent toughness and fatigue resistance. The FDA clearance was based, in part, on Solvay's master access file for the material, according to the company.

The BoneBac TLIF spacer is a transforaminal lumbar interbody fusion spacer. These spacers are implanted in the lumbar disc space to enable fusion of the adjacent bony surfaces of the vertebrae. Minimally invasive surgery is made easier with this spacer thanks to its patented geometry that allows for direct injection of graft while the inserter is still attached, resulting in a more complete fill when packing the disc space. The BoneBac TLIF spacer also provides surgeons with two options for implant insertion.

Together, Mack and SVHC began investigating alternative mask options that could be modified due to the high demand for N95s masks and 7700 respirators.

Zeniva PEEK is a comparable alternative to metals such as titanium for these intervertebral implantable devices, according to Thompson MIS. The material offers many important benefits including biocompatibility and chemical inertness. Based on biocompatibility testing, Zeniva PEEK demonstrates no evidence of cytotoxicity, sensitization, irritation, or acute systemic toxicity. The material meets the ASTM F2026 standard, which provides the requirements and associated test methods for PEEK in virgin form used in the manufacture of intracorporeal devices. The material also boasts high strength and stiffness and has radiolucent properties that enable x-ray procedures without interference.

“As an essential manufacturer of healthcare products, I knew that they would want to help and came through with a brilliant solution for us.”

Adam Lehman, president of Mack’s Woodbridge, Conn., subsidiary, Synectic, worked quickly to identify available options that could be redesigned to function as a respirator, and Lehman located a snorkelling mask that the Synectic design team could quickly re-engineer into PPE.

Following two weeks of design, testing, and manufacturing, Mack’s team at Synectic fabricated an attachment to a snorkelling scuba mask. The mask covers the entire face and removes the need for disposable masks and shields. To create the masks, Mack’s engineers removed the part that usually protrudes out of the water when snorkelling, and replaced it with a new, custom-designed branched component equipped with cartridges containing P100 HEPA filters.

Jeff Somple, president at Mack headquarters in nearby Arlington, VT said: “When I informed Synectic’s team about this project, they were ready and excited for the challenge.

Thompson MIS uses Zeniva PEEK rod stock and performs high-precision machining to produce a full range of sizes and configurations.

The manufacturing site for Zeniva PEEK and other Solviva biomaterials in Alpharetta is certified to ISO 13485, the international standard for quality systems in the design and manufacture of medical devices, and follows current Good Manufacturing Practices. Solvay's biomaterial manufacturing processes are carefully validated and enhanced controls provide product traceability. In addition, all materials are tested in an ISO 17025 accredited lab.

Before being assigned a mask, each SVHC staff member is “fit tested” to ensure an adequate seal. Each employee also receives cleaning and storage guidelines with instructions on how to disinfect and store the masks after each shift. Additionally, before each use, staff conduct a positive and negative pressure test to ensure the masks are holding up for their protection. The fact that the air intake is above the wearer’s head improves the line of site and allows patients to see their physicians’ and nurses’ faces more clearly.

Dailey commented: “Mack has always been a tremendous regional partner and an integral supporter of the health system for many years.

"We're excited about the commercial success of Zeniva PEEK in the spinal fusion market," said Shawn Shorrock, Global Director of Regulatory Affairs for Solvay Specialty Polymers' healthcare business in a prepared statement. "The ongoing acceptance of Zeniva PEEK has validated our approach to the spinal market, and we're encouraged by the momentum we've generated."

“It was an opportunity for some ground-breaking innovation and to make a meaningful difference for our region’s front line healthcare workers.”

Unlike medically approved respirators, the scuba mask has been adapted to meet the filtration requirements of PPE. The risk assessment conducted by Mack’s design and SVHC showed that the mask fully seals around the face with silicone - reducing skin breakdown, and the N100 HEPA filters have a higher rate of filtration than the material in the traditional N95 masks. Less than three weeks after the initial request to Mack, its subsidiary Synectic delivered 500 scuba masks and 2,000 N100 HEPA filter casings to the hospital.

Chalk up another victory for polyetheretherketone (PEEK) in the metal replacement sweepstakes. Thompson MIS (Salem, NH), a supplier of minimally invasive spinal implants and delivery systems, has received 510(k) clearance from FDA for its BoneBac TLIF spacer made of Zeniva PEEK resin from Solvay Specialty Polymers (Alpharetta, GA). Solvay made the announcement at the North American Spine Society's annual meeting last week in San Francisco.

"Our gratitude for the hardworking teams at Mack and Synectic, who put many long hours into this project, cannot be overstated. This is another wonderful example of Mack’s continued support of SVHC.”

Shiela Boni, a nursing director and PPE officer for SVHC added: “Our priority is to ensure the safety of our staff while caring for patients during the pandemic.

The collaboration arose because Kevin Dailey, the vice president of administration/CHRO at SVHC had led human resources at Mack until five years ago. Dailey called Mack to help with the PPE.