Contour Neurovascular System™
Targets the neck of the aneurysm
Designed to treat a range of aneurysm morphologies including unruptured wide-necked bifurcation and bifurcation aneurysms:
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Provides a combination of flow diversion at the neck of the aneurysm and flow disruption within the aneurysm sac;
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Supports neo-intimal growth across mesh at neck and subsequent thrombosis of aneurysm;
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Deployed with proven existing clinical techniques;
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A single device occlusion that is re-sheathable & re-deployable;
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Electrolytic method of detachment;
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Strong IP portfolio - 3 patents issued and 3 patents pending;
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No intra-arterial stabilizing component;
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Reduces/eliminates need for dual anti-platelet therapy;
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Simplified sizing approach compared to other intra-saccular devices (i.e. neck and widest diameter only).
How safe and effective are existing treatments for wide-necked bifurcation aneurysms?
Literature based objective performance criteria for safety and effectiveness
Journal of Neurointerventional Surgery, October 11, 2017
Meta-Analysis, Fiorella et al.
Description Outcome (1yr)
Wide Neck Bifurcation Aneurysm 2,795
Complete Occlusion 40%
Adequate Occlusion 70%
Conclusion: Conventional therapies for WNBAs are associated with relatively low rates of complete occlusion and peri-procedural complications are not uncommon. Newer therapies are needed for the treatment of these aneurysms. Until a ‘gold standard’ treatment strategy is established, these emerging technologies can be evaluated in comparison to the benchmark literature-derived OPC presented*.
What does it take to be a “big believer” in intrasaccular devices?
Tufail Patankar (UK) speaks about his personal experience with these effective tools, during the LINNC, Paris 2019 Congress.
Indications for Use
Prior to use, refer to the Instructions for Use supplied with products for indications, contraindications, warnings, precautions, and suggested procedure. The Contour 021 & Contour Neurovascular System™ Models CNS21005, CNS21007-15, CNS21009-15, CNS011-15 and CNS014-15 meet the essential requirements referred to in Article 3 of the MDD 93/42/EEC and are labelled with the CE Marking of conformity.
Magnetic Resonance Imaging (MRI) Safety Information
Non-clinical testing demonstrated that the Contour implant is MR Conditional. A patient with this device can be scanned safely in an MR system immediately after placement under the following conditions:
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Static magnetic field of 1.5 Tesla and 3 Tesla, only
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Maximum spatial gradient magnetic field of 2,000-gauss/cm (20 Tesla/m) (extrapolated) or less
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Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4 W/kg for 15 minutes of scanning (i.e., per pulse sequence) in the First Level Controlled Operating Mode of operation for the MR system.
Under the scan conditions defined above, the implant is expected to produce a maximum temperature rise of 2.3°C after 15 minutes of continuous scanning (i.e., per pulse sequence).
In non-clinical testing, the image artifact caused by the implant extends approximately 10 mm from the implant when imaged using a gradient echo pulse sequence and a 3 Tesla MR system.
Contour Neurovascular System™: CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use.
Indications for Use
The Contour Neurovascular System™ is indicated for the endovascular embolization of intracranial aneurysms.
Contraindications
• Patient anatomy or physiology considered unsuitable for endovascular treatment
• Allergy to platinum, nickel or titanium