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Product News

News about neurosurgical products are presented here.

PentaFirst Five-Column Neurostimulation for Spinal Cord Stimulation

St Jude Medical has announced FDA approval for the new Penta(TM) surgical lead - featuring the smallest electrodes on the market arranged in five columns. The lead is used for spinal cord stimulation managing chronic pain of the trunk, limbs and back.

According to the press release, the new surgical lead can more specifically focus current over a greater lateral area of the spinal cord. 

It offers the broadest lateral electrode span of the neurostimulation leads on the market and the paddle configuration is 10.9 mm wide.

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DuraSeal2.jpgFDA approval of DuraSeal Spine Sealant

Covidien announces that it obtained FDA approval for the DuraSeal™ Spine Sealant, which is a synthetic hydrogel for intra-operative sealing of the dural membrane during spine procedures.

Covidien refers to a prospective, multi-center, randomized controlled study by Wright et al presented at the Congress of Neurological Surgeons meeting 2009. 158 patients undergoing spinal surgery were divided in 2 groups – 102 patients received DuraSeal Sealant and 56 received standard care. Patients treated with DuraSeal had higher rate of watertight closure with initial treatment.

However, no significant difference was seen in post-operative fluid leaks or infection.


Wright NM. DuraSeal™ spine sealant as an adjunct to standard dural repair: results of a prospective multicenter, randomized study. Abstract #928, 2009 Congress of NeuroSurgeons.
It is possible to view the poster using the following link:
http://2009.cns.org/posterbrowser.aspx . Use the name DuraSeal as Title to find the poster.

Link to Covidien with product info: http://www.durasealspine.com/durasealspine

CobbMeter.jpgA French ortopedic surgeon, Frederic P Jacquot, has developed CobbMeter, an application which turns the iPhone into a professional measuring tool.

It is designed to measure the Cobb angle, the kyphosis angel, and the sacral slope on vertical spine radiographs.

All that one has to do in using the device is align the side of the iPhone to the standard tracings we use routinely, and the position sensor built in the iPhone will do the rest.

The precision of the device itself is 1/10th of a degree

Measures are logged for further use and may be sent by e-mail to the surgeon or staff for recording purposes, with the levels of the measured curve, type of curve and patient id or number. A calibration procedure was also implemented to accurately measure the angle with the horizontal plane as in the sacral slope.

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Implantable Epilepsy Device in Initial Clinical Studyrns-implant.jpg

An implantable epilepsy device from NeuroPace Inc is currently tested in a randomized, double-blind, sham stimulation controlled investigation at approximately 28 sites throughout the United States. The RNS-device is designed to detect abnormal electrical activity in the brain and to deliver small amounts of electrical stimulation to suppress seizures before there are any seizure symptoms.

The RNS is placed within the skull and underneath the scalp. The RNS is then connected to one or two wires containing electrodes that are placed within the brain or rest on the brain surface in the area of the seizure focus (where seizures start). The RNS is designed to continuously monitor brain electrical activity from the electrodes and, after identifying the "signature" of a seizure's onset, deliver brief and mild electrical stimulation with the intention of suppressing the seizure. This type of treatment is called responsive stimulation, but it is not yet known if it will work for the treatment of epilepsy.

A modified laptop computer known as a programmer communicates with the RNS via a hand-held wand. The programmer collects information from the RNS about brain electrical activity and is used to program the RNS to make detections and deliver responsive stimulation.

The purpose of the RNS System Pivotal Clinical Investigation is to assess the safety and to demonstrate that the RNS System is effective as an add-on (adjunctive) therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures (those that start from one or two areas of the brain) that are refractory (resistant or hard to treat) to two or more antiepileptic medications. Participants in the trial will continue to receive their epilepsy medications.

Read more:
NeuroPace website 
Singularity Hub 
Videoclip from KGO-TV.com  

Medtronic_NerveNew Intraoperative Nerve Integrity Monitors

Medtronic has launched of a couple new intraoperative nerve integrity monitors. The NIM-Response® 3.0 and NIM-Neuro® 3.0 help locate critical nerves during surgery and monitor their integrity throughout the procedure.

According to the press release from Medtronic the The Nim 3.0 systems enables simultaneous monitoring during bipolar cautery, includes artifact detection software that distinguishes artifacts (false signals) from true nerve signals, stim Bur technology that combines stimulation with Medtronic’s electric Visao® High-Speed Otologic Drill and real-time continuous monitoring of nerve function via APS™ (Automatic Periodic Stimulation)* that provides early warning of a change in nerve function.

Read more in Press release

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