Sequent Medical Announces Presentation of Compelling Long-Term Clinical Data and Commercial Release of its Next Generation WEB Product

Sequent Medical, Inc. announced today the presentation of prospective long-term clinical data for the WEB™ Aneurysm Embolization System at the recent Société Française de Neuroradiologie (“SFNR”) meeting in Paris, France. Twelve-month data were reported from two separate prospective, multi-center, core lab reviewed studies called WEBCAST and the French Observatory. Results are preliminary, with full data analysis to be made available later this summer.
Safety and aneurysm occlusion rates were examined in patients with complex wide neck bifurcation aneurysms (mean neck size: 5.5 mm) treated with the WEB in 15 European centers. The studies demonstrated 53% complete and 81% adequate occlusion in 96 patients with one-year imaging. As previously reported, safety results were excellent, with 2.7% procedure-related morbidity and 0% mortality at 30 days.
“We are pleased to find significant and stable aneurysm occlusion rates out to one year even in these difficult to treat aneurysms. When coupled with an impressive safety profile, these results are simply outstanding,” said Prof Laurent Pierot MD PhD, Head of the Department of Radiology, Maison Blanche Hospital, Reims, France, who presented the data at the SFNR meeting.
These results add to a steadily increasing body of clinical evidence for the WEB which now includes over 200 patients enrolled across four separate prospective, multi-center clinical studies. These studies are the WEB-IT Investigational Device Exemption study in the United States and three ongoing European studies (WEBCAST, French Observatory, and WEBCAST 2). In addition to the prospective studies, there are now over 15 peer-reviewed clinical publications on the WEB and over 1,600 patients treated. “Given this level of evidence, the WEB is an increasingly well established therapy with an important and growing role in the management of intracranial aneurysms,” said Prof. Pierot.
In other news, Sequent announced the commercial launch of its latest generation WEB product, which features a further reduction in delivery profile of the WEB down to .021 inches. The .021” system also includes a downsized version of the company’s existing VIA® microcatheter. The lower profile of the new system will improve the deliverability of the WEB, and is designed to enable physicians to treat an even broader range of aneurysms with the WEB.
The company recently completed a controlled release of the new system in select neurovascular centers that gathered initial physician feedback prior to full market release. The feedback from over 40 cases across 10 centers was outstanding. “I used the .021” system in a series of recent cases and I have been extremely impressed,” said Prof Istvan Szikora MD, Head of the Department of Neurointerventions, National Institute of Clinical Neurosciences, Budapest, Hungary. “The .021” system represents a major advance for the WEB platform with the potential to significantly increase the number of aneurysms that I can treat with this technology.”
Initially, the .021” system will be available for all WEB implants up to 7 mm in diameter, which represents a majority of WEB cases. “The .021” system is a breakthrough that positions us well for further adoption and growth, particularly in the ruptured segment of the aneurysm market, and we are very optimistic about the significant role the WEB can play in the treatment of intracranial aneurysms,” said Sequent President and CEO Tom Wilder. “Building on our demonstrated expertise with innovative braided devices, we also have several active development projects underway focused on offering an expanded portfolio of products to neurovascular specialists and their patients.”

Intracranial hypotension: clinical presentation, imaging findings, and imaging-guided therapy

Intracranial hypotension is a condition in which there is negative pressure within the brain cavity.

Etiology

see Spontaneous intracranial hypotension
Cerebrospinal fluid leak from the spinal canal:
A leak following a lumbar puncture (spinal tap).
A defect in the dura
Sometimes following exertion such as swinging a golf club.
A congenital weakness.
Following spinal surgery.
Following spinal trauma.
Following a shunt procedure for hydrocephalus.
Lumboperitoneal shunt.
Ventriculoperitoneal shunt with a low pressure valve.
In some cases, spinal CSF leaks can lead to a descent of the cerebellar tonsils into the spinal canal, similar to a Chiari malformation.
Large spinal dural defects can lead to herniation of the spinal cord into the defect.

Symptoms

The classic symptom is severe headache when upright, which is relieved when lying flat.
Other symptoms can include nausea, vomiting, double vision and difficulty with concentration.
The typical clinical manifestation – orthostatic headache – may be masqueraded by atypical clinical findings, including coma, frontotemporal dementia, leptomeningeal hemosiderosis-associated symptoms, and others.

Diagnosis

Diagnosis is usually suspected based on the postural dependency of the headache, although in many cases the diagnosis of intracranial hypotension is not considered for some time.
A contrast-enhanced brain magnetic response imaging (MRI) scan typically shows thickened and brightly enhancing meninges (pachymeningeal enhancement). Other findings include descent of the thalamus and cerebellar tonsils.
MRI signs are highly specific, but the imaging strategy to search for spinal cerebrospinal fluid leaks (none, computed tomography myelography, magnetic resonance myelography with gadolinium, digital subtraction myelography) is a matter of debate 1).
Continuous intracranial pressure monitoring is definitive for documenting abnormally negative intracranial pressures.
The identification of the site of CSF leak in the spinal canal can be very challenging. In some cases, the site cannot be identified. Methods include:
Dynamic myelography with fluoroscopy and computed tomography (CT).
Radioisotope cisternography.
Spinal MRI.

Treatment

If the site of the spinal CSF leak can be identified, then options include:
Epidural blood patch, performed by an anesthesiologist pain management specialist.
Surgical repair of the defect.
Over-draining CSF shunts are managed by replacing the valve with one that drains less.
Lumboperitoneal shunts may have to be removed or ligated.

Outcome

If the cause of the intracranial hypotension can be identified, the outcome following treatment is typically excellent.
1) Urbach H. Intracranial hypotension: clinical presentation, imaging findings, and imaging-guided therapy. Curr Opin Neurol. 2014 Aug;27(4):414-24. doi: 10.1097/WCO.0000000000000105. PubMed PMID: 24978633.
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