At the heart of life. At the heart of precision
29Pages

At the heart of life. At the heart of precision.

MyVal-1 Study Favourable * Outcomes at 1-year MyVal-1 study, one year results presented by Dr. Ravinder Singh Rao at PCR Valves e-Course 2020 Device-related Mortality Incidence of Stroke New Permanent Pacemaker

Open cells on upper half to ensure un-jailing of coronary ostia Closed cells on lower half for high radial strength Hybrid Honeycomb Cell Design Concept Myval THV: Designed for Precision in Outcomes Internal PET sealing cuff for minimizing PVL & puncture resistance Cobalt alloy frame for high radial strength & radiopacity AntiCa$ treated bovine pericardium tri-leaflet valve External PET skirting to plug microchannels & further reduce PVL Myval THV has been indigenously developed by Meril Life Sciences Pvt. Ltd. AntiCa$ - Meril's proprietary anti-calcification treatment technology All Myval...

Myval THV: Unique Crimping Outcome Upon Crimping: V-shaped hinges on hexagonal frame fold, generating the dense bands on fluoroscopy Vertical connectors ‘|’ give rise to light bands Alternating V-folds & vertical connectors give Myval THV a unique ‘Zebra Crossing’ appearance on fluoroscopy for ease of positioning 4th Dense Band 3rd Light Band 2nd Light Band 2nd Dense Band 1st Light Band Ventricular End Myval THV is recommended to be crimped over Navigator THV Balloon Delivery System prior to insertion within introducer sheath Illustrations are artist's representation and should not be...

Myval THV: Precise Placement Technique Schematic of Myval THV - Ideal Landing Zone Minimum foot-print in LV (70% Aortic : 30% Ventricular) Minimal movement across the annulus to locate the THV landing zone Proximal Balloon Marker Landing Zone 2nd Dense band Annular Plane 1 Light Band 1st Dense Band Upon Crimping Alternating V-folds & vertical connectors give Myval THV a unique appearance on fluoroscopy for ease of positioning Distal End Towards Ventricle Elimination of THV frame parallax promptly ensures visualisation of characteristic dark-light bands Fluoroscopic images have been...

Myval THV: Ground Zero Deployment Ÿ Ÿ Ÿ Shallow deployment of Myval THV with least engagement within LVOT is possible Optimal orthotopic anchorage of Myval THV with marginal LVOT foot-print without risk of THV migration Minimal infra-annular depth ≤3.50mm avoids conduction system interference (thus minimizing the need of new permanent pacemaker dependency) Largest circumscribable diameter in Open Cell (for all Myval THV Diameters 20mm to 32mm) Myval THV infra-annular depth ≤3.50mm based on THV Ø Image ref : Tawara et al. JACC CardioVascular Interventions 2008; 1:310-316. Angio image...

Myval THV: Detailed Sizing Guide 3D Annular area mm2 % Annular area over/under % Annular area over/under % Annular area over/under % Annular area over/under % Annular area over/under Area-derived diameter based on MSCT cross-sectional measurements

Myval THV: Size Matrix Myval THV Size Matrix & Technical Specifications Native annulus area Area-derived diameter Native annulus size by TEE

All Myval THV Diameters (20 mm to 32 mm) are Compatible with 14Fr Python - Introducer Sheath Myval THV XL Sizes

Myval THV: Post Deployment Dimensions Chart 21.5 mm Open cell height (53%) Closed cell height (47%) Infra-annular depth Supra-annular height of closed cells Recommendation for coronary protection Total frame height Largest circumscribable A balloon occlusion test may be considered to assess the propensity for coronary occlusion Balloon diameter approximated to shortest axis of CT-derived annular diameter to be considered diameter in Open Cell (for all Myval THV Diameters 20mm to 32mm) * Infra-annular depth may depend on final landing zone position prior to valve deployment. The values...

• Consider protection of coronary arteries with a DES especially if height of coronary ostium is <10 mm from the annular plane and in conjunction with sinus of valsalva dimensions i.e. height & diameters

Navigator THV Delivery System Delivering TAVI Made Easy Myval THV is recommended to be crimped over Navigator THV Delivery System prior to insertion within introducer sheath The crimped valve with delivery system is then loaded through 14Fr Python – Introducer Sheath Proximal Stopper Crimped Valve Distal Stopper Navigator with Myval THV Navigator delivery system has a set of proximal and distal stoppers which ensure that valve crimping is precise and snug Visual confirmation of crimped valve can be ensured before entering the sheath to avoid any crimping errors/defects The stoppers prevent...

Navigator THV Delivery System Characteristic Balloon Expansion Navigator balloon with dual expansion ports at each end ensures rapid, simultaneous, controlled expansion (dog-boning) of distal and proximal ends This typical dog bone pattern of inflation steadies the valve during expansion phase, ensuring its precise annular position and deployment without any risk of valve migration Rapid balloon inflation, using an inflation device is possible with controlled palm thrust Rapid balloon deflation within 3-5 sec ensures procedural safety and compl

Navigator THV Delivery System 0.035” guide wire Usable catheter length 120 cm Proximal Shaft with Rotatory Handle for Hi-Flexion Balloon Length Volume of 75:25 Saline: Contrast to achieve stated balloon diameter Navigator – THV Delivery System has been indigenously developed by Meril Life Sciences Pvt. Lt

Navigator THV Delivery System: Proximal Assembly Clock-wise rotation to achieve distal end flexion 0.035” guide wire exit port Proximal shaft with rotatory handle for Hi-Flexion Un-deflected catheter position (straight) Maximum deflection catheter position Balloon inflation port Hi-flexion feature ensures tracking the THV delivery system via inner aortic arch curve thereby minimizing the risk of contralateral wall scraping Caution: Always remember to fully un-flex the Navigator system while

14Fr Python – Introducer Sheath Compatible with all Myval THV Diameters (20 mm to 32 mm) Sheath expands momentarily like a python swallowing its prey Conveniently allows passage of crimped Myval THV System 14Fr Entry Profile, Allows Atraumatic Percutaneous Access High convenience for full retrievability of an un-deployed Myval THV System Proximal Port with Hemostatic valves Counter opposing suturing eyelets Lubricious, hydrophilic shaft coating Dilator with locking threads Seamless transition from dilator to distal tip Convenient side port with 3-way Two separate, calibrated loading tubes...