Medtronic (NYSE:MDT) said today it launched the CD Horizon Solera Voyager spinal system designed for minimally invasive spine procedures. The announcement was made at the 22nd annual International Meeting on Advanced Spine Techniques in Kuala Lumpur, Malaysia. The Horizon Solera Voyager offers multiple minimally invasive rod insertion options for transforaminal lumbar interbody fusion procedures, the Fridley, Minn.-based […]
Spine
InVivo shares jump on study results
InVivo Therapeutics (OTC:NVIV) shares jumped 10% today after the company released promising data on the 2nd and 3rd patients implanted with its investigational neuro-spinal scaffold. A 1-month checkup of the 3rd patient implanted with the scaffold reported an improvement from an A class injury on the American Spinal Injury Association Impairment Scale, indicating complete loss of […]
Integra LifeSciences closes SeaSpine spinout
SeaSpine Holdings (NSDQ:SPNE) closed its spinout from Integra LifeSciences (NSDQ:IART) and began trading today on the NASDAQ exchange. Plainsboro, N.J.-based Integra revealed its plan to shed the spine business last November, saying it planned for SeaSpine to become a stand-alone, publicly traded company to focus on its surgical solutions, orthopedics and tissue technology businesses. Integra acquired Vista, […]
SpineGuard wins clearance for Pediguard in China
SpineGuard (EPA:ALSGD) said today that it received Chinese clearance to sell its Pediguard, a handheld surgical device designed to help guide proper spine screw placement. The spine market in China is the 2nd-largest behind the U.S., the Vincennes, France-based company said, and is projected to be worth more than $1 billion by 2019. “This regulatory clearance […]
Centinel Spine claims 1st multi-level cervical indication
Centinel Spine today claimed it won the 1st multi-level indication for an interbody fusion device in the cervical spine, saying the FDA OK’d its Stalif C and Stalif C-Ti devices for then procedures. “This is a valuable indication given the high incidence of multilevel degenerative disc disease in the cervical spine. We are excited to be the 1st company to receive […]
MCRA touts aid to Vertiflex in Superion PMA
Musculoskeletal Clinical Regulatory Advisers said Wednesday it aided VertiFlex in winning pre-market approval from the FDA for its Superion interspinous spacer. The neuro-musculoskeletal and orthopedic advising and research organization said its assistance to Vertiflex helped reduce the average 26-month PMA review period to only 14 months. The Superion approval, won in May, marks the 1st spinal […]
Amendia acquires SpineSelect assets
Amendia Inc. said yesterday that it acquired the minimally-invasive transforaminal lumbar interbody fusion system assets from SpineSelect. The system assets purchased by Amendia include 2 product families – the Marquise MIS channel system and the Turbo MIS TLIF system, the Marietta, Ga.-based company said. “The addition of SpineSelect’s MITLIF system allows Amendia to offer another superior […]
B. Braun’s Aesculap wins FDA nod for lumbar disc
B. Braun Medical subsidiary Aesculap said today that it won FDA approval for its ActivL artificial disc indicated for the treatment of 1-level lumbar degenerative disc disease. The ActivL is designed as an alternative to spinal fusion surgery, the Center Valley, Pa.-based company said, and is the 1st lumbar disc with a mobile ultra high molecular […]
Boston Scientific touts positive data from next-gen SCS
Boston Scientific (NYSE:BSX) said yesterday that data from its Precision Spectra spinal cord stimulator study showed 1.5 times better pain relief and 2 times better lower back pain relief than its previous generation SCS. The analysis examined 213 patients treated with the new Precision Spectra and 130 patients treated with the previous generation Precision Plus, as well as 25 patients […]
St. Jude Medical touts early results for Axium neurostim device
St. Jude Medical (NYSE:STJ) said Monday that a study of its Axium dorsal root ganglion neurostimulator showed superior pain relief compared to traditional spinal cord stimulation in treating chronic lower limb pain associated with complex regional pain syndrome. The the 152-patient Accurate study reported that 81.2% of patients treated with the Axium system achieved significant pain […]
Stimwave wins nod from FDA for IDE trial
Stimwave Technologies said yesterday it won FDA investigational device exemption clearance to test an 8-electrode version of its wireless miniature neurostimulator device for the relief of chronic back and leg pain. Miami, Fl.-based Stimwave said the FDA also approved a study of the device using high frequency treatments through an external pulse generator. “This study […]