RoG Sports Medicine Achieves FDA Clearance for New Suture Anchor Implant Made of Solvay's Zeniva® PEEK |
Solvay Advanced Polymers, L.L.C.
4500 McGinnis Ferry Road
Alpharette, GA, 30005-3914
USA
Press release date: July 14, 2011
Versatile Biomaterial Brings Exceptional Performance and Lower Cost for Sports Medicine Procedures
ALPHARETTA, Ga. - RôG Sports Medicine Inc., Orland Park, Ill., an environmentally-focused start-up company which produces affordable, high-quality implants, has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its new RôG Suture Anchor made of Zeniva® polyetheretherketone (PEEK) resin from Solvay Advanced Polymers, LLC, a Solvay Specialty Polymers company. Zeniva PEEK - part of Solvay's line of Solviva® Biomaterials - 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 well-developed master access file for Zeniva PEEK.
The three suture anchors made from 6-mm diameter Zeniva PEEK rod stock are implants that aid in re-attaching soft tissue to bone. These implants are threaded so they screw into bone, thus securing the soft tissue to the prepared bone surface so that the soft tissue and bone re-unite.
These high-quality RôG suture anchors provide the surgeon with high strength and functional performance. They come in a range of sizes and variable diameters to maximize a surgeon's options to accommodate a patient's natural anatomy. The implants are widely used in many parts of the body where soft tissue and bone have been separated, resulting in pain and loss of motion.
"Zeniva PEEK provides not only the exceptional properties that are required of high-precision implants, but has lowered the barrier for a small company like ours to afford this high-tech material and help to lower the high price of health care," said Dr. Blair Rhode, president & CEO of RôG Sports Medicine. Dr. Rhode is also an owner of an out-patient surgery center and is determined to eliminate waste and change the way implants are distributed today.
RôG is solely focused on manufacturing high-quality implants and its sales and distribution will be handled by OrthoDirectUSA. "The cost of healthcare in the U.S. is not sustainable in its present form and the value stream needs to be re-defined," said Tommy Mitchell, president of OrthoDirectUSA. "The true cost of the implant is a small part of the selling cost and it is our mission to teach, train, and coach hospitals and surgery centers to take back this responsibility and reap the associated savings."
The cost of these implants will be 60% to 80% less than what facilities pay today for virtually the same implants, according to Mitchell. The direct access model eliminates the significant sales and marketing expense of the traditional orthopedic supply company today, he added.
Zeniva PEEK offers numerous advantages over metals such as titanium for these implantable devices. The material offers many important benefits including biocompatibility, chemical inertness, and a modulus of elasticity that is close to that of bone. It boasts high strength and stiffness and is totally radiolucent enabling the surgeon to clearly see the bone/soft tissue interface on x-rays without the shadows and opacity of titanium.
"We're excited about the commercial adoption of Zeniva PEEK for these very popular implants," said Judy Melville, global business development manager for Solviva® Biomaterials. "With an aging population and more active lifestyles, there is a growing demand for these procedures." The company has made significant investments and performed all applicable required testing to ensure that Zeniva PEEK meets or exceeds the critical regulatory and performance standards set by the FDA for this application.
Zeniva PEEK and the entire line of Solviva Biomaterials are manufactured in compliance with the relevant aspects of ISO 13485 and under the relevant aspects of 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 accredited lab that is ISO 17025 compliant. Solvay is currently in active product trials with several medical device manufacturers using Zeniva PEEK as well as other Solviva biomaterials.
In addition to Zeniva PEEK, the Solviva Biomaterials line includes Proniva® self-reinforced polyphenylene (SRP), one of the world's stiffest and strongest unreinforced thermoplastics that offer exceptional hardness and biocompatibility; Veriva® polyphenylsulfone (PPSU), which provides unsurpassed toughness combined with transparency and excellent biocompatibility; and Eviva® polysulfone (PSU), which offers practical toughness in a strong, transparent polymer.
About RôG Sports Medicine Inc.
RôG (pronounced Rogue) Sports Medicine Inc., based in Orland Park, Ill., is a supplier of sports medicine products using Zeniva polyetheretherketone (PEEK) resin from Solvay Advanced Polymers, LLC.
The company is dedicated to eliminating waste and improving efficiency to ensure that sports medicine products are affordable for all. The company's mission is to provide stable technology implants in the sports medicine market which are FDA approved, time tested, and high quality. The company believes that by providing transparency and focusing on excellent high-quality manufacturing it can make a significant contribution to reducing implant prices. For more information, call (708) 364-8441 or visit www.buyrog.com.
About OrthoDirectUSA Inc.
OrthoDirectUSA, based in Ft. Wayne, Ind., has established a new business model that connects hospitals and ambulatory surgery centers directly with the manufacturer. By eliminating various sales, marketing, and distribution costs, practitioners can save as much as 60% to 70% off the cost of implants and equipment. To facilitate this new supply chain, OrthoDirectUSA teaches, trains, and coaches personnel to take back the responsibility of managing orthopedic service. For more information, call (888) 600-4611 or visit www.orthodirectUSA.com.
About Solvay Specialty Polymers
Solvay Specialty Polymers is comprised of the activities of the Solvay Advanced Polymers, Solvay Solexis and Solvay Padanaplast companies along with the Ixan® and Diofan® PVDC product lines. As the manufacturer of more products with more performance than any other polymer company in the world, Solvay Specialty Polymers supplies over 1500 products across 33 brands of high-performance polymers - fluoropolymers, fluoroelastomers, fluorinated fluids, semi-aromatic polyamides, sulfone polymers, aromatic ultra polymers, high-barrier polymers and cross-linked high-performance compounds - for use in Aerospace, Alternative Energy, Automotive, Healthcare, Membranes, Oil & Gas, Packaging, Plumbing, Semiconductors, Wire & Cable, and other markets. Learn more at www.solvayspecialtypolymers.com.
Solvay is an international industrial Group active in Chemistry. It offers a broad range of products and solutions that contribute to improving quality of life. The Group is headquartered in Brussels and its companies employ 17,000 people in over 40 countries. In 2010, its consolidated sales amounted to EUR 7.1 billion. Solvay is listed on the NYSE Euronext stock exchange in Brussels (NYSE Euronext: SOLB.BE - Bloomberg: SOLB.BB - Reuters: SOLBt.BR). Details are available at www.solvay.com.
Press Contact:
Joseph Grande
413.684.2463
solvayap.press@solvay.com
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