Solitaire FR Revascularization Device

Transcription

1 Solitaire FR Revascularization Device FEATURING PARAMETRIC DESIGN Restore. Retrieve. Revive. 5

2 Revolutionizing Mechanical Thrombectomy with Parametric Design Solitaire FR Device The Solitaire FR revascularization device featuring PARAMETRIC Design, an overlapping stent-based technology, provides revolutionary technology to restore flow, retrieve clot, and revive neurological tissue. 5 FASTER 5 Flow Restoration IMPROVED 5 Clot Retention PARAMETRIC DESIGN BALANCED 4 Delivery Performance MAINTAIN 3 Intimal Integrity

3 Solitaire FR Revascularization Device Restore Flow Unique stent-based design. Fast flow restoration. The Solitaire FR device s self-expanding stent-based design creates a simple, single-operator procedure. 1 RADIAL FORCE 4 FAST FLOW RESTORATION 0.08 Deployment Retrieval INITIAL ANGIOGRAM AFTER INITIAL DEPLOYMENT 0.06 Radial Force (N/mm) Constrained Diameter (mm) Based on an average of N=3 4x20 Solitaire FR Revascularization Devices Maximized radial force when deployed within occlusion to facilitate fast flow restoration. Case study images provided with permission by Prof. Andersson, Karolinska Hospital, Helsinki, Sweden. Flow restoration to the MCA upon deployment of the Solitaire FR device. REFERENCES 1. Design Specification: PS08-001F. 2. Covidien Testing Data: FD2601A. 3. TR08-136: In Vivo Evaluations of Solitaire FR Devices for Flow Restoration in a Chronic Swine Model 4. FD2815: Competitive Device Test Plan---Flow Restoration Device. 5. Solitaire FR with the Intention for Thrombectomy (SWIFT) Study SWIFT IDE # G FD2923. Please see page 5 of this brochure for supporting study data.

4 Retrieve Clot Maximize clot retrieval. An average of 1.7 passes per procedure. 5 VESSEL WALL Clot Solitaire FR Device deployed VESSEL WALL Depiction of a 4x20 Solitaire FR Device in a vessel. Solitaire FR device with Parametric Design provides multiple planes of clot contact to enhance capture. 2 CELL AREA 4 WALL APPOSITION % of area maintained mm mm 2 mm mm 2 3.0mm 2 Cell Area in constrained tube. Based on an average of N=2 4x20 Solitaire FR Revascularization Devices. Parametric Design preserves cell-size over varying vessel diameters. Solitaire FR Revascularization Device in a 3mm vessel. An optimal balance of navigability, wall-apposition, and clot retention.

5 Revive Neurological Tissue 5 SWIFT Study: Recanalization Rates % 83.3% 48.1% Next generation technology. Revolutionary clinical results. 24.1% Solitaire FR Device 37/54 16/53 CORE LAB REVIEWED Superiority p-value Solitaire FR Device 45/54 26/54 SITE REPORTED Superiority p-value Compared to the Merci Retriever the Solitaire FR device provides a 2.5x improvement in successful recanalization. SWIFT STUDY: Neurological Outcomes 5 SWIFT STUDY: Mortality Rates % 33.3% 38.2% 17.2% Solitaire FR Device 32/55 16/48 Solitaire FR Device 10/58 21/55 Good neurological outcome defined as mrs 2, or equal to the prestrike mrs if the prestroke mrs was higher than 2, or NIHSS score improvement of 10 points or more. Solitaire FR device demonstrates a 1.7x improvement in good neurological outcomes at 90 days vs. the Merci Retriever. Solitaire FR device reduces Mortality by 55% compared to the Merci Retriever.

6 A size matrix of 4 mm and 6 mm diameters optimizes performance in the MCA, Carotid, and Basilar arteries. Solitaire FR Revascularization Device Ordering Information Reference Number Recommended Vessel Diameter (mm) (A) Total Length (mm) (B) Retrieval Zone (mm) (C) Device Diameter (mm) (D) Push Wire Length (cm) (E) Distal Markers (F) Proximal Markers Minimum Micro Catheter ID (in) SFR SFR SFR SFR Rebar Micro Catheter Ordering Information Reference Number Catheter Class Usable Length (mm) Maximum Guidewire ID (in) Minimum Guidewire ID (in) Proximal OD a F 2.4 F F 2.4 F F 2.8 F F 2.8 F Distal OD DEVICE DETAILS (A) Total Length a Dual Marker Band. (B) Retrieval Zone (C) Diameter (D) Push Wire Introducer Sheath (E) Distal Markers (F) Proximal Marker For general inquiries or to learn more about our Physician Workshop and Center of Excellence, please stroke@covidien.com The Solitaire FR revascularization device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-pa) or who fail IV t-pa therapy are candidates for treatment (A) JAN/12 Indications, contraindications, warnings and instructions for use can be found on the product labeling supplied with each device. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. COVIDIEN, COVIDIEN with logo, and Covidien logo are US and internationally registered trademarks of Covidien AG. TM* Trademark of its respective owner. Other brands are trademarks of a Covidien company. Covidien 9775 Toledo Way Irvine, CA USA PH FX