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Trademarks may be registered and are the property of their respective owners. A reminder that this is a discussion of SYMPLICITY trial results and their.

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Presentation on theme: "Trademarks may be registered and are the property of their respective owners. A reminder that this is a discussion of SYMPLICITY trial results and their."— Presentation transcript:

1 Trademarks may be registered and are the property of their respective owners. A reminder that this is a discussion of SYMPLICITY trial results and their implications for the future of RDN. Today’s discussion may regard information or indications not evaluated by regulatory authorities in your geography. Always refer to the Instructions for Use prior to using the Symplicity renal denervation system. Investigational use only in the USA © 2014 Medtronic, Inc. All rights reservedUC201406133IE 3/14 Medtronic RDN Global Symplicity Registry (GSR)

2 Trademarks may be registered and are the property of their respective owners. A reminder that this is a discussion of SYMPLICITY trial results and their implications for the future of RDN. Today’s discussion may regard information or indications not evaluated by regulatory authorities in your geography. Always refer to the Instructions for Use prior to using the Symplicity renal denervation system. Investigational use only in the USA © 2014 Medtronic, Inc. All rights reservedUC201406133IE 3/14 Key Takeaways Six-month results confirm the procedural safety with the Symplicity TM system in the largest real-world population studied. The Symplicity TM system significantly reduced both office and ambulatory BP from baseline. It will be important to reconcile the results from this real-world registry with those of SYMPLICITY HTN-3, which included randomization, blinding, sham control, BP inclusion criteria, antihypertensive-drug treatment intensity, and an African American cohort.

3 Trademarks may be registered and are the property of their respective owners. A reminder that this is a discussion of SYMPLICITY trial results and their implications for the future of RDN. Today’s discussion may regard information or indications not evaluated by regulatory authorities in your geography. Always refer to the Instructions for Use prior to using the Symplicity renal denervation system. Investigational use only in the USA © 2014 Medtronic, Inc. All rights reservedUC201406133IE 3/14 6M3Y2Y1Y Follow-up schedule 3M 4Y 5Y * Limited to resistant hypertension only 231 international sites in 37 countries Min. 10% randomly assigned to 100% monitoring Global Symplicity Registry (GSR) Consecutive patients treated in real-world population 5000 patients GREAT Registry N = 1000 Korea Registry* N = 102 South Africa Registry* N = 400 Canada and Mexico* Rest of GSR N ≈ 3500

4 Trademarks may be registered and are the property of their respective owners. A reminder that this is a discussion of SYMPLICITY trial results and their implications for the future of RDN. Today’s discussion may regard information or indications not evaluated by regulatory authorities in your geography. Always refer to the Instructions for Use prior to using the Symplicity renal denervation system. Investigational use only in the USA © 2014 Medtronic, Inc. All rights reservedUC201406133IE 3/14 Patient Disposition

5 Trademarks may be registered and are the property of their respective owners. A reminder that this is a discussion of SYMPLICITY trial results and their implications for the future of RDN. Today’s discussion may regard information or indications not evaluated by regulatory authorities in your geography. Always refer to the Instructions for Use prior to using the Symplicity renal denervation system. Investigational use only in the USA © 2014 Medtronic, Inc. All rights reservedUC201406133IE 3/14 All Patients (N = 1000) SBP ≥160 mm Hg and Ambulatory SBP ≥135* mm Hg (N = 327) Gender (% male)61.2%63.9% Age (years)60.7 ± 12.061.0 ± 10.9 BMI (kg/m 2 )30.5 ± 5.530.9 ± 5.5 Current smoking10.0%11.0% History of cardiac disease50.5%52.9% Renal impairment (eGFR <60 mL/min/1.73 m 2 ) 23.4%27.9% Sleep apnea (AHI≥5) 4.2%5.9% Diabetes, type 13.2% 2.5% Diabetes, type 238.5% 42.6% 1 comorbidity39.7%36.7% 2 comorbidities35.5%34.6% 3+ comorbidities24.6%28.4% * With ≥3 antihypertensive medication classes Baseline Patient Characteristics

6 Trademarks may be registered and are the property of their respective owners. A reminder that this is a discussion of SYMPLICITY trial results and their implications for the future of RDN. Today’s discussion may regard information or indications not evaluated by regulatory authorities in your geography. Always refer to the Instructions for Use prior to using the Symplicity renal denervation system. Investigational use only in the USA © 2014 Medtronic, Inc. All rights reservedUC201406133IE 3/14 All Patients (N = 1000) SBP ≥160 mm Hg and Ambulatory SBP ≥135 mm Hg* (N = 327) Antihypertensive medication class4.5 ± 1.34.7 ± 1.2 Beta-blockers78.9%81.0% ACE inhibitors33.8%38.5% Angiotensin receptor blockers67.3%67.9% Calcium channel blockers76.3%78.9% Diuretics78.2%79.8% Aldosterone antagonists21.1%19.3% Spironolactone18.6%15.9% Alpha-adrenergic blockers35.2%40.1% Direct-acting vasodilators15.1%19.0% Centrally acting sympatholytics33.2%37.6% Direct renin inhibitor 7.4% 7.7% Antihypertensive Medication Use *With ≥3 antihypertensive medication classes.

7 Trademarks may be registered and are the property of their respective owners. A reminder that this is a discussion of SYMPLICITY trial results and their implications for the future of RDN. Today’s discussion may regard information or indications not evaluated by regulatory authorities in your geography. Always refer to the Instructions for Use prior to using the Symplicity renal denervation system. Investigational use only in the USA © 2014 Medtronic, Inc. All rights reservedUC201406133IE 3/14 HTN-3 RDN Arm (N = 364) GSR All Patients (N = 1000) GSR Office SBP ≥160 mm Hg and ABPM ≥ 135* mm Hg (N=327) MAE1.4%0.8%1.3% At 6 months Death0.6%0.4%0.3% New-onset end-stage renal disease0.0%0.2%0.3% Significant embolic event resulting in end-organ damage 0.3%0.0% Renal artery re-intervention0.0%0.2%0.0% Vascular complication0.3%0.4%0.7% Hypertensive crisis/emergency2.6%1.0%1.7% New renal artery stenosis >70%0.3%0.0% Safety in HTN-3 and GSR *With ≥3 antihypertensive medication classes.

8 Trademarks may be registered and are the property of their respective owners. A reminder that this is a discussion of SYMPLICITY trial results and their implications for the future of RDN. Today’s discussion may regard information or indications not evaluated by regulatory authorities in your geography. Always refer to the Instructions for Use prior to using the Symplicity renal denervation system. Investigational use only in the USA © 2014 Medtronic, Inc. All rights reservedUC201406133IE 3/14 Change in Office SBP at 6 Months for GSR and SYMPLICITY HTN-3 Patients

9 Trademarks may be registered and are the property of their respective owners. A reminder that this is a discussion of SYMPLICITY trial results and their implications for the future of RDN. Today’s discussion may regard information or indications not evaluated by regulatory authorities in your geography. Always refer to the Instructions for Use prior to using the Symplicity renal denervation system. Investigational use only in the USA © 2014 Medtronic, Inc. All rights reservedUC201406133IE 3/14 Change in Office SBP at 6 Months for GSR and Non–African American Patients in SYMPLICITY HTN-3

10 Trademarks may be registered and are the property of their respective owners. A reminder that this is a discussion of SYMPLICITY trial results and their implications for the future of RDN. Today’s discussion may regard information or indications not evaluated by regulatory authorities in your geography. Always refer to the Instructions for Use prior to using the Symplicity renal denervation system. Investigational use only in the USA © 2014 Medtronic, Inc. All rights reservedUC201406133IE 3/14 Change in Ambulatory SBP for GSR and SYMPLICITY HTN-3 Patients

11 Trademarks may be registered and are the property of their respective owners. A reminder that this is a discussion of SYMPLICITY trial results and their implications for the future of RDN. Today’s discussion may regard information or indications not evaluated by regulatory authorities in your geography. Always refer to the Instructions for Use prior to using the Symplicity renal denervation system. Investigational use only in the USA © 2014 Medtronic, Inc. All rights reservedUC201406133IE 3/14 Distribution of SBP in Patients With Office SBP≥160 mm Hg and Ambulatory SBP ≥135 mm Hg* at Baseline

12 Trademarks may be registered and are the property of their respective owners. A reminder that this is a discussion of SYMPLICITY trial results and their implications for the future of RDN. Today’s discussion may regard information or indications not evaluated by regulatory authorities in your geography. Always refer to the Instructions for Use prior to using the Symplicity renal denervation system. Investigational use only in the USA © 2014 Medtronic, Inc. All rights reservedUC201406133IE 3/14 Excellent procedural and clinical safety profile in the largest data set of real-world RDN patients to date. Significant reductions in both office and ambulatory BP from baseline. –Differences from SYMPLICITY HTN-3 include randomization, blinding, sham control, BP inclusion criteria, antihypertensive-drug treatment intensity, and an African American cohort in HTN-3. –Despite the limitations of comparing a registry with a randomized, blinded, controlled study, the reduction in blood pressure is numerically larger in the GSR at 6 months after treatment. –Due to the nature of registry studies, it is difficult to account for the magnitude of a possible placebo effect in GSR. LBCT Conclusions

13 Trademarks may be registered and are the property of their respective owners. A reminder that this is a discussion of SYMPLICITY trial results and their implications for the future of RDN. Today’s discussion may regard information or indications not evaluated by regulatory authorities in your geography. Always refer to the Instructions for Use prior to using the Symplicity renal denervation system. Investigational use only in the USA © 2014 Medtronic, Inc. All rights reservedUC201406133IE 3/14 Medtronic Next Steps Medtronic will continue to provide access to the Symplicity™ system in countries where it has regulatory approval and will continue to support a global hypertension clinical program. Medtronic will continue to enroll in the Global SYMPLICITY Registry. Our detailed analyses of SYMPLICITY HTN-3 suggest that further investigation is warranted; Medtronic is in discussions with the FDA to determine the path forward for the next US IDE trial. In light of the results of the SYMPLICITY HTN-3 trial, Medtronic will discontinue the already suspended SYMPLICITY HTN-4 trial. Medtronic will consult with local regulatory bodies to determine the future of the HTN-Japan and HTN-India clinical studies. Medtronic will continue to pursue its studies in other disease states, including AF, CKD, HF, etc.

14 Trademarks may be registered and are the property of their respective owners. A reminder that this is a discussion of SYMPLICITY trial results and their implications for the future of RDN. Today’s discussion may regard information or indications not evaluated by regulatory authorities in your geography. Always refer to the Instructions for Use prior to using the Symplicity renal denervation system. Investigational use only in the USA © 2014 Medtronic, Inc. All rights reservedUC201406133IE 3/14 www.medtronic.com www.medtronicRDN.com Latin America Medtronic USA, Inc. Doral Corporate Center II 3750 NW 87th Avenue, Suite 700 Miami, FL 33178 USA Tel: 305.500.9328 Fax: 786.709.4244 Asia Pacific Medtronic Intl. Ltd. 49 Changi South Avenue 2 Nasco Tech Center Singapore 486056 Singapore Tel: 65.6436.5000 Fax: 65.6776.6335 Canada Medtronic of Canada Ltd. 99 Hereford Street Brampton, Ontario L6Y0R3 Canada Tel: 905.460.3800 Fax: 905.460.3998 Toll-free: 800.268.5346 Europe Medtronic Intl. Trading SARL Route du Molliau 31 Case Postale CH-1131 Tolochenaz Switzerland Tel: 41.21.802.7000 Fax: 41.21.802.7900 United States Medtronic USA, Inc. 3576 Unocal Place Santa Rosa, CA 95403 USA Tel: 707.525.0111 LifeLine Customer Support Tel: 877.526.7890 Tel: 763.526.7890 Product Services Tel: 888.283.7868 Fax: 800.838.3103

15 Trademarks may be registered and are the property of their respective owners. A reminder that this is a discussion of SYMPLICITY trial results and their implications for the future of RDN. Today’s discussion may regard information or indications not evaluated by regulatory authorities in your geography. Always refer to the Instructions for Use prior to using the Symplicity renal denervation system. Investigational use only in the USA © 2014 Medtronic, Inc. All rights reservedUC201406133IE 3/14 Appendix

16 Trademarks may be registered and are the property of their respective owners. A reminder that this is a discussion of SYMPLICITY trial results and their implications for the future of RDN. Today’s discussion may regard information or indications not evaluated by regulatory authorities in your geography. Always refer to the Instructions for Use prior to using the Symplicity renal denervation system. Investigational use only in the USA © 2014 Medtronic, Inc. All rights reservedUC201406133IE 3/14 Expanded results presented at the European Society of Cardiology Annual Meeting, 2013. P < 0.01 for  from baseline for all time points. Data is reported only on the patients available at each time point. SYMPLICITY HTN-1: Significant, Sustained BP Reduction to 3 Years 6 Months (N = 144) 1 Year (N = 132) 2 Years (N = 105) 3 Years (N = 88) Systolic Diastolic

17 Trademarks may be registered and are the property of their respective owners. A reminder that this is a discussion of SYMPLICITY trial results and their implications for the future of RDN. Today’s discussion may regard information or indications not evaluated by regulatory authorities in your geography. Always refer to the Instructions for Use prior to using the Symplicity renal denervation system. Investigational use only in the USA © 2014 Medtronic, Inc. All rights reservedUC201406133IE 3/14 SYMPLICITY HTN-2: BP Reductions Sustained to 3 Years Sustained Reductions in the Pooled (RDN and Crossover) Group* P <0.01 at all time points ∆ From Baseline to 36 Months (mm Hg) 30 Months N = 69 24 Months N = 69 6 Months N = 84 12 Months N = 80 18 Months N = 74 36 Months N = 40 *Crossover patients only had 30 months post-procedure data. Whitbourn, TCT 2013 Systolic Diastolic

18 Trademarks may be registered and are the property of their respective owners. A reminder that this is a discussion of SYMPLICITY trial results and their implications for the future of RDN. Today’s discussion may regard information or indications not evaluated by regulatory authorities in your geography. Always refer to the Instructions for Use prior to using the Symplicity renal denervation system. Investigational use only in the USA © 2014 Medtronic, Inc. All rights reservedUC201406133IE 3/14 Multiple Unblinded Trials Show RDN Lowers Blood Pressure N=153 N=102 N=313 N=109 N=346 N=63 N=15 Published Sources: 1.Lancet 2009 2.Lancet 2010 3.TCT 2013 4.Journal of Human Hypertension 2013 5.Circulation 2013 6.Clin Res Cardiol 2013 7.J Am Soc Nephrol 2012 8.Eur Heart J 2013 9.TCT 2013 10.Eurointervention 2013 11.EuroIntervention 2013 N=46 N=146 N=47 N=15 Medtronic EnligHTN/St Jude Vessix/Boston Sci. Maya/Covidien Recor


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