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Boston Scientific ( Vessix ) Competitive Info Pack

Boston Scientific ( Vessix ) 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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Boston Scientific ( Vessix ) Competitive Info Pack

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  1. Boston Scientific (Vessix) 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 Vessix 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 By the end of this module, you will be better prepared to: • Describe the V2 Renal Denervation System™ • Articulate the key clinical data generated by the V2 Renal Denervation System™ • Compare and contrast V2 Renal Denervation System™ with the Symplicity™ Renal Denervation System • Effectively handle sales objections

  5. Boston Scientific (Vessix) Competitive Info Pack Section 1: Company Overview

  6. Boston Scientific (Vessix) Overview • Boston Scientific is a top competitor and will leverage its existing cardiovascular, peripheral vascular, and cardiac rhythm management business to enter the RDN market.

  7. Vessix Launch Timeline and Clinical Trial Status V2 Renal Denervation System™ Received CE Mark Approval in May 2012 • Boston Scientific Acquired Vessix Vascular in November 2012 and is now part of the Peripheral Interventions business • Commercialization underway in Europe and Australia Presented at TCT2013

  8. Boston Scientific (Vessix) Competitive Info Pack Section 2: Product Overview

  9. Product Overview RDN Technology Presented at PCR 2013 and TCT 2013

  10. Knowledge Check • Can you use a single size Vessix catheter to treat all arteries between 3-7mm in diameter? • The electrodes on the catheter are monopolar. • What feedback is not displayed on the generator display? • Is the system power or temperature controlled, and at what target setting? Yes No True False Treatment Time Temperature Power Temperature controlled at 75C Power controlled at 8W Temperature controlled at 68C Power controlled at 6W

  11. Knowledge Check • Can you use a single size Vessix catheter to treat all arteries between 3-7mm in diameter? • The electrodes on the catheter are monopolar. • What feedback is not displayed on the generator display? • Is the system power or temperature controlled, and at what target setting? Yes No True False Treatment Time Temperature Power Temperature controlled at 75C Power controlled at 8W Temperature controlled at 68C Power controlled at 6W

  12. Boston Scientific (Vessix) Competitive Info Pack Section 3: Clinical Overview

  13. Clinical Overview REDUCE-HTN Overview Presented at TCT2013

  14. Clinical Overview REDUCE-HTN Baseline Data presented at TCT 2013

  15. Clinical Overview REDUCE-HTN Clinical Results REDUCE-HTN 12 Month Follow-up Data - Office BP Summary of Data from REDUCE-HTN • Baseline BP of 182/100 mmHg and 5.2 meds • Responder rate (>10 mmHg drop in BP): 76% at 6 months, 85% at 12 months • 5.5% (8/146) procedure related adverse events among 146 patients: • Hematoma (1) • Bilateral flank pain (1) • Vomiting (1) • Access site infection (2) • Pseudoaneurysmat access site (1) • Femoral artery thrombus (1) • Renal artery stenosis requiring stenting (1) Presented at TCT2013

  16. Clinical Overview REDUCE-HTN Clinical Results REDUCE-HTN 12 Month Follow-up Data - ABPM Presented at TCT2013

  17. Clinical Overview Key Points • The REDUCE-HTN study is a non-randomized single-arm study across sites in the EU and ANZ • This data have not been published in any peer reviewed journal • This is a small trial with 41 patients with 6 months follow-up and only 10 patients with 12 months follow-up • The post-market study will allow treatment of renal arteries 3-7mm in diameter and accessory arteries • No safety events have been reported at this point

  18. Boston Scientific (Vessix) Competitive Info Pack Section 4: Selling Against the V2 Renal Denervation System

  19. Selling Against V2 Renal Denervation System™ Strengths Weaknesses Threats Opportunities

  20. 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.

  21. Boston Scientific (Vessix) Competitive Info Pack Section 5: Objection Handling

  22. Objection Handling- Efficacy Vessix’s V2 Renal Denervation 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 REDUCE-HTN study to the SYMPLICITY HTN studies given the differences in study design, patient types, baseline characteristics, BP measurements, and patient numbers. This was not a head to head trial. • REDUCE-HTN is a single arm, non-randomized study with only 6 patients at the 6 month primary endpoint. • 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 with 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 12 months of data in less than 50 patients?

  23. Objection Handling- Speed Vessix’s V2 Renal Denervation System is faster than the Symplicity system. • You can answer this objection in several ways. • Vessixhas not presented any data on average procedure times from their REDUCE-HTN FIM study. There is also lack of long term data to support the feature of shorter ablation time with the V2 system. • The Vessix catheter requires 4 different balloon sizes to treat a range of renal arteries 3-7mm in diameter. This will require proper sizing of the renal arteries, may require multiple balloons for each renal artery, and will require stocking of multiple sizes, potentially adding to the total procedure time for each case. • The Vessix catheter is 9F guide catheter compatible and may be difficult to maneuver, especially in tortuous anatomies, and may lead to higher access site complications (e.g. hematoma). • The ability to carefully select appropriate treatment spots with the Symplicity™ catheter is of enormous benefit in the tortuous anatomies encountered in daily practice. • Probing question you can ask. • Have you considered the total procedure time including setup of the system, access, and positioning of the catheter, especially in tortuous anatomy?

  24. Objection Handling- Ease of Use and Predictability Vessix’s V2 Renal Denervation System is easier to use and more precise or predictable than the Symplicity system. • You can answer this objection in several ways. • The Vessix catheter is 9F guide catheter compatible and may be difficult to maneuver, especially in tortuous anatomies, and may lead to a higher rate of access site complications (e.g. hematoma). • The Vessix catheter requires 4 different balloon sizes to treat renal arteries 3-7mm in diameter. This will require proper sizing of the renal arteries, may require multiple balloons for each renal artery, and will require stocking of multiple sizes. • 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 9F compatible system?

  25. Objection Handling What is the difference between monopolar and bipolar systems? • You can answer this question in several ways. • Monopolar systems, such as the Symplicity™ system, require a patient return electrode (also known as a grounding pad). Bipolar systems, such as the Boston Scientific Vessix™ system, do not require a grounding pad. • There is currently no published evidence showing that bipolar systems result in greater or less efficacy and safety than monopolarsystems. There have been no head to head studies comparing the Symplicity system to the Vessix system. • Keep in mind that the Vessix system is, • 9F guide catheter compatible and may be difficult to maneuver, especially in tortuous anatomies, and may lead to a higher rate of access site complications (e.g. hematoma). • Requires occlusion of the renal artery • Requires multiple balloon sizes to treat a range of renal arteries 3-7mm in diameter, requiring proper artery sizing , and adding to inventory and procedural costs • Probing questions you can ask. • What have you heard about bipolar systems? Why do you believe bipolar systems are better than monopolar systems? • How concerned are you about using an 8F compatible system versus a 6F compatible system? • How often do you encounter tortuous anatomies?

  26. Objection Handling Bipolar systems result in less pain. • You can answer this objection in several ways. • There is no published evidence showing bipolar systems result in less pain or require less pain medications during the procedure than monopolar systems. There have been no head to head studies comparing Symplicity to the Vessix system. • There can also be pain with bipolar systems since the renal nerves are being ablated. To the extent that there are anecdotal reports of less pain experienced with bipolar systems, this is likely due to the shorter ablation time and not due to the bipolar electrode configuration. • Keep in mind that the Vessix system is still • 9F guide catheter compatible and may be difficult to maneuver, especially in tortuous anatomies, and may lead to a higher rate of access site complications (e.g. hematoma). • Requires occlusion of the renal artery • Requires multiple balloon sizes to treat a range of renal arteries 3-7mm in diameter, requiring proper artery sizing , and adding to inventory and procedural costs • Probing questions you can ask. • What experience have you had with bipolar systems? • What pain medications are you using in your RDN procedures? Do your patients complain about pain during the procedure?

  27. Objection Handling Bipolar systems allow me to treat smaller arteries, such as accessory arteries, down to 3mm in diameter. • You can answer this objection in several ways. • The type of RF energy delivery, whether bipolar or monopolar, does not impact the size of artery that can be treated. The overall system design will dictate the type of anatomy that can be treated. • There is no published evidence on treating accessory arteries, nor is there data showing treatment of accessory arteries would result in additional efficacy or safety. • Given the Vessix catheter is 9F compatible, it may be difficult to maneuver the catheter into arteries <4mm in diameter. • Probing questions you can ask. • How often do you encounter renal arteries that are <4mm in diameter? • How much oversizing can arteries tolerate even at low pressures? • Do you believe that treating accessory arteries will result in efficacy? • How difficult do you think it will be to maneuver a 9F compatible device into a 3mm diameter artery?

  28. Objection Handling Bipolar systems do not penetrate as deep as monopolar systems. • You can answer this objection in several ways. • There is no published evidence showing the depth of lesions created with the Vessix bipolar system compared to monopolar systems. • Probing questions you can ask. • How important to you are the clinical outcomes relative to the different technologies available for RDN?

  29. Summary • On the positive side, the Vessix REDUCE -HTN data reinforces the value of renal denervation for treatment resistant hypertensive patients shown previously by the Symplicity™ Renal Denervation System • The data on Vessix’s V2 Renal Denervation System have not been peer reviewed; and the data are very limited with 6 month results in 41 patients and 12 month results in only 10 patients. • There are no long-term or randomized controlled data. • Large 9F guide catheter compatibility may increase access site complications (e.g. hematoma). • Catheter comes in 4 different sizes (4, 5, 6, 7mm in diameter) and requires proper sizing of the renal artery, making this a less efficient cath lab solution • Occlusive balloon interrupts blood flow and may create unwanted side effects

  30. Thank you for completing theBoston Scientific (Vessix) Competitive Info Pack module.

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