Suku Thambar

For distribution only in markets where the Symplicity™ renal denervation system is approved. Not for distribution in the USA or Japan.
Trademarks may be registered and are the property of their respective owners. © 2012 Medtronic, Inc. All rights reserved. UC201205567EE

Renal Denervation
c

• Single largest contributor to death
worldwide
30%
Untreated

35%
Treated but
Uncontrolled

35%
Treated &
Controlled

• Every 20/10 mmHg increase in BP
correlates with a doubling of 10-year
cardiovascular mortality

• Dramatically increases risk of stroke,
heart attack, heart failure, & kidney failure c
• Only half of all treated hypertensives are
controlled to established BP targets
• High prevalence:
• Affects 1 in 3 adults
• 1B people worldwide  1.6 B by 2025

Chobanian et al. Hypertension. 2003;42(6):1206–1252.

For distribution only in markets where the Symplicity™ renal denervation system is approved. Not for distribution in the USA or Japan.
Trademarks may be registered and are the property of their respective owners. © 2012 Medtronic, Inc. All rights reserved. UC201205567EE

Hypertension Epidemiology

2

Kidney as Recipient of Sympathetic Signals

Renal Efferent
Nerves

↑ Renin Release  RAAS activation
↑ Sodium Retention
↓ Renal Blood Flow

For distribution only in markets where the Symplicity™ renal denervation system is approved. Not for distribution in the USA or Japan.
Trademarks may be registered and are the property of their respective owners. © 2012 Medtronic, Inc. All rights reserved. UC201205567EE

Renal Sympathetic Activation: Efferent Nerves

3

UC201205567EE Renal Sympathetic Activation: Afferent Nerves 4 .Kidney as Origin of Central Sympathetic Drive Vasoconstriction Atherosclerosis Insulin Resistance Sleep Disturbances Renal Afferent Nerves Hypertrophy Arrhythmia Oxygen Consumption ↑ Renin Release  RAAS activation ↑ Sodium Retention ↓ Renal Blood Flow For distribution only in markets where the Symplicity™ renal denervation system is approved. Inc. Trademarks may be registered and are the property of their respective owners. Not for distribution in the USA or Japan. All rights reserved. © 2012 Medtronic.

All rights reserved. Inc. © 2012 Medtronic. UC201205567EE Renal Nerve Anatomy 5 . Trademarks may be registered and are the property of their respective owners.• Nerves arise from T10-L2 • The nerves arborize around the artery and primarily lie within the adventitia Vessel Lumen Med ia Adventi tia 5 Renal Nerve s For distribution only in markets where the Symplicity™ renal denervation system is approved. Not for distribution in the USA or Japan.

5 mm. Trademarks may be registered and are the property of their respective owners. Inc. Not for distribution in the USA or Japan. All rights reserved.g. UC201205567EE Renal Nerve Anatomy Allows a Catheter-Based Approach 6 . • Renal artery access via standard interventional technique • 4-6 two-minute treatments per artery • Proprietary RF generator – Automated – Low power – Built-in safety algorithms For distribution only in markets where the Symplicity™ renal denervation system is approved.Spacing of e. © 2012 Medtronic.

US & AU) Symplicity HTN-1 Symplicity HTN2 Initial RCT (EU & AU) SYMPLICITY HTN-3 US Pivotal Trial (US) Global SYMPLICITY Registry (Approved Regions) Expand HTN Indication (Approved Regions) Post-Market Registry (US) Pilot Studies in New Indications (Approved Regions) SYMPLICITY HF Trials under way c For distribution only in markets where the Symplicity™ renal denervation system is approved. Not for distribution in the USA or Japan. Trademarks may be registered and are the property of their respective owners.First-in-Man (AU) Series of Pilot Studies (EU. All rights reserved. Inc. © 2012 Medtronic. UC201205567EE SYMPLICITY Clinical Trial Program follows over 5000 patients across multiple indications .

UC201205567EE Symplicity HTN-1 8 .57:911-917. All rights reserved.373:1275-1281 Hypertension. © 2012 Medtronic.) For distribution only in markets where the Symplicity™ renal denervation system is approved. Trademarks may be registered and are the property of their respective owners. eGFR ≥ 45 mL/min) . non-randomized -Cohort of 45 patients with resistant HTN (SBP ≥160 mmHg on ≥3 anti-HTN drugs. 2011.12-month data \ Expanded Cohort* – This Report (Symplicity HTN-1): -Expanded cohort of patients (n=153) -36-month follow-up *Expanded results presented at the American College of Cardiology Annual Meeting 2012 (Krum. H. Not for distribution in the USA or Japan. Initial Cohort – Reported in the Lancet.Lancet. Inc. 2009. 2009: -First-in-man. including a diuretic.

Inc.73m2) 83 ± 20 Baseline BP (mmHg) 176/98 ± 17/15 Number of anti-HTN meds (mean) Diuretic (%) Aldosterone blocker(%) 5. For distribution only in markets where the Symplicity™ renal denervation system is approved. All rights reserved. Trademarks may be registered and are the property of their respective owners. © 2012 Medtronic.Demographics Co-morbidities Blood Pressure Age (years) 57 ± 11 Gender (% female) 39% Race (% non-Caucasian) 5% Diabetes Mellitus II (%) 31% CAD (%) 22% Hyperlipidemia (%) 68% eGFR (mL/min/1. Hypertension. Not for distribution in the USA or Japan.4 95% 22% ACE/ARB (%) 91% Direct Renin Inhibitor 14% Beta-blocker (%) 82% Calcium channel blocker (%) 75% Centrally acting sympatholytic (%) 33% Vasodilator (%) 19% Alpha-1 blocker 19% Symplicity HTN-1 Investigators.1 ± 1. UC201205567EE Baseline Patient Characteristics (n=153) 9 .57:911-917. 2011.

Trademarks may be registered and are the property of their respective owners. UC201205567EE Brief Procedure with a Low Complication rate (n=153) 10 .• 38 minute median procedure time – Average of 4 ablations per artery • Intravenous narcotics & sedatives used to manage pain during delivery of RF energy • No catheter or generator malfunctions • No major complications • Minor complications 4/153: – 1 renal artery dissection during catheter delivery (prior to RF energy).57:911-917. © 2012 Medtronic. For distribution only in markets where the Symplicity™ renal denervation system is approved. Inc. no sequelae – 3 access site complications. Not for distribution in the USA or Japan. All rights reserved. 2011. Hypertension. treated without further sequelae Symplicity HTN-1 Investigators.

Inc.01 for ∆ from BL for all time points *Expanded results presented at the American College of Cardiology Annual Meeting 2012 (Krum. Trademarks may be registered and are the property of their respective owners. © 2012 Medtronic. H.) For distribution only in markets where the Symplicity™ renal denervation system is approved. Not for distribution in the USA or Japan. All rights reserved. UC201205567EE Symplicity HTN-1: BP Reductions through 3 years .BP change (mmHg) P<0.

Trademarks may be registered and are the property of their respective owners. Inc. UC201205567EE Symplicity HTN-1: Percentage Responders Over Time .Responder was defined as an office SBP reduction ≥ 10 mmHg (n=143) (n=148) (n=144) (n=130) *Expanded results presented at the American College of Cardiology Annual Meeting 2012 (Krum. H. © 2012 Medtronic.) (n=107) (n=59) (n=24) (n=24) For distribution only in markets where the Symplicity™ renal denervation system is approved. All rights reserved. Not for distribution in the USA or Japan.

UC201205567EE Symplicity HTN-1: Response Rate Among Non-responders at 1 Month (n=45) . © 2012 Medtronic. All rights reserved.Responder was defined as an office SBP reduction ≥ 10 mmHg (n=45) (n=45) (n=44) *Expanded results presented at the American College of Cardiology Annual Meeting 2012 (Krum. Inc. Trademarks may be registered and are the property of their respective owners.) (n=39) (n=17) (n=8) For distribution only in markets where the Symplicity™ renal denervation system is approved. Not for distribution in the USA or Japan. H.

Not for distribution in the USA or Japan.) For distribution only in markets where the Symplicity™ renal denervation system is approved. UC201205567EE Symplicity HTN-1: Chronic Safety Out to 3 Years . © 2012 Medtronic. Trademarks may be registered and are the property of their respective owners. All rights reserved. all unrelated to the device or therapy No hypotensive events that required hospitalization There were no observed changes in mean electrolytes or eGFR *Expanded results presented at the American College of Cardiology Annual Meeting 2012 (Krum.• • • • • One progression of a pre-existing stenosis unrelated to RF treatment (stented without further sequelae) One new moderate stenosis which was not haemodynamically relevant and no treatment 3 deaths within the follow-up period. H. Inc.

© 2012 Medtronic. Inc. Trademarks may be registered and are the property of their respective owners. UC201205567EE Conclusions from Symplicity HTN-1 . All rights reserved. H. and baseline renal function) • No late adverse events were seen *Expanded results presented at the American College of Cardiology Annual Meeting 2012 (Krum.) For distribution only in markets where the Symplicity™ renal denervation system is approved. diabetes status. Not for distribution in the USA or Japan.• The magnitude of clinical response is significant and sustained through 3 years • Increasing responder rates indicate: – no loss of treatment effect out to 36 months – BP non-response at 6 months does not predict failure to respond at 12 months or later • The treatment effect was consistent across subgroups (age.

clinical trial Patients: 106 patients randomized 1:1 to treatment with renal denervation vs. 2010. All rights reserved. Inc. Not for distribution in the USA or Japan. © 2012 Medtronic. UC201205567EE Symplicity HTN-2 16 . 2010. randomized. For distribution only in markets where the Symplicity™ renal denervation system is approved. & New Zealand (67% were designated hypertension centers of excellence) Symplicity HTN-2 Investigators.376:1903-1909. controlled.Lancet. control Clinical Sites: 24 centers in Europe.376:1903-1909. Lancet. Australia. • • • Purpose: To demonstrate the effectiveness of catheter-based renal denervation for reducing blood pressure in patients with uncontrolled hypertension in a prospective. Trademarks may be registered and are the property of their respective owners.

France John Hunter Hospital. Zurich. Leipzig. Warsaw. Germany William Harvey Research Institute. Vincent’s Hospital. UK University Hospital Zurich. UC201205567EE Europe & Australia/NZ . Germany Universität Erlangen-Nürnberg. Paris. Murray Esler Universitätsklinikum des Saarlandes. 2010. Poland Hospital 12 de Octubre. Erlangen. Germany The John Paul II Hospital. Lancet. Düsseldorf. Latvia Assistance Publique des Hôpitaux de Paris. Germany The Alfred Hospital. Queen Mary University of London and Barts. Canterbury. Hôpital Européen Georges Pompidou. Brussels. Krakow. For distribution only in markets where the Symplicity™ renal denervation system is approved. Switzerland University of Glasgow. Germany CardioVascular Center Frankfurt. Australia Universitätsklinikum Essen. Poland Symplicity HTN-2 Investigators. Germany Universität zu Köln. Vienna. © 2012 Medtronic. Austria Samodzielna Pracownia Hemodynamiczna. Glasgow. Germany Universitätsklinikum Düsseldorf. UK Pauls Stradins Clinical University Hospital. Essen. Trademarks may be registered and are the property of their respective owners. Germany Kent and Canterbury Hospital. Lübeck. Not for distribution in the USA or Japan. Inc. Australia Cliniques Universitaires Saint-Luc. Auckland. Melbourne. Köln. New Zealand Herz-Zentrum Bad Krozingen.Participating Centers PI: Prof. London. Australia Universität Leipzig – Herzzentrum. Bad Krozingen. Belgium Universitaetsklinikum Schleswig-Holstein.376:1903-1909. Frankfurt. UK Auckland City Hospital. Germany Allgemeines Krankenhaus der Stadt Wien. All rights reserved. Riga. Madrid. Homburg. Newcastle. Melbourne. Spain St.

Inc.• Treatment-resistant HTN population Inclusion Criteria: – • BL OBP 178/97 mmHg – • 49 RDN.73m 2 (MDRD formula) Type 1 diabetes mellitus Contraindication to MRI Stenotic valvular heart disease for which reduction of BP would be hazardous MI. UC201205567EE Symplicity HTN-2 Trial c .2 • RDN and Control groups generally well-matched *MDRD.376:1903-1909. Lancet. 2010. © 2012 Medtronic. All rights reserved. Trademarks may be registered and are the property of their respective owners. or CVA in the prior 6 months For distribution only in markets where the Symplicity™ renal denervation system is approved. Office SBP ≥ 160 mmHg (≥ 150 mmHg with type II diabetes mellitus) Stable drug regimen of 3+ more anti-HTN medications Age 18-85 years Exclusion Criteria: – – – – – – Haemodynamically or anatomically significant renal artery abnormalities or prior renal artery intervention eGFR < 45 mL/min/1. Not for distribution in the USA or Japan. unstable angina.73m2 Symplicity HTN-2 Investigators. ml/min/1. 51 Control – • Age 58 years • BMI 31 kg/m² • 40% with Diabetes • eGFR 77* • Avg # meds 5.

16%)  Declined participation (n=10. Not for distribution in the USA or Japan. Trademarks may be registered and are the property of their respective owners. 5%)  Other exclusion criteria discovered after consent (n=8. Inc. © 2012 Medtronic. Prior to Randomisation (n=84) Randomised (n=106) Allocated to RDN n=52 Treated n=49 Analysable  BP < 160 at Baseline Visit (after 2-weeks of medication compliance confirmation) (n=36. 6mo Post-RDN (Crossover) n=9 For distribution only in markets where the Symplicity™ renal denervation system is approved. 19%)  Ineligible anatomy (n=30. 6-mo Post-RDN (Crossover) n=35 Not-per-protocol*.Assessed for Eligibility (n=190) Excluded During Screening. All rights reserved. UC201205567EE Symplicity HTN-2: Patient disposition . 4%) Allocated to Control n=54 Control n=51 Analysable Crossover n=46 2 LTFU 12-month post-RDN n=47 * Crossed-over with ineligible BP (<160 mmHg) Per protocol.

09 >0. ml/min/1.0 ± 0.23 n = 42 for RDN and n = 43 for Control. M.2 75 ± 15 178 ± 16 98 ± 17 5.3 128 ± 363 0. * Expanded results presented at the American College of Cardiology Annual Meeting 2012 (Esler.75 0.80 0.99 0. Wilcoxon rank-sum test for two independent samples used for between-group comparisons of UACR.73m2) Serum creatinine (mg/dL) Urine alb/creat ratio (mg/g)* Cystatin C (mg/L)† Heart rate (bpm) RDN (n = 52) Control (n = 54) p-Value 178 ± 18 97 ± 16 5.5 58 ± 12 35% 98% 31 ± 5 40% 19% 52% 77 ± 19 1. Not for distribution in the USA or Japan.3 ± 1.) For distribution only in markets where the Symplicity™ renal denervation system is approved.8 58 ± 12 50% 96% 31 ± 5 28% 7% 52% 86 ± 20 0. † n = 39 for RDN and n = 42 for Control.003 0.77 0. Inc.2 71 ± 15 0.97 0.22 0.2 109 ± 254 0.9 ± 0.99 0.8 ± 0. All rights reserved. © 2012 Medtronic.97 0. Trademarks may be registered and are the property of their respective owners.16 0.Baseline systolic BP (mmHg) Baseline diastolic BP (mmHg) Number anti-HTN medications Age Gender (female) (%) Race (Caucasian) (%) BMI (kg/m2) Type 2 diabetes Coronary artery disease Hypercholesterolemia eGFR (MDRD.12 >0.2 ± 1.9 ± 0.013 0. UC201205567EE RDN and Control Populations Well-matched.64 0. Severe Treatment Resistant Hypertensives .

The lesion was stented without further consequences One hospitalization prolonged in a crossover patient due to hypotension following the RDN procedure. All rights reserved. Not for distribution in the USA or Japan. anti-hypertensive medications decreased and patient discharge without further incident No radiofrequency-related renal artery stenosis or aneurysm occurred in either Randomised group Minor adverse events (full cohort) – – – – – 1 femoral artery pseudoaneurysm treated with manual compression 1 post-procedural drop in BP resulting in a reduction in medication 1 urinary tract infection 1 prolonged hospitalisation for evaluation of paraesthesias 1 back pain treated with pain medications and resolved after 1 month Expanded results presented at the American College of Cardiology Annual Meeting 2012 (Esler.• • • • One renal artery dissection from injection of contrast into renal artery wall during dye angiography. Inc. IV fluids administered. M. Trademarks may be registered and are the property of their respective owners. UC201205567EE Symplicity HTN-2: Procedural Safety . © 2012 Medtronic.) For distribution only in markets where the Symplicity™ renal denervation system is approved.

Primary Endpoint (6M post Randomisation) Latest Follow-up (12M post Randomisation) RDN (n= 47) ∆ from Baseline to 6 Months (mmHg) Systolic Diastolic Diastolic Systolic p <0. Inc.01 for  from baseline Latest Follow-up: •Control crossover (n = 35): -24/-8 mmHg (Analysis on patients with SBP ≥ 160 mmHg at 6 M) For distribution only in markets where the Symplicity™ renal denervation system is approved.01 for difference between RDN and Control Primary Endpoint: •84% of RDN patients had ≥10 mmHg reduction in SBP •10% of RDN patients had no reduction in SBP Expanded results presented at the American College of Cardiology Annual Meeting 2012 (Esler.) ∆ from Baseline to 12 Months (mmHg) Diastolic Systolic p <0. UC201205567EE Symplicity HTN-2: Primary Endpoint and Latest Follow-up . Not for distribution in the USA or Japan. © 2012 Medtronic. All rights reserved. Trademarks may be registered and are the property of their respective owners. M.

2% (5/33) Physicians were allowed to make changes to medications Once the 6 month primary endpoint was reached* *Further analysis of Medications is ongoing For distribution only in markets where the Symplicity™ renal denervation system is approved.9% (12/43) Increase (# Meds or Dose) 11.6% (8/43) Crossover (n=35) 6 months postRDN Decrease (# Meds or Dose) 18. © 2012 Medtronic. All rights reserved.RDN (n=47) 6 month 12 months Decrease (# Meds or Dose) 20. Not for distribution in the USA or Japan. UC201205567EE Symplicity HTN-2: Medication Changes at 6 and 12 Months Post-Renal Denervation .6% (5/43) 18.9% (9/43) 27. Inc.2% (6/33) Increase (# Meds or Dose) 15. Trademarks may be registered and are the property of their respective owners.

3 (n= 49) 77. © 2012 Medtronic.82±0. The Lancet.78 ± 0. Not for distribution in the USA or Japan. All rights reserved.17 (n=27) 0.RDN Treated at Randomisation N=47 eGFR Baseline 6 month 12 months 76.7 (n = 35) 89.9 ±19. For distribution only in markets where the Symplicity™ renal denervation system is approved.73m ) 2 Cystatin C (mg/L) Treated after 6-mo follow-up Crossover N=35 eGFR Baseline 6 month 12 months 88.73m ) 2 Cystatin C (mg/L) Symplicity HTN-2 Investigators.1±18. Trademarks may be registered and are the property of their respective owners. Inc. 2010.5 (n = 35) 85.8 ± 20.3 (n = 35) 0.3±19.2±17.91±0.16 (n=26) 0.98±0.2±18.36 (n=40) 0.8 (n=49) 78.89±0.20 (n=26) (ml/min/1.25 (n=38) 0.30 (n=38) (ml/min/1.98±0.4 (n=45) 0. UC201205567EE Symplicity HTN-2: Renal Function Results .

Not for distribution in the USA or Japan. © 2012 Medtronic. Catheter-based renal denervation is beneficial for patients with treatment-resistant essential hypertension. This therapeutic innovation. 2010. Inc. Symplicity HTN-2 Investigators. affirms the crucial relevance of renal nerves in the maintenance of BP in patients with hypertension. For distribution only in markets where the Symplicity™ renal denervation system is approved. resulted in significant reductions in BP. randomised trial in patients with treatment-resistant essential hypertension. based on the described neural pathophysiology of essential hypertension. The magnitude of BP reduction can be predicted to affect the development of hypertension-related diseases and mortality The technique was applied without major complications.376:1903-1909.• • • • • Catheter-based renal denervation. All rights reserved. done in a multicentre. UC201205567EE Symplicity HTN-2: Lancet Conclusions 25 . Lancet. Trademarks may be registered and are the property of their respective owners.

• 20 cases over the next 12 months. • Indication-Similar to trials • Reimbursement at least 2 years away. © 2012 Medtronic. Not for distribution in the USA or Japan. • Funded by Renal. • 18 months of “negotiations” with area to commence program. Radiology departments and 2 donors. Inc.• TGA approval in 2010-Renal Denervation. All rights reserved. For distribution only in markets where the Symplicity™ renal denervation system is approved. UC201205567EE JHH Clinical Program . Trademarks may be registered and are the property of their respective owners.

Trademarks may be registered and are the property of their respective owners. • All patients to be enrolled in Global Registry. Inc. For distribution only in markets where the Symplicity™ renal denervation system is approved. © 2012 Medtronic. All rights reserved. UC201205567EE JHH Clinical Program . Not for distribution in the USA or Japan.• Multi disciplinary clinic to finalize case selection.

Background • Female. For distribution only in markets where the Symplicity™ renal denervation system is approved. UC201205567EE Case study: JPB . Inc. type II diabetes. small calibre left RA <4mm. anxiety. omeprazole. 64 years of age. aspirin. Renal denervation procedure (8/3/10) • Angiogram: singles. © 2012 Medtronic. mild OSA. All rights reserved. glicazide. nicorandil. UAP. • Medications: enalapril. secondary causes excluded • IHD. prn nitrate. Not for distribution in the USA or Japan. metoprolol. • Hypertension > 10 years. Trademarks may be registered and are the property of their respective owners. metformin. simvastatin. Karvezide.

UC201205567EE Case study: JPB . © 2012 Medtronic. Trademarks may be registered and are the property of their respective owners. Not for distribution in the USA or Japan. Inc. All rights reserved.Results For distribution only in markets where the Symplicity™ renal denervation system is approved.

• Initial data derived from first generation catheter. For distribution only in markets where the Symplicity™ renal denervation system is approved. • Currently denervation is assumed at the end of the procedure. • Multi polar catheters may increase efficacy and reduce duration of procedure. All rights reserved. Inc. UC201205567EE The Future is Bright for RDN . Trademarks may be registered and are the property of their respective owners. © 2012 Medtronic. Not for distribution in the USA or Japan. • The ability to confirm denervation at the end of the procedure will improve efficacy.

Trademarks may be registered and are the property of their respective owners. UC201205567EE The Future is Bright for RDN . For distribution only in markets where the Symplicity™ renal denervation system is approved.• Every major catheter company will have a RDN system. Not for distribution in the USA or Japan. All rights reserved. Inc. • Other modes of ablation (ultrasound.cryo) will be developed. © 2012 Medtronic. • Indications for RDN will expand.

Siva Rajaratnam.• Renal Department. • Cardiology. • Radiology Department. Kerry Thomas and angio staff. Ajay Thakorlal.Peter Fletcher. c For distribution only in markets where the Symplicity™ renal denervation system is approved.Liz Holt. Eswari Vilayur. Barry Soans. Inc. Not for distribution in the USA or Japan.Ranjith Nanra. Melissa Chaplin. Trademarks may be registered and are the property of their respective owners. © 2012 Medtronic. UC201205567EE Acknowledgements . All rights reserved. Al Gillies.

© 2012 Medtronic.For distribution only in markets where the Symplicity™ renal denervation system is approved. Inc. Trademarks may be registered and are the property of their respective owners. UC201205567EE ISCHEMIA (ACC Inv Meet 25Mar12) . Not for distribution in the USA or Japan. All rights reserved.

Not for distribution in the USA or Japan. the optimal management approach for these patients is unknown. the 4-year mortality rate is >50% in patients with severe CKD (eGFR <30) or on haemodialysis. Most of the treatments aimed at reducing their CV events are therefore extrapolated from cohorts without CKD. Inc. For distribution only in markets where the Symplicity™ renal denervation system is approved. Design ISCHEMIA CKD would be conducted with the same screening. OMT alone (CON strategy). UC201205567EE ISCHEMIA Chronic Kidney Disease Companion Trial . Trademarks may be registered and are the property of their respective owners. ~80% of contemporary CAD trials exclude CKD/ESRD patients. Despite this. CKD patients are less likely to be prescribed statins and less likely to be referred for cardiac catheterization and revascularization. All rights reserved. ISCHEMIA CKD trial will randomize patients with severe CKD or those on haemodialysis and at least moderate ischemia on stress imaging to cardiac catheterization (cath) with revascularization + optimal medical therapy (OMT) (INV strategy) vs. and would be handled as a protocol amendment at participating sites. CKD patients are 5-10 times more likely to die than to reach ESRD . enrolment and all study procedures (except CCTA) as the main trial.• • • • • • Background CVD is the leading cause of death among patients with CKD. © 2012 Medtronic.

Not for distribution in the USA or Japan. For distribution only in markets where the Symplicity™ renal denervation system is approved. Special measures to be recommended to reduce risk. © 2012 Medtronic. UC201205567EE ISCHEMIA Chronic Kidney Disease Companion Trial cont’ . All rights reserved. Inc. Benefits • Limited observational studies of revascularization vs. Trademarks may be registered and are the property of their respective owners.Risks • Increased risk of contrast induced nephropathy in subjects undergoing cath (dependent on volume of contrast used mainly applicable to 25% of patients who undergo cath + PCI). medical therapy in this population suggest a significant survival benefit from revascularization. yet data show these patients often do not undergo cath and revascularization.