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Vertiflex is building momentum with two recent device approvals.
San Clemente, Calif.-based Vertiflex Inc., a minimally invasive spine company, has sold what it terms “non-core” assets to Kalamazoo, Mich.-based Stryker Corporation. The terms of the deal were not disclosed. “The sale of these innovative assets to Stryker represents the beginning of a new era in our relationships with strategic partners,” said Earl R. Fender, president and CEO of VertiFlex. “The agreement with Stryker includes up-front cash, contingent payments as well as a long-term licensing agreement. I’m very proud of the Vertiflex team. In addition to enrolling the largest ever FDA (U.S. Food and Drug Administration) PMA (pre-market approval) trial of a device for spinal stenosis, we’ve also demonstrated proficiency in developing differentiated products for spinal therapies. The assets sold to Stryker are representative of such innovation.” In December last year, Vertiflex received FDA 510(k) clearance for its Superion interspinous spacer system. In November, it received clearance for its Totalis direct decompression system. The first surgery using Totalis was performed on March 1 by Eric Grigsby, M.D., at the Napa Surgery Center in Napa, Calif. The system consists of a set of surgical instruments designed specifically for performing minimally invasive direct decompressions of the lumbar spine. Totalis includes both reusable and disposable instruments to treat spinal conditions such as lumbar stenosis. The procedure involves a small single midline incision and sequential dilation to a working cannula about the size of a dime. Instruments designed for precision and safety are then used to remove the targeted tissue. According to Vertiflex, the procedure provides physicians the ability to remove ligament, bone, and facet capsule material to address both central and lateral recess stenosis. This broad decompression involves minimal collateral tissue disruption and can be performed under local anesthesia. “One of our biggest challenges in treating spinal stenosis is removal of the ligament which causes narrowing of the spinal canal, without further destabilizing the spine,” explained Grigsby. “The Totalis system allows a more thorough resection of the offending ligament than other minimally invasive options, and still leaves the structural elements of the lumbar spine intact. It’s a very significant advancement in the treatment of spinal stenosis, and the evolution of minimally invasive spinal surgery overall.” “For patients, it means the likelihood of greater pain relief and faster recovery,” added Fender. Company officials said Vertiflex planned to use the cash that it received from Stryker, which has annual sales of $8.6 billion and a recent market value of about $25.2 billion, toward further development and commercialization of its devices that treat lumbar spinal stenosis, or a narrowing of the spinal canal. Stryker has been experiencing growth in its spine sector. In the fourth quarter of 2012, the company’s spine business brought in $190 million, a 6.4 percent increase over the same quarter in 2011.
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