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St Jude Medical Competitive Info Pack

St Jude Medical Competitive Info Pack. IMPORTANT How to Use the Competitive Info Pack. This info pack is to be reviewed only by Medtronic personnel . This material is not to be presented or distributed to physicians.

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St Jude Medical Competitive Info Pack

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  1. St Jude Medical Competitive Info Pack

  2. IMPORTANTHow to Use the Competitive Info Pack • This info pack is to be reviewed only by Medtronic personnel. • This material is not to be presented or distributed to physicians. • Confidential. For internal use only by Medtronic personnel. Do not copy or distribute.

  3. Introduction The St Jude Medical Competitive Info Pack module will provide you with the latest info on competitor systems and will help you position the Symplicity™ Renal Denervation System as the best RDN solution for your customers and patients.

  4. Learning Objectives • Describe the EnligHTN™ Multi-Electrode Renal Denervation System • Articulate the key clinical data generated by the EnligHTN™ Multi-Electrode Renal Denervation System • Compare and contrast the EnligHTN™ Multi-Electrode Renal Denervation System with the Symplicity™ Renal Denervation System • Effectively handle sales objections

  5. St Jude Medical Competitive Info Pack Section 1: Company Overview

  6. St Jude Medical Overview St. Jude is a top competitor and will leverage its existing cardiovascular and cardiac rhythm management business to enter the RDN market.

  7. St Jude Medical Launch Timeline and Clinical Trial Status EnligHTNTMMulti-Electrode Renal Denervation System Received CE Mark Approval in May 2012 Geographies with Commercial Activities • CEE • AP • LATAM • WECA • ANZ • MEA TCT2013, clinicaltrials.gov, and press releases

  8. St Jude Medical Competitive Info Pack Section 2: Product Overview

  9. Product Overview RDN Technology Presented at TCT 2012 and from St. Jude EnligHTN brochure

  10. Product Overview EnligHTN™ Renal Artery Ablation Catheter  St. Jude EnligHTN brochure

  11. Product Overview EnligHTN™ RF Ablation Generator – 1st generation Presented at AHA 2012 and TCT 2012

  12. Product Overview 2nd Generation EnligHTN™ System Additional Points • No change to catheter or guide catheter • Ablation time reduced to 4 minutes total Key Takeaways • Still 8F compatible • Bulky and difficult to maneuver in renal artery Presented at EuroPCR 2013

  13. Knowledge CheckMatch the question to the correct response.

  14. Knowledge Check

  15. St Jude Medical Competitive Info Pack Section 3:Clinical Overview

  16. Clinical Overview EnligHTN-1 Overview: First in Man study with 1st Gen EnligHTN™ System Presented at TCT 2013 and EuroPCR2013

  17. Clinical Overview EnligHTN-1 Baseline Data presented at TCT2013

  18. Clinical Overview EnligHTN-1 Clinical Results • Summary of Data from EnligHTN-1 Study • (No major changes from 12 month data) • 77% responders at 18 months (>10 mmHg change in OBP) • No serious peri-procedural events • Serious device/procedure events through 18 months: • Worsening of pre-existing proteinuria (n=1) • Symptomatic hypotension (n=1) • Worsening of pre-existing renal artery stenosis and new stenotic lesion (n=2 events in 1 patient) • There have been other minor procedural related events reported such as hematoma (5), vasovagal episodes (2), hypotensive episodes (2) and bradycardia (2) EnligHTN-1 18 Month Data Data presented at TCT2013

  19. Clinical Overview EnligHTN-3 Overview: First in Man study with 2st Gen EnligHTN™ System Presented at TCT 2013

  20. Clinical Overview EnligHTN-3 Baseline Data presented at TCT2013

  21. Clinical Overview EnligHTN-3 Procedure Data Data presented at TCT2013

  22. Clinical Overview EnligHTN-3 Clinical Results EnligHTN-III 3 Month Data • Summary of Data from EnligHTN-3 • Responder rates (>10 mmHg change in OBP): 67% at 1 month, 85% at 3 months • No serious device/procedure events • Non-serious device/procedure related events: • Vascular access site hematoma, vascular access site bruise, vascular access site drainage, non-flow limiting vasospasm, back pain, pain, vascular access site pain, hypotensive episodes Data presented at TCT2013

  23. Clinical Overview Key Points • This is a First in Man (FIM) study conducted at 4 centers in Greece and Australia • The EnligHTN-1 study was recently published in the Euro Heart Journal (Eur Heart J. 2013 Jul;34(28):2132-40) • This is a small trial studying only 46 patients with a follow-up of 12 months • There are minor safety complications with 11 reports of procedural related events, mainly hematoma • The responder rate (>10 mmHg systolic BP reduction) was 80% at 12 months

  24. St Jude Medical Competitive Info Pack Section 4: Selling Against the EnligHTN™ system

  25. Selling Against the EnligHTN™ system Strengths Weaknesses Opportunities Threats

  26. Tools to Help You Sell Against Competitors 1 Page Sales Sheets Symplicity Design Rationale PPT Materials available on the CVG Learning System, under Resource Library, MyVascular, and the MDT RDN iPad app.

  27. St Jude Medical Competitive Info Pack Section 5: Objection Handling

  28. Objection Handling- Efficacy The EnligHTN™ system is more effective than the Symplicity™ system at 6 months. • You can answer this objection in several ways. • It is clinically inappropriate to compare the EnligHTN-1 study to the SYMPLICITYHTN studies given the differences in study design, patient types, baseline characteristics, BP measurements, and patient numbers. This was not a head to head trial. • EnligHTN-1 is only a single arm study with only 46 patients. • SYMPLICITY HTN-1 and SYMPLICITY HTN-2 are multi-center studies in over 200 patients. • SYMPLICITY HTN-1 is a multi-center study in 153 patients with long term data out to 3 years. • SYMPLICITY HTN-2 is a randomized control study in 106 patients and has shown superior results compared to medication alone. The SYMPLICITY HTN-2 study showed a BP change of -32/-12 mmHg at 6 months in the treatment groupwith data out to 3 years. • SYMPLICITY HTN data are specific to the Symplicity™ RDN system. • Probing questions you can ask. • How important is long term safety and sustained blood pressure reduction to you and your patients? • How do you feel about using a system with results out to 3 years versus a system with only 18 months of data?

  29. Objection Handling- Efficacy The EnligHTN-1 study showed a more rapid BP reduction than the Symplicity studies at 1 month. • You can answer this objection in several ways. • EnligHTN-1 is a single arm study in only 46 patients and it is inappropriate to make cross trial comparisons. • For example, in the published full cohort (n=153) of the SYMPLICITY HTN-1 study, a mean drop of -20/-10 mmHg (Hypertension, 2011, H.Krum et al) at 1 month was seen while in the Symplicity Glucose paper (Circulation, 2011, F.Mahfoud et al) a drop of -28/-10 mmHg (n=37) at 1 month was recorded. • The EnligHTN-3 study showed at BP reduction of -19/-7 mmHg at 1 month. • Probing questions you can ask. • In light of the Circulation 2011 publication and the EnligHTN-3 data, would you agree that it’s far too early to make any judgment about the efficacy of the EnligHTN™ system and that it’s inappropriate to make cross-trial comparisons?

  30. Objection Handling- Speed The EnligHTN™ system is faster than the Symplicity™ system. • You can answer this objection in several ways. • In the SYMPLICITY HTN-1 study, the median procedure time was 38 min (from first ablation to energy delivery completion). • In EnligHTN-1, the median procedural time was 34 min (from first ablation to energy delivery completion). • No procedure time data has been presented in the EnligHTN-3 study • The ability to carefully select appropriate treatment spots with the Symplicity™catheter is of enormous benefit in the complex anatomies encountered in daily practice. • Probing questions you can ask. • What has led you to believe that the EnligHTN system is faster than the Symplicity system? • Have you considered the total procedure time including setup of the system, access, and positioning of the catheter, especially in tortuous anatomy?

  31. Objection Handling- Ease of Use and Predictability The EnligHTN™ system is easier to use and more precise or predictable than the Symplicity™ system. • You can answer this objection in several ways. • Keep in mind the EnligHTN™ catheter is 8F guide compatible and has a bulkier tip and may be more difficult to maneuver in both straight and tortuous renal arteries. • The EnligHTN system comes in 2 catheter sizes and requires proper artery sizing. • The safety profile of the EnligHTN system showed a number of minor complications, including 5 hematomas in 46 patients. • There are currently no data that link ablation patterns to efficacy. • Probing questions you can ask. • How often do you encounter tortuous renal arteries in your patients? • How important is it for you to have a one size fits all system versus one that requires additional inventory and proper renal artery sizing? • Would you rather use a 6F versus an 8F compatible system?

  32. Summary • On the positive side, the new St. Jude EnligHTN-1 data reinforces the value of renal denervation for treatment resistant hypertensive patients shown previously by the Symplicity™ Renal Denervation System. • The EnligHTN-1 data is short-term (12 months) with only 46 patients studied in a FIM. There are no long-term safety or randomized controlled data. • Mean procedure time for the EnligHTN™ system was 34 minutes from first ablation to last. (Data presented at TCT 2012) • Predictable placement of the EnligHTN four electrode array showed no demonstrated benefit to BP change at 6 month primary endpoint. • Large 8F guide catheter sheath compatibility may increase access site complications (e.g. hematoma). • Catheter comes in 2 different sizes and requires proper sizing of the renal artery, making this a less efficient cath lab solution.

  33. Thank you for completing theSt Jude Medical Competitive Info Pack module.

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