REDUCING THE IMPACT OF SURGERY AND FACILITATING FASTER RECOVERY

Transcription

1 REDUCING THE IMPACT OF SURGERY AND FACILITATING FASTER RECOVERY AORTIC SOLUTIONS

2 PERCEVAL VALVE PERCEVAL THE BIOLOGICAL VALVE OF CHOICE IN AVR 0914 RE /A AORTIC SOLUTIONS

3 PERCEVAL THE BIOLOGICAL VALVE OF CHOICE IN AVR A truly sutureless solution in AVR Perceval helps reducing complexity even in challenging and time consuming procedures With reproducible surgical technique Perceval allows precise positioning both in MICS and traditional surgery At your side in every day practice Perceval is a valuable option to reduce post-operative complications Find out more: 1. Santarpino et al., Ann Thorac Surg 2013;96(1) Santarpino et al., Ann Thorac Surg 2012;94: Gilmanov et al., Ann Thorac Surg 2013;96:2101-8

4 REDUCED TRAUMA OF OPERATION Increased visualization The reduced collapsed profile avoids any trauma to the aortic wall enabling a full and direct view Precise positioning The temporary guiding sutures allow to parachute the valve by guiding it along the annulus axis even in narrow spaces Ease of implant Traditional valves require from 15 to 18 permanent sutures. Perceval is a truly sutureless valve Atraumatic insertion of the device with self-anchoring of the prosthetic valve into its final position, minimizing the risk for iatrogenic aortic dissection or thromboembolic stroke 1 Time saving 78 (2) Isolated AVR X-Clamp time in minutes (means) 55 (3) 61% Cross clamp reduction vs traditional valves 41 (4) 30 (5) Traditional sutured 3f Enable, Medtronic Intuity, Edwards Lifesciences Perceval Find out more: 1. Santarpino et al., Ann Thorac Surg 2013 Jul; 96(1): Phan et al., Ann Cardiothorac Surg X Martens et al., Ann Thorac Surgery 2009;87: Kocher et al., JCTS 2013;145(1): Folliguet et al., Ann Thorac Surg 2012;93:1483-8

5 BETTER PATIENT OUTCOME ICU stay reduction 1 Days (means) 2.8 Traditional sutured 1.9 Perceval Ventilation time reduction Hours (means) Traditional sutured Perceval Less blood transfusion 1 Blood units (means) 2.3 Traditional sutured 1.1 Perceval Find out more: 1. Santarpino et al., Ann Thorac Surg 2013 Jul; 96(1):77-81

6 PERCEVAL INNOVATION STARTS AT ITS CORE A distinctive design built around a SUPER ELASTIC STENT with unique features and mechanical behavior. Following heart movement The Perceval stent is able to adapt to the movements of the aorta during the cardiac cycle. Optimized blood flow The geometric orifice area is maximized, thanks to the absence of a suturing ring 1 providing excellent hemodynamic with stable results over time Mean gradients in mmhg Discarge 3-6 Months 1-4 Years Find out more: 1. Shrestha et al., Interactive CardioVascular and Thoracic Surgery (2013) Folliguet et al., Ann Thorac Surg 2012;93:1483-8

7 A design conceived to enhance durability

8 STENT ELASTICITY Elastic Chain Model Pericardium Stent Stress Optimal stress absorption The elastic structure aims at reproducing the stress absorption properties of the native tissue at the valve commissures level Did you know that The Perceval valve passed a test 3 times harder than what is required by the I.S.O. and F.D.A. guidance (no failure after 600 million cycles). This Perceval valve showed no failure after 2 Billion cycles, equivalent to 50-year heart cycles in-vivo.

9 INNOVATION AND HERITAGE The Perceval tissue component is based on a double sheet design introduced by Sorin in 1985 which has shown excellent results in terms of durability 1,2 NO COLLAPSE 15 min COLLAPSE 60 min COLLAPSE 180 min COLLAPSE Pericardical Cusps: scanning electron microscopy. Elastic Van Gieson and Sirius Red stain at polarized light: collagen waviness in control and at different times of collapse Collapsing, not crimping Examination of the results after collapsing and deployment revealed optimal cusp coaptation and absence of tears, perforation or folding 3 Source: M. Della Barbera SHVD 2011 poster presentation Collapsing: Increases the visibility Allows easier procedure Preserves the integrity of the leaflets Find out more: 1. Folliguet et al., Ann Thorac Surg 2001;71:S D Onofrio et al., J Thorac Cardiovasc Surg 2007;134: Della Barbera et al., abstracts/ Cardiovascular pathology 22 (2013)

10 PRODUCT SPECIFICATIONS code description picture use 1208 Perceval size S 1209 Perceval size M 1210 Perceval size L 1211 Perceval size XL 1235 Dual Collapser S/M 1236 Dual Collapser L/XL 1242 Dual Holder S/M 1243 Dual Holder L/XL 1148 Post-dilatation Catheter - S 1149 Post-dilatation Catheter - M 1170 Post-dilatation Catheter - L 1234 Post-dilatation Catheter - XL 1244 Dual MICS Holder S/M 1245 Dual MICS Holder L/XL 1216 MICS Post-dilatation Catheter - S 1217 MICS Post-dilatation Catheter - M 1218 MICS Post-dilatation Catheter - L 1241 MICS Post-dilatation Catheter - XL 0218TS Inflation Device 1219 Sizers kit Re-usable 1232 Dual Collapser Base Re-usable 1268 Smart Clip 0914 RE (*) Indicated for sternal approach (#) Specifically indicated for Minimally Invasive Cardiac Surgery (including minithoracotomy)

11 0914 RE /A SORIN GROUP ITALIA Srl Via Crescentino Saluggia (VC) Italy Tel Fax