SpineSmith Partners’ VisuALIF

The VisuALIF interbody fusion implant system gained 510(k) clearance, SpineSmith announced Oct. 7. The device, which will be commercially available in November, was featured at the North American Spine Society (NASS) meeting in Orlando, Fla., Oct. 5-9. The VisuALIF system is a two piece system indicated for intervertebral body fusion of the lumbar spine.

Synapse Biomedical’s NeuRx DPS

The company says it expects FDA approval by next June for its NeuRx diaphragm pacing system (DPS) for use in amyotrophic lateral sclerosis (ALS) patients after applying for a humanitarian device exemption application Oct. 8. In ALS patients, the NeuRx DPS provides electrical stimulation to the diaphragm muscles, causing contractions that mimic natural breathing. The NeuRx DPS was granted an HDE in June 2008 for use in certain spinal cord injury patients and received a CE mark in Europe in 2007 for treating diaphragm dysfunction. (See “ Also see "Synapse Biomedical Debuts Diaphragm Pacer, HDE-Cleared To Aid Breathing" - Medtech Insight, 23 June, 2008. ” – “The Gray Sheet” June 23, 2008.)

Pharmaxis’ Aridol

The pharmaceutical company announced new drug approval for its Aridol bronchial challenge test kit through FDA’s pulmonary division Oct. 5. The company expects to launch the test kit in the first quarter of 2011 to test asthma. The Aridol test requires patients to inhale doses of dry powder mannitol from a hand-held device, which causes the airway to narrow and contract when airway inflammation is present. The lower the dose required to cause bronchoconstriction, the more serious the condition. The test kit is approved in 19 countries and is the only FDA-approved dry powder bronchial challenge test in the U.S., the company notes.

K2M’s Vikos and Ravine

The spinal device company announced Oct. 1 the launch of the Vikos cervical allograft system on a limited basis in the U.S., representing K2M’s entry into the biologics market. The Vikos system is a minimally manipulated human tissue and does not require FDA market approval. The system will support treatment of cervical pathologies with cortical ring and cortical-cancellous implant options in a range of sizes. K2M partnered with LifeNet Health to produce the allograft implants. Additionally, K2M announced it will launch its 510(k)-exempt Ravine lateral access system in the U.S. this quarter. The device’s dual flat blade platform differs from the traditional tubular retractors and fixates directly to the spine. K2M featured the device at the NASS meeting earlier this month.

GI Dynamics’ EndoBarrier

The company will begin shipments of its EndoBarrier , a non-surgical treatment for type 2 diabetes and obesity, in the United Kingdom in the next few weeks. GI Dynamics signed a limited agreement in September with Elemental Healthcare to distribute the device in the U.K. The firm gained a CE mark for 12 months of treatment with the EndoBarrier, announced Oct. 15. GI Dynamics previously received a CE mark for three and six months of treatment with EndoBarrier. The firm completed its U.S. clinical trials in November 2008 and is working with the FDA on the regulatory process, but will not disclose the time frame for PMA submission. The device is placed in the gastrointestinal tract endoscopically and creates a barrier between food and the wall of the intestine. Clinical trials with the device in over 300 patients have shown significant weight loss and diabetes improvement, the company says.

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