Medical Product Guide» Neurology Products

Codman Launches Softest Endovascular Finishing Coil Designed To Seek And Fill Open Spaces In Cerebral Aneurysms

Jim Marino — Fri, 13 Aug 2010 09:26:27 +0000

Codman & Shurtleff, Inc. has announced the launch of the stretch resistant XTRASOFT™ ORBIT GALAXY™ Coil (XTRASOFT), the softest endovascular finishing coil1 for use in the treatment of cerebral aneurysms. XTRASOFT is the first in a family of coils known as the ORBIT GALAXY™ Detachable Coil System, Codman’s next generation, stretch resistant coil platform. The announcement was made here at the Society of NeuroInterventional Surgery (SNIS) 7th Annual Meeting.

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TB4 Improves Neurological Function After Stroke Says Report

Jim Marino — Wed, 21 Jul 2010 08:33:43 +0000

RegeneRx Biopharmaceuticals, Inc. has announced that Thymosin beta 4 (TB4), administered to rats after embolic stroke, improved neurological functional outcome compared to control animals. The research was performed under a Material Transfer Agreement between RegeneRx Biopharmaceuticals, Inc. and the Henry Ford Health System. Improvement in neurological function was measured at various time intervals over a seven week period and was statistically significant.

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FDA Approves Daytrana for ADHD

Jim Marino — Fri, 09 Jul 2010 19:19:32 +0000

The FDA has approved an expanded age range for a methylphenidate transdermal system (Daytrana; Shire, under license from Noven Pharmaceuticals, Inc) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adolescents aged 13 to 17 years. Previously approved for use in children aged 6 to 12 years, the methylphenidate patch is indicated as an integral part of a total treatment program that may include psychological, educational, and social measures.

FDA Advisory Committee Unanimously Votes For the Approval of FTY720

Jim Marino — Fri, 11 Jun 2010 18:36:23 +0000

FDA Advisory Committee affirmed the drugs positive benefit/risk profile and unanimously voted in favor of the approval of FTY720 (fingolimod) as the treatment in relapsing remitting multiple sclerosis. FTY720, potentially first in a new class of MS therapy, represents a significant advance as an efficacious oral treatment for people with relapsing remitting MS.

Successful Phase III Clinical Trial Results Out For NovoCure Novel Medical Device to Treat Recurrent Glioblastoma

Jim Marino — Fri, 11 Jun 2010 07:21:26 +0000

Data from the first phase III clinical trial of NovoCure’s NovoTTF device for treatment of patients with recurrent glioblastoma (GBM) were presented as a late breaking abstract during the Neuro-Oncology session at the American Society of Clinical Oncology (ASCO) Annual Meeting. Study results show that NovoTTF, a portable medical device, may be as or more effective than the best available chemotherapies for GBM, but without the toxicity usually associated with cytotoxic or targeted treatments.

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Synergetics USA to Market Disposable Bipolar Forceps Partner Agreement with Codman & Shurtleff.

Jim Marino — Mon, 14 Dec 2009 12:32:30 +0000

Synergetics USA, Inc. has announced the signing of an addendum to its three year agreement with Codman & Shurtleff, Inc. Under the terms of the revised agreement, Codman will have the exclusive right to market and distribute a Spetzler-Malis branded disposable bipolar forceps produced by Synergetics. This arrangement supports their ongoing efforts to reduce commercial expenses associated with our neurosurgery product lines.

FDA approves INTUNIV

admin — Mon, 07 Sep 2009 07:50:23 +0000

Shire has received approval from the FDA for INTUNIV (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years. The once-daily INTUNIV drug is expected to be available in the US pharmacies by November and will come in four dosage strengths (1 mg, 2 mg, 3 mg, and 4 mg).

Lundbeck epilepsy drug receives FDA approval

admin — Mon, 24 Aug 2009 06:31:41 +0000

Lundbeck Inc has received approval from the FDA for its two New Drug Applications (NDA), Sabril (vigabatrin) Tablets and Oral Solution. Lundbeck will be launching Sabril in the US during the third quarter. Sabril is indicated as a monotherapy for pediatric patients, aged between one month and two years, with infantile spasms for whom the potential benefits outweigh the potential risk of vision loss. The drug is also indicated as an add-on therapy for adult patients with refractory complex partial seizures who have failed other available treatments and for whom the potential benefits outweigh the risk of vision loss.

Neuronetics' Neurostar receives FDA approval

Jim Marino — Mon, 27 Oct 2008 05:00:13 +0000

The Food and Drug Administration (FDA) has given the approval to Neuronetics Inc.’s Neurostar [a transcranial magnetic stimulation (TMS) device] for use in the treatment of depression. The non-invasive tool stimulates the brain by transmitting magnetic pulses to the skull. The device will help the adult patients who have not benefited from anti-depressants. Also, this therapy has no risks as associated with electric shock therapy and surgically implanted electrodes.

Neuronetics’ Neurostar receives FDA approval

Jim Marino — Mon, 27 Oct 2008 05:00:13 +0000