Isolator Synergy Bipolar Radiofrequency Clamps Oct 2018 Content
Isolator® Synergy™ Bipolar Radiofrequency Clamps Oct 2018
Content • Isolator® Synergy™ family • Synergy™ dual electrode technology • Benefits of parallel clamp closure • Dynamic impedance-controlled algorithm • Proven efficacy [ 2 ] Confidential – For Internal Education Use Only – Not for Distribution
Atri. Cure Isolator® Synergy™ Bipolar Radiofrequency Clamps OLL 2 OSL 2 EMR 2 EML 2 EMT 1 Disclaimer: The Atri. Cure Bipolar (Transpolar) System is indicated for ablation and coagulation of soft tissue in general, ENT, thoracic, urological, gynecological surgical procedures and ablation of cardiac tissue during surgery including pulmonary vein isolation and atrial connecting lesions for the Maze procedure for the treatment of cardiac arrhythmias, including atrial fibrillation [ 3 ] Confidential – For Internal Education Use Only – Not for Distribution
OSL 2 & OLL 2: Designed For Open Chest Approaches • 2 electrodes per jaw, gold plated • Parallel jaw closure • OLL 2 jaws (65 mm) are 12 mm longer than OSL 2 (53 mm) jaws • Designed for open chest procedures • Left sided curve to help positioning on the antrum of left atrium Isolator® Synergy™ Standard Jaw (OSL 2) Isolator® Synergy™ Long Jaw (OLL 2) [ 4 ] Confidential – For Internal Education Use Only – Not for Distribution
EML 2 & ORL 2: Designed For Closed Chest Approaches • 2 electrodes per jaw, gold plated • Parallel jaw closure • Designed for closed chest procedures • Left sided curve for the left side Isolator® Synergy™ Clamp Left Curve (EML 2) Isolator® Synergy™ Clamp Right Curve (ORL 2) [ 5 ] Confidential – For Internal Education Use Only – Not for Distribution • Right sided curve for the right side • Glidepath guides
Isolator® Synergy™ Access® Clamp (EMT 1) Removable Glidepath guide Locking Knob Pivot • Parallel jaw closure • Right sided curve • Allows for superior or inferior approach • Designed for open or closed chest procedures Jaw Articulation ± 30° • ± 30∘ articulated end helps with positioning • Locking knob keeps the articulated jaw in the selected position [ 6 ] Confidential – For Internal Education Use Only – Not for Distribution
Unique Synergy™ Dual Electrode Technology Designed For Robust Lesion Formation Conventional Bipolar Conventional mono-electrode technology leaves the possibility to electrical signals to escape through the weakness of the lesion [ 7 ] Confidential – For Internal Education Use Only – Not for Distribution Isolator® Synergy™ Clamp The Isolator® Synergy™ Clamp 2 pairs of alternating bipolar electrodes generate alternating and overlapping fields to form a lesion from where the RF energy fields overlap to the surface, resulting in a wider column-shaped transmural lesion
Isolator® Synergy™ Technology Performance Atri. Cure Synergy™ Bipolar Clamp Parallel closure Conventional Bipolar Clamp Hinged closure 2 Pairs of Alternating Electrodes 1 Pair of Electrodes Robust column-shaped Lesion [ 8 ] Confidential – For Internal Education Use Only – Not for Distribution
Consistent Tissue Compression And Precise Electrode Alignment Across Entire Jaws’ Length • Isolator® Synergy™ stainless steel shaft and jaws maintain complete and consistent tissue pressure leading to even and consistent energy delivery • Consistent tissue pressure and precise alignment ensure robust column-shaped lesions regardless of where the tissue is positioned within the jaws [ 9 ] Confidential – For Internal Education Use Only – Not for Distribution
Isolator® Synergy™ Energy Delivery Performance Atri. Cure Synergy Bipolar Clamp Parallel closure • Isolator® Synergy™ Clamps’ consistent tissue compression performs better across varying tissue thicknesses Parallel Jaw Pressure at Increasing Tissue Thickness Conventional Bipolar Clamp Hinged closure Hinged Jaw Pressure at Increasing Tissue Thickness [ 10 ] Confidential – For Internal Education Use Only – Not for Distribution ü Isolator® Synergy™ Parallel closure clamps are 3. 7 -10. 3 x more likely to create a transmural lesion Varzaly JA et al, Interact Cardio. Vasc Thorac Surg (2018) 1 -9
Isolator® Synergy™ Dynamic RF Energy Delivery • The Isolator® Synergy™ devices’ dynamic monitoring algorithm measures the tissue’s response to the RF delivery 50 times per second adjusts energy output and time accordingly • The result is a custom-made column-shaped lesion specific to a tissue’s length, width and composition • Ensuring transmural lesions without delivering excess energy TISSUE 1 TISSUE 2 TISSUE 3 Display of different ablation graphs of power and time based on the specific requirements of individual tissue composition and thickness Voeller, R. K. , Zierer, A. , Schuessler, R. B. , & Damiano Jr, R. J. (2011). Performance of a novel dual-electrode bipolar radiofrequency ablation device: a chronic porcine study. Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery, 6(1), 17 -22 [ 11 ] Confidential – For Internal Education Use Only – Not for Distribution
Isolator® Synergy™ Proven Efficacy • Atri. Cure ABLATE trial led to FDA approval for Isolator® Synergy™ OSL 2/OLL 2 clamp claim to treat AF ABLATE: The Annals of Thoracic Surgery. Volume 100, Issue 5, November 2015, Pages 1541 -1548 Presented at the Late Breaking Session of the Fifty-first Annual Meeting of The Society of Thoracic Surgeons, San Diego, CA, Jan 24– 28, 2015. [ 12 ] Confidential – For Internal Education Use Only – Not for Distribution
Maze IV Lesion Set [ 13 ] Confidential – For Internal Education Use Only – Not for Distribution
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