K2M, Inc. has announced the launch of the TERRA NOVA^® Minimally Invasive Access System and the SERENGETI^® Disposable Kit at the North American Spine Society (NASS) 2009 Annual Conference. TERRA NOVA is a minimally invasive spine-based access system used in conjunction with K2M’s revolutionary SERENGETI percutaneous retractor. TERRA NOVA has the potential to minimize tissue disruption by utilizing a small incision and muscle splitting technique.

Integra LifeSciences has announced that it is featuring the Paramount(R) Pedicle Screw Fixation System for minimally invasive spine surgery at the annual North American Spine Society (NASS) Meeting, in San Francisco, California. Integra acquired the Paramount(R) system in September 2009 as a result of the acquisition of certain assets of Innovative Spinal Technologies, Inc. The Paramount(R) System will be made available to a select group of surgeons, following the introduction at NASS.

Covidien plc received the FDA approval for the use of its tissue sealant product DuraSeal for use during spine surgery. Covidien expects to start selling DuraSeal for spinal use within a few weeks. The product has been on the market since 2005 for use during brain surgery. “DuraSeal continues Covidien’s dedication to scientific, evidence-based innovation that improves patient outcomes,” Dr. Michael Tarnoff, chief medical affairs officer for Covidien’s surgical devices unit, said in a statement.

A research conducted by a team from Brigham and Women’s Hospital (BWH) indicated that bone-morphogenetic protein (BMP), used in 25% of spinal fusion surgeries, lead to a higher rate of complications in certain types of fusions as well as greater hospital charges, as compared to fusions that do not use BMP. The primary increase was seen in wound-related complications and dysphagia or hoarseness.

Researchers at Brigham & Women’s Hospital have found that complications caused by some bone-growth products, used in spinal fusion surgery, increase hospital stays and costs between 11% and 41%. The research conducted by a team of scientists and published in the “Journal of the American Medical Association” studied Medtronic Incorporated’s “InFuse” and Stryker Corporation’s “OP-1 Implant” and “OP-1 Putty” products.

The National Institute for Health and Clinical Excellence has issued a guidance which recommends the availability of Spinal Cord Stimulation (SCS) to all patients suffering from chronic neurologic pain for a minimum of 6 months after note benefiting from conventional treatment for pain management. Before implantation, the patients would go through a trial of the treatment. The guidance is a ray of hope for patients with Failed Back Surgery Syndrome (FBSS). In this therapy, electric pulses are sent to electrodes attached to a fully implanted neurostimulator battery. They interrupt the pain messages sent to the brain.

The U.S. Food and Drug Administration has cleared US Spine’s Preference 2 Complex Spine System™ for use in the United States. With this approval, US Spine makes an entry into the deformity and trauma market. Designed by some of the leading spine surgeons for the treatment of complex spinal conditions, the system is featured by a number of new components that include hooks, screws and rods. The anchoring implants in the system are featured by Helical Flange® Closure mechanism that reduces cross threading drastically and eliminates head splay.

The European Commission has granted orphan drug designation to Cethrin developed by Alseres Pharmaceuticals, Inc., for the treatment of traumatic spinal cord injury (SCI). The drug had received the same status from FDA in 2005. Currently being tested for restoration of sensory and motor function, Cethrin is in Phase-II of its clinical trial.
The designation provides the drug with market exclusivity for a period of 10 years in the EU (7 years in the U.S). The Commission considered SCI as one of the rare and critical conditions lacking effective therapies.

DePuy Spine Inc., a Johnson & Johnson company, has launched a new minimally invasive spine system called the VIPER™2 Pedicle Screw Fixation System (VIPER2). The system offers comprehensive instrumentation and implant options that can be used on a wide range of spinal pathologies including deformity, trauma, tumor and degenerative disc disease. VIPER2 is the first and only complete minimally invasive rod and pedicle screw system that can be used to perform minimally invasive spinal fixation across the length of the entire thoracolumbar spine (T1 to Pelvis), with rods of any curvature and lengths from 30 to 480 mm.

Researchers at Northwestern University have come up with a nano-engineered gel that has been shown to curb the formation of scar tissue at the site of spinal injuries, thereby allowing the spinal chord fibers to regenerate. The gel has to be injected into the spinal chord as a liquid, which then turns into a scaffold, supporting the new nerve fibers.