Neurological Surgery Archives

NeuroVasx’s cPAX Aneurysm Treatment Gets Limited FDA Approval

by Smit Shah on Apr 6, 2011 •

ade34343 NeuroVasxs cPAX Aneurysm Treatment Gets Limited FDA Approval
The FDA has just approved NeuroVasx, Inc.’s cPAX Aneurysm Treatment System through the Humanitarian Device Exemption (HDE), which allows for treatment of up to 4,000 patients a year. The EU CE marked device, which we have covered previously here at Medgadget, can attain better filling of aneurysms than traditional metal coil treatments because it is composed of a relatively softer material.
From the announcement:

cPAX is a polymeric strand delivered into the aneurysm using a technique similar to currently available platinum coil technologies. cPAX, because of its soft polymeric material, is designed to achieve more complete filling of the aneurysm with the probable benefit of greater long term stability. A significant feature of cPAX in comparison to currently available technologies is that it offers the physician the ability to detach the device at any point versus a fixed detachment zone common in platinum coils. The polymeric material also allows for non-invasive CT and MRI scans with little or no artifact for more accurate patient follow-up assessment.

Press release: NeuroVasx Receives FDA Approval for cPAX Aneurysm Treatment System…
Flashback: NeuroVasx Gets CE Mark for cPAX Aneurysm System

Neurological Surgery

InterStim Sacral Nerve Stimulation for Bowel Control Is Now Option in US

by Gene Ostrovsky on Apr 5, 2011
InterStim Sacral Nerve Stimulation for Bowel Control Is Now Option in US

The FDA has issued Medtronic clearance to market the InterStim sacral nerve stimulation therapy system for people with chronic fecal incontinence. The pacemaker-like device has already been FDA cleared for urinary control and has shown an 80% success rate in improving bowel control in the latest study published in Annals of Surgery.

The implantable InterStim system uses mild electrical stimulation of the sacral nerves to influence the behavior of the pelvic floor muscles and bowel. As a result, the therapy significantly reduced fecal incontinent episodes for a high percentage of clinical trial patients. InterStim Therapy is the only bowel control treatment option that allows patients and physicians to determine probable success of the therapy through a test stimulation procedure prior to committing to long-term therapy.

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Neurological Surgery / Neurology

Jan Medical’s Sonar-based Brain Imaging System Might Rapidly Diagnose Ischemic Strokes

by Smit Shah on Mar 29, 2011
Jan Medical's Sonar-based Brain Imaging System Might Rapidly Diagnose Ischemic Strokes

Currently, when patients display the symptoms of an ischemic stroke, they have to go to a hospital for brain imaging before a proper diagnosis can be made. Jan Medical, Inc. claims that its new portable brain imaging system, based on a very interesting technology, will solve this problem by allowing doctors to quickly diagnose strokes in patients in the office or in those who are en route in an ambulance. What’s more is that the system can potentially be used for monitoring cerebral vasospasm in patients who suffered an intracranial bleed.
The company also hopes that the system’s portability will allow for continuous monitoring of stroke patients so doctors can follow their recovery once they leave the hospital. The Mountain View, CA based company plans to present clinical trial data validating its system’s efficacy in detecting strokes later this week at the annual scientific meeting of the Society of Interventional Radiology (SIR).

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Neurological Surgery / Orthopedic Surgery

Boston Scientific’s Clik Anchor for Faster, Easier SCS Lead Placements

by Gene Ostrovsky on Mar 24, 2011
Boston Scientific's Clik Anchor for Faster, Easier SCS Lead Placements

The U.S. Food and Drug Administration gave Boston Scientific approval for its new Clik Anchor technology, developed to provide a new way to secure leads of the Precision Plus Spinal Cord Stimulator system. The device, pictured on the side, is designed to make a click when a secure attachment is made.

The Clik Anchor features an innovative locking system designed to improve lead anchoring speed and consistency. Locking into place on the lead with a simple turn of a hex wrench, it provides tactile and audible confirmation for physicians that the lead is secured.

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Neurological Surgery / Radiology

Pipeline Embolization Device Gets FDA Panel Recommendation

by Gene Ostrovsky on Mar 22, 2011
Pipeline Embolization Device Gets FDA Panel Recommendation

The FDA’s Neurological Devices Advisory Panel has recommended approval of the Pipeline device for “endovascular treatment of large or giant wide-necked intracranial aneurysms in the cavernous and paraclinoid regions of the internal carotid artery.” The product, made by ev3, a Plymouth, MN company recently acquired by Covidien, already has EU’s CE Mark of approval.

Flow Re-Direction

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Neurological Surgery / Neurology / Oncology

NovoTTF System for Slowing Progression of GBM May Soon Be Available in U.S.

by Gene Ostrovsky on Mar 18, 2011
NovoTTF System for Slowing Progression of GBM May Soon Be Available in U.S.

Novocure, a subsidiary of Jersey Isle based Standen Ltd., just received a non-binding recommendation from an FDA panel regarding its NovoTTF system for glioblastoma multiforme. The panel’s position will weigh heavily on FDA’s final decision on whether to clear the device that delivers electric currents in an attempt to disrupt tumor cells prior to division.
From the press release:

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Neurological Surgery

Medtronic Announces Availability of Its Activa SC Deep Brain Stimulator

by Smit Shah on Mar 16, 2011
Medtronic Announces Availability of Its Activa SC Deep Brain Stimulator

Adding to its Activa line of deep brain stimulation (DBS) devices, Medtronic has announced the US and European launch of its new Activa SC DBS system. The new implant is a single-channel neurostimulator used to treat the symptoms of Parkinson’s disease, essential tremor, and dystonia.
From the press release:

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Neurological Surgery

Elana Device for Intracranial Artery Bypass Gets FDA Nod

by Gene Ostrovsky on Mar 14, 2011
Elana Device for Intracranial Artery Bypass Gets FDA Nod

Performing an artery bypass in the brain typically requires shutting off blood flow, potentially leading to a stroke in some patients. Based on a technology developed at UMC Utrecht, Elana, also out of Utrecht, The Netherlands, just received FDA Humanitarian Use Device approval for its commercialized product called ELANA (Excimer Laser Assisted Non-Occlusive Anastamosis) Surgical Kit, a tool that allows neurosurgeons to reroute blood flow around an aneurysm or a tumor without stopping the flow of blood.

To create the bypass, a surgeon sutures the ring and a section of replacement blood vessel onto the surface of the affected artery. Once attached, the surgeon tunnels the tip of the laser handpiece down the open end of the replacement blood vessel until the tip of the laser touches the ring.

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Neurological Surgery / Orthopedic Surgery

Medtronic’s VERTEX SELECT CHROMALOY Plus Rods

by Gene Ostrovsky on Mar 11, 2011
Medtronic's VERTEX SELECT CHROMALOY Plus Rods

Medtronic is making available in the U.S. its VERTEX SELECT CHROMALOY Plus Rods, optional variable size components to the VERTEX SELECT cervical spinal stabilizing system.

The VERTEX SELECT® CHROMALOY™ Plus Rod is a supplement to the VERTEX SELECT® Reconstruction System. During a procedure, a surgeon uses the rods to connect existing or new fusion systems in the patient’s occipitocervical and upper-thoracic spine. CHROMALOY™ Rods consist of cobalt chrome alloy material with engineered features, including a blend of three metals which, according to mechanical testing, help improve the rod’s biomechanical characteristics and maintain a more rigid overall construct. The VERTEX SELECT® Reconstruction System is intended to provide stabilization to promote fusion.

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