Alphatec Receives Key Regulatory OKs
Alphatec Holdings Inc., the Carlsbad, Calif.-based parent company of Alphatec Spine Inc., has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for two new pipeline products: the Pegasus and the Illico FS facet fixation system.
Pegasus is an anterior cervical interbody device that reportedly offers single-step deployment of the anchoring blades without need for impaction. Illico is a minimally invasive surgical (MIS) system that enables spine surgeons to immobilize and stabilize spinal segments without the need for pedicle screw and rod constructs, according to the company.
In addition to FDA clearance, Alphatec has received approval in Japan from the Pharmaceuticals and Medical Devices Agency to market and sell three lines of the company’s Novel PEEK (polyetheretherketone) spinal spacers, including the Novel SD, the Novel LCC and the Novel TL, which are used in posterior spine fusion procedures. PEEK is a radiolucent material containing radiographic markers, which enhance interbody visualization and alignment during the fusion process.
“I am pleased to announce these important new developments related to our new product commercialization strategy at Alphatec Spine,” said Les Cross, chairman and CEO of Alphatec Spine. “Our initiatives to strengthen the top-line growth of the company through robust internal product development, acquisitions and license arrangements, and continued global expansion are gaining momentum. Our new Pegasus anchored cervical interbody device and Illico FS system represent key additions to our cervical and MIS offerings in the United States, respectively.”
Cross went on to say that the Japanese product registration process has been “long and complex,” and that the company is pleased to have achieved the milestone there for its spinal spacer systems.
Alphatec Spine makes products the surgical treatment of spine disorders, primarily focused on the aging spine.