Jena Valves Aortic Clip Concept for Aortic Valve

  • Slides: 25
Download presentation
Jena. Valve`s Aortic Clip Concept for Aortic Valve Replacement Hans R. Figulla MD, Ph.

Jena. Valve`s Aortic Clip Concept for Aortic Valve Replacement Hans R. Figulla MD, Ph. D University Heart Center, Jena, Germany

Disclosures

Disclosures

Agenda 1. 2. 3. 4. 5. 6. Introduction/Vision/Mission Technology and Device Implantation Technique Clinical

Agenda 1. 2. 3. 4. 5. 6. Introduction/Vision/Mission Technology and Device Implantation Technique Clinical Studies Animal Trial Transfemoral Competition Overview © Jena. Valve™ Technology Gmb. H 2011 | confidential 7. Market Overview 8. Strategy and Timing 9. Jena. Valve Organization 10. Patent and IP Status 11. Financials 12. Summary

The Past of the Future 1995 Past Future Percutaneous aortic valve Valvuloplasty

The Past of the Future 1995 Past Future Percutaneous aortic valve Valvuloplasty

Technology The Jena. Valve technology in 2003/2004 } Self-expanding Nitinol } Second ring with

Technology The Jena. Valve technology in 2003/2004 } Self-expanding Nitinol } Second ring with hooks } Pulmonary/pericardial valve © Jena. Valve™ Technology Gmb. H 2007 page 4

Technology The Jena. Valve technology in 2003/2004 } Bioprosthesis for valve replacement with a

Technology The Jena. Valve technology in 2003/2004 } Bioprosthesis for valve replacement with a self-expanding stent © Jena. Valve™ Technology Gmb. H 2007 page 5

Technology The Jena. Clip and its unique fixation elements TM Positioning feeler Clipping area

Technology The Jena. Clip and its unique fixation elements TM Positioning feeler Clipping area Anchoring hoop: Valve fixation bar Pocket bar © Jena. Valve™ Technology Gmb. H 2007 page 6

Jena. Valve. TM TAVI System Transapical The Jena. Valve Stent © Jena. Valve™ Technology

Jena. Valve. TM TAVI System Transapical The Jena. Valve Stent © Jena. Valve™ Technology Gmb. H 2011 | confidential The Jena. Valve Prosthesis The Jena. Valve Delivery System page 7

Agenda 1. 2. 3. 4. 5. 6. Introduction/Vision/Mission Technology and Device Implantation Technique Clinical

Agenda 1. 2. 3. 4. 5. 6. Introduction/Vision/Mission Technology and Device Implantation Technique Clinical Studies Animal Trials Transfemoral Competition Overview © Jena. Valve™ Technology Gmb. H 2011 | confidential 7. Market Overview 8. Strategy and Timing 9. Jena. Valve Organization 10. Patent and IP Status 11. Financials 12. Summary

Transcatheter Aortic Valve Implantation (TAVI) Transapical Surgery Transfemoral Cardiology Indicated for high risk or

Transcatheter Aortic Valve Implantation (TAVI) Transapical Surgery Transfemoral Cardiology Indicated for high risk or inoperable patients Small left anterior thoracotomy at the fifth or sixth intercostal space © Jena. Valve™ Technology Gmb. H 2011 | confidential Percutaneous access at the groin into the iliac artery page 9

12345678 Balloon Valvuloplasty } To separate the calcified valve leaflets © Jena. Valve™ Technology

12345678 Balloon Valvuloplasty } To separate the calcified valve leaflets © Jena. Valve™ Technology Gmb. H 2011 | confidential page 10

12345678 Insertion of the Jena. Valve catheter } High visibility } Flexible catheter shaft

12345678 Insertion of the Jena. Valve catheter } High visibility } Flexible catheter shaft © Jena. Valve™ Technology Gmb. H 2011 | confidential page 11

12345678 Release of the positioning feelers } Unsheathe feelers } Orientation with markers }

12345678 Release of the positioning feelers } Unsheathe feelers } Orientation with markers } Possibility of recapturing © Jena. Valve™ Technology Gmb. H 2011 | confidential page 12

12345678 Check by Fluoroscopy } Prosthesis in correct position } Feelers located } Tactile

12345678 Check by Fluoroscopy } Prosthesis in correct position } Feelers located } Tactile feedback © Jena. Valve™ Technology Gmb. H 2011 | confidential page 13

12345678 Release of prosthesis } Clipping on calcified leaflets } Release from catheter ©

12345678 Release of prosthesis } Clipping on calcified leaflets } Release from catheter © Jena. Valve™ Technology Gmb. H 2011 | confidential page 14

12345678 Final result } } Correct position No leakage Free from coronary ostia Ideal

12345678 Final result } } Correct position No leakage Free from coronary ostia Ideal haemodynamics © Jena. Valve™ Technology Gmb. H 2011 | confidential page 15

Agenda 1. 2. 3. 4. 5. 6. Introduction/Vision/Mission Technology and Device Implantation Technique Clinical

Agenda 1. 2. 3. 4. 5. 6. Introduction/Vision/Mission Technology and Device Implantation Technique Clinical Studies Animal Trials Tansfemoral Competition Overview © Jena. Valve™ Technology Gmb. H 2011 | confidential 7. Market Overview 8. Strategy and Timing 9. Jena. Valve Organization 10. Patent and IP Status 11. Financials 12. Summary

First in man trial Patient Demographics* Number of Patients Female Age NYHA class EUROSCORE

First in man trial Patient Demographics* Number of Patients Female Age NYHA class EUROSCORE (points) Log EUROSCORE (%) LVEF (%) Annulus diameter (mm) Procedural Outcome 9 9 87 ± 6 ** III 11 ± 2 ** 22. 4 ± 8. 6 60 ± 6 21. 6 ± 0. 5 Initial procedures Aborted procedures *** Successful implantations Death periprocedural MACCE periprocedural NO onset of AV block 12 3 9 0 1 0 * All completed implantations, included in calculation (n=9); ** Full data range; *** One patient was converted due dissection delivery system modified; Two patients presented unsuitable aortic anatomy procedure aborted © Jena. Valve™ Technology Gmb. H 2011 | confidential page 17

First in man trial Echocardiographic Results* Baseline (Mean ± SD) Discharge (Mean ± SD)

First in man trial Echocardiographic Results* Baseline (Mean ± SD) Discharge (Mean ± SD) 3 Months** (Mean ± SD) 6 Months** (Mean ± SD) AV Vmax (m/s) 3. 70 ± 1. 10 1. 95 ± 0. 24 2. 08 ± 0. 30 1. 97 ± 0. 27 AV max PG (mm. Hg) 62. 9 ± 29. 7 15. 4 ± 3. 4 17. 5 ± 5. 0 15. 9 ± 4. 4 AV mean PG (mm. Hg) 41. 0 ± 20. 4 9. 6 ± 2. 6 9. 3 ± 2. 2 8. 1 ± 1. 6 LV Ejection Fraction (%) 60. 0 ± 6. 0 56. 0 ± 9. 0 54. 7 ± 17. 5 * All completed implantations, included in calculation (n=9); ** All available data until now (n=7) © Jena. Valve™ Technology Gmb. H 2011 | confidential page 18

First in man trial Paravalvular Regurgitation None Post procedure © Jena. Valve™ Technology Gmb.

First in man trial Paravalvular Regurgitation None Post procedure © Jena. Valve™ Technology Gmb. H 2011 | confidential Trace Minimal (Grade 1) 3 months Moderate (Grade 2) 6 months page 19

Echocardiographic Results *n=9; **n=7 © Jena. Valve™ Technology Gmb. H 2011 | confidential page

Echocardiographic Results *n=9; **n=7 © Jena. Valve™ Technology Gmb. H 2011 | confidential page 20

Agenda 1. 2. 3. 4. 5. 6. Introduction/Vision/Mission Technology and Device Implantation Technique Clinical

Agenda 1. 2. 3. 4. 5. 6. Introduction/Vision/Mission Technology and Device Implantation Technique Clinical Studies Animal Trials Transfemoral Timeline © Jena. Valve™ Technology Gmb. H 2011 | confidential 7. Market Overview 8. Strategy and Timing 9. Jena. Valve Organization 10. Patent and IP Status 11. Financials 12. Summary

Transapical and transfemoral study status 2010 Transapical (porcine) 2011 2012 2013 05 FIM trial

Transapical and transfemoral study status 2010 Transapical (porcine) 2011 2012 2013 05 FIM trial 06 CE-Mark trial 07 09 CE-Mark 06 Transfemoral & tansapical (pericard) 01 Pre-clinical 05 FIM trial 02 11 CE-Mark trial 07 02 CE-Mark 12 © Jena. Valve™ Technology Gmb. H 2011 | confidential page 22

Puts the surgeon in control Feeler-guided positioning © Jena. Valve™ Technology Gmb. H 2011

Puts the surgeon in control Feeler-guided positioning © Jena. Valve™ Technology Gmb. H 2011 | confidential Provides active fixation, resistance to migration Unique Jena. Clip™ anchoring mechanism Best anatomical positioning Repositionability and retrievability page 23

Thank you for your attention © Jena. Valve™ Technology Gmb. H 2011 | confidential

Thank you for your attention © Jena. Valve™ Technology Gmb. H 2011 | confidential page 24