A Medical Device Daily

K2M (Leesburg, Virginia) the spinal device company developing innovative solutions for the treatment of complex spinal pathologies, reported the opening of a direct sales and distribution office in the UK. K2M's expansion into the UK began in 2008 with the CE mark clearance and successful introduction of its Range Spinal System, Mesa Spinal System, Denal Spinal System, Pyrenees Cervical Plate System, and Aleutian Interbody Systems.

"Setting up a European base is a clear statement that we are committed to expanding the availability of our innovative technology globally and supporting surgeons treating the most difficult spinal deformities," stated Christian Johnson, K2M's European VP. "Our mission is to be the worldwide leader in providing solutions for complex spinal pathologies and this is a huge step in the right direction."

"K2M's international expansion continues to gain momentum and the direct distribution of our products in the UK marks a critical milestone," stated Eric Major, K2M's president/CEO. "We are dedicated to developing a global company that recognizes the unique spinal instrument needs of different regions of the world and provides surgeons with techniques and technologies that will enhance their ability to treat all spinal patients."

Medtronic gains CE mark for PoleStar MRI

This week at the annual Congress of Neurological Surgeons, Medtronic (Minneapolis) reported the CE mark and international launch of the PoleStar N30 Surgical MRI system, the latest in neuro oncology surgical solutions. The PoleStar N30 System has been submitted to the FDA for approval.

Providing real-time imaging in the operating room (OR), the PoleStar Surgical MRI provides surgeons with targeting and navigational accuracy despite the anatomy movement that may occur during a procedure. With intra-operative imaging information, neurosurgeons have more confidence to achieve maximum tumor resection, while avoiding critical areas of the brain. Use of the PoleStar system may also reduce the need for revision surgeries and the length of stay at the hospital for the patient.

More than 50 PoleStar systems have been installed in ORs worldwide since 2001. The launch of the PoleStar N30 is the culmination of six years of research and development by Medtronic scientists and engineers working with surgeon customers from leading hospitals and clinics.

DSM develops VitroStealth coating

DSM Biomedical (Geleen, the Netherlands) reported development of VitroStealth, a non-biofouling (NBF) coating technology. Specifically developed to combine state of the art non-biofouling properties with high durability and fast processing, VitroStealth coating is scratch resistant and reduces unwanted protein absorption and cellular adhesion on surfaces.

To develop the medical coating technology, DSM Biomedical leveraged advances in scratch resistant coatings developed by its parent organization DSM for use in displays and other non-medical applications.

By extending DSM's leading hard coat technology to medical applications, DSM is aiming to offer the medical device and pharmaceutical industry the ability to decrease the likelihood of surface contamination and improve assay sensitivity, reproducibility and ultimately the reliability of medical consumables and point of care diagnostic tools. Application includes pre-analytical blood collection devices where VitroStealth coating eliminates surface mediated hemolysis and leads to clean, reproducible and thus reliable serum or plasma samples for the clinical laboratory. In diagnostics, VitroStealth coating increases signal to noise ratio as the analyte is not partially lost by adsorption to the surface of the device.

Furthermore, due to its highly hydrophilic character the coating increases the capillary flow of analytes in micro-fluidic point of care devices.

NeoChord begins European clinical trial

NeoChord (Minneapolis) a venture-backed medical technology company, reported that it has enrolled the first patient in its European clinical trial. The trial, known as TACT (transapical artificial chordae tendineae) is being conducted in Germany, Denmark, Czech Republic and Norway.

Intra-operative transesophageal echocardiography (TEE) confirmed that the patient's severe, eccentric mitral regurgitation was reduced to zero or trace mitral regurgitation. Giovanni Speziali, MD, the cardiac surgeon who is the primary inventor of the NeoChord device also attended the procedure. "These results, although early, are equivalent to what we obtain in traditional open heart surgery for correction of mitral regurgitation," said Speziali.

The NeoChord procedure was developed to treat sub-valvular chordal damage – the primary cause of degenerative mitral regurgitation – via minimally invasive implantation of artificial chordae tendineae. The technology was developed by Speziali and other doctors at the Mayo Clinic (Rochester, Minnesota) and exclusively licensed to NeoChord.