IN.PACT DEB                                      IN.PACT DEB Technology                      TECHNOLOGYIN.PACT DEBTechnolo...
IN.PACT DEB                                                 IN.PACT DEB Technology                           TECHNOLOGY   ...
IN.PACT DEB Technology                                                                                                    ...
IN.PACT DEB Technology                                                                                                    ...
IN.PACT DEB Technology                                                                                                    ...
IN.PACT DEB                                                     IN.PACT DEB Technology                             TECHNOL...
IN.PACT DEB Technology                                                                                                    ...
IN.PACT DEB                                              IN.PACT DEB Technology                      TECHNOLOGYIN.PACT DEB...
IN.PACT DEB Technology                                                                                                    ...
IN.PACT DEB Technology                                                                                                    ...
IN.PACT DEB Technology                                                                                                    ...
IN.PACT DEB Technology                                                                                                    ...
IN.PACT DEB Technology                                                                                                    ...
IN.PACT DEB Technology                                                                                                    ...
IN.PACT DEB                                               IN.PACT DEB Technology                       TECHNOLOGYIN.PACT D...
IN.PACT DEB Technology                                                                                                    ...
IN.PACT DEB Technology                                                                                                    ...
Medtronic In.Pact Clinical Evidence
Medtronic In.Pact Clinical Evidence
Medtronic In.Pact Clinical Evidence
Medtronic In.Pact Clinical Evidence
Medtronic In.Pact Clinical Evidence
Medtronic In.Pact Clinical Evidence
Medtronic In.Pact Clinical Evidence
Medtronic In.Pact Clinical Evidence
Medtronic In.Pact Clinical Evidence
Medtronic In.Pact Clinical Evidence
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Medtronic In.Pact Clinical Evidence

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Medtronic In.Pact Clinical Evidence

  1. 1. IN.PACT DEB IN.PACT DEB Technology TECHNOLOGYIN.PACT DEBTechnology and CLINICAL TRIALClinical Evidence OVERVIEW Clinical Trial Overview SFA RESULTS SFA Results BTK RESULTS BtK Results Order information & Abbreviations ORDER INFORMATION & ABBREVATIONS
  2. 2. IN.PACT DEB IN.PACT DEB Technology TECHNOLOGY 4 DEB ComponentsIN.PACT DEB FreePac Coating Technology How to use a DEBTechnology and CLINICAL TRIALClinical Evidence OVERVIEW Clinical Trial Overview SFA RESULTS SFA Results BTK RESULTS BtK Results Order information & Abbreviations ORDER INFORMATION & ABBREVATIONS
  3. 3. IN.PACT DEB Technology TECHNOLOGY IN.PACT PACLITAXELELUTING BALLOONS Clinical Trial Overview IN.PAC T DEB TECHNOLOGY 4 DEB components interweaving towards performance... MEDTRONIC INVATEC 1. PLATFORM proven PTA full balloon line SFA Results PACLITAXEL 2. DRUG hydrophobic, lipophilic, proven antiproliferative drug UREA 3. EXCIPIENT hydrophilic, non toxic MEDTRONIC INVATEC BtK Results©2011 Medtronic, Inc. All Rights Reserved. Printed in EU. Not for distribution in the USA. 0170631, 01/12 4. COATING TECH uniformity + stability + release controlled and scaleable IN.PACT Admiral IN.PACT Pacific IN.PACT Amphirion Paclitaxel-Eluting Paclitaxel-Eluting Paclitaxel-Eluting PTA Balloon Catheter 0.035" PTA Balloon Catheter 0.018" PTA Balloon Catheter 0.014” Order information & Abbreviations
  4. 4. IN.PACT DEB Technology TECHNOLOGY IN.PACT PACLITAXELELUTING BALLOONS IN.PACT DEB TECHNOLOGY Clinical Trial Overview IN.PACT™ DEB WITH FREEPAC™ COATING TECHNOLOGY IN.PACT™ Medtronic Invatec DEB balloon line FREEPAC™ Proprietary hydrophilic coating formulation – Urea separates Paclitaxel molecules – Increased drug solubility and optimal diffusion into vessel wall – Urea facilitates Paclitaxel absorption into the vessel wall SFA Results PACLITAXEL - proven antiproliferative UREA - natural and hydrophilic excipient©2011 Medtronic, Inc. All Rights Reserved. Printed in EU. Not for distribution in the USA. 0170631, 01/12 BtK Results IN.PACT Paclitaxel elution timeline 10 SECONDS 15 SECONDS 60 SECONDS Order information & Abbreviations WRAPPED BALLOON FOLDS UNWRAPPING BALLOON INFLATED AND ELUTING ELUTION DRUG UPTAKE The IN.PACT DEB is The balloon unwraps to Urea molecules facilitate carriage Drug elution takes place COMPLETED delivered to the target site expose the FreePac coating of paclitaxel molecules across the within 30 - 60 seconds vessel wall www.medtronic.com Global Headquarters www.invatec.com Hungerbüelstrasse 12 8500 Frauenfeld – Switzerland
  5. 5. IN.PACT DEB Technology TECHNOLOGY IN.PACT PACLITAXELELUTING BALLOONS IN.PACT DEB TECHNOLOGY Clinical Trial Overview HOW TO USE DRUG ELUTING BALLOONS FOLDED BALLOON HANDLE WITH CARE • DEB surface can be touched and handled gently Handle with care • Do not rub the coated balloon • Do not use any protective / insertion sheath to advance the DEB trough the introducer sheath and/or hemostatic valve 1. Lesion PRE-DILATATION RECOMMENDED IN CERTAIN CASES SFA Results 2. Pre-dilatation • For pre-dilatation in case of total occlusions or sub-occlusive lesions use a standard balloon 3. DEB (approx. 0.5 mm smaller than RVD) • Choose a DEB with a nominal size equal to reference diameter DRUG RELEASE WITHIN 30 - 60 SECONDS • Longer inflation times are possible at discre t ion of operator - to pursue optimal Duration time 30 - 60 sec. mechanical dilatation - but do not lead to further drug release©2011 Medtronic, Inc. All Rights Reserved. Printed in EU. Not for distribution in the USA. 0170631, 01/12 BtK Results ONE DRUG-ELUTING BALLOON Lesion 1, DEB 1 Lesion 2, DEB 2 FOR EACH LESION • For single use only, drug is released upon the first inflation • In longer lesions DEB overlapping is indicated Order information & Abbreviations overlap overlap IF A STENT IS PRESENT AN OVERLAP WITH DEB IS RECOMMENDED www.medtronic.com Global Headquarters www.invatec.com Hungerbüelstrasse 12 8500 Frauenfeld – Switzerland
  6. 6. IN.PACT DEB IN.PACT DEB Technology TECHNOLOGYIN.PACT DEBTechnology and CLINICAL TRIALClinical Evidence OVERVIEW Clinical Trial Overview IN.PACT Clinical Trial Program SFA RESULTS SFA Results BTK RESULTS BtK Results Order information & Abbreviations ORDER INFORMATION & ABBREVATIONS
  7. 7. IN.PACT DEB Technology OVERVIEW IN.PAC T CLINICAL TRIAL PROGRAM 16 Clinical Trials / 10 RCT / 113 Clinical Sites / 2.020 patients Clinical Trial Overview Primary Indication Design # Sites Arms Endpoint Pl(s) #Pts SFA IN.PACT SFA I SFA de-novo RCT 10 DEB vs PTA + 12m Prim. G. Tepe 150 prov Stent Patency IN.PACT SFA II SFA de-novo RCT 50 DEB vs PTA + 12m Prim. P. Schneider, 280 prov Stent Patency J. Laird DEB SFA IT Registry* SFA de-novo Registry 6 DEB + prov 6m Patency A. Micari 105 Stent PACIFIER* SFA de-novo RCT 3 DEB vs PTA + 6m LLL M. Werk 91 prov Stent ISAR-STATH* SFA de-novo RCT 2 DEB + Stent vs 6m %DS I. Ott, 150 Stent vs Ather. M. Fusaro IN.PACT CALCIUM* SFA de-novo Registry 1 Atherectomy 12m RR (DUS) A. Cioppa 20 SFA Results Ca++ + DEB SFA-ISR PHOTOPAC* SFA ISR RCT 3 Laser + DEB vs 12m %DS T. Zeller 50 DEB alone FAIR* SFA ISR RCT 3 DEB vs PTA 6m DUS re- H. Kranken- 118 restenosis berg ISAR PEBIS* SFA ISR RCT 1 DEB vs PTA 6m %DS I. Ott, 70 M. Fusaro FRENCH SFA Registry* SFA ISR Registry 13 DEB 12m TLR Y. Gouëffic 100 SFA & BTK DEBELLUM* SFA BTK RCT 1 DEB vs PTA 6m LLL F. Fanelli 50©2011 Medtronic, Inc. All Rights Reserved. Printed in EU. Not for distribution in the USA. 0170632, 01/12 BtK Results BTK DEB BTK IT Registry* BTK de-novo Registry 6 DEB + prov 6m RR (Angio) G. Biamino 100 Stent IN.PACT BTK Abano* BTK de-novo Registry 1 DEB + prov 6m RR (Angio) M. Manzi 122 Stent IN.PACT BTK DEB BTK de-novo Registry 1 DEB + prov 3m RR (Angio) D. Scheinert 107 Leipzig Registry* Stent IN.PACT DEEP BTK / CLI RCT 11 DEB vs PTA + 12m LLL + TLR I. Baumgart- 357 Order information & Abbreviations de-novo prov Stent + 6m Events ner, T. Zeller, D. Scheinert DEBATE* BTK/CLI/ RCT 1 DEB vs PTA + 12m Angio RR F. Liistro 150 Diabetics prov Stent * Physician sponsored STATUS DATE: 01/2012
  8. 8. IN.PACT DEB IN.PACT DEB Technology TECHNOLOGYIN.PACT DEBTechnology and CLINICAL TRIALClinical Evidence OVERVIEW Clinical Trial Overview SFA RESULTS SFA Results Italian SFA Registry SFA Trial PACIFIER SFA Trial DEBELLUM BTK RESULTS BtK Results Order information & Abbreviations ORDER INFORMATION & ABBREVATIONS
  9. 9. IN.PACT DEB Technology SFA CAS, Supraortic DE-NOVOIN.PACT AdmiralPACLITAXELELUTING PTA BALLOON CATHETER 0.035"DRUG-ELUTING BALLOONS FOR LOWER LIMB ARTERIAL DISEASEDEB SFA Clinical Trial OverviewITALIAN REGISTRY*IN.PACT drug-eluting balloon demonstrateshigh primary patency with low stent rateData presented at PCR 2011 by Dr. Micari REGISTRY PURPOSE To assess the benefit of DEB usage within standard practice for the treatment of femoro-popliteal arterial disease in patients with claudication and rest pain SFA Results PRIMARY ENDPOINT The primary endpoint was primary patency at 12 months STUDY METHODS - Investigator sponsored multi-center observational registry - Predilatation with conventional undersized PTA balloon, DEB dilatation for 180 sec - Provisional stenting in case of flow limiting dissections and persistent residual stenosis > 50% BtK Results PATIENT DEMOGRAPHICS (105 PATIENTS, AGE 68 ± 9) Hypertension 90 (85.7%) DEB SFA Hyperlipidaemia ITALIAN REGISTRY 78 (74.3%) Diabetes 51 (48.6%) * Micari et al., EuroIntervention Volume 7, Insul. dependant 23 (45.1%) Supplement K, May 2011, A new paclitaxel- eluting balloon for angioplasty of femoro- Order information & Abbreviations Renal insufficiency 2 (1.9%) popliteal obstructions: acute and midterm results Smoking 66 (62,8%) Coronary Artery Dis. 45 (42.9%) Carotid Artery Dis. 15 (14.3%) 10 20 30 40 50 60 70 80 90 100 Average Lesion Length: 76mm. Total Occlusions: 29.8%. ABI 0.56 ± 0.15 Rutherford Class II 26,7%, Rutherford Class III 64,8%, Rutherford Class IV 7.6% STATUS DATE: 02/2012
  10. 10. IN.PACT DEB Technology SFA DE-NOVO IN.PACT Admiral PACLITAXELELUTING PTA BALLOON CATHETER 0.035” DEB SFA ITALIAN REGISTRY IN.PACT drug-eluting balloon Clinical Trial Overview demonstrates high primary PTA Balloon Catheter patency with low stent rate ACUTE OUTCOME Pre-dilatation · · · · · · · · · · · · · · · · · · · · · · 113 (99.1%) DEB inflation time · · · · · · · · · · · · · · · · · · · · · · 181 ± 20.4 sec No DEB p/lesion · · · · · · · · · · · · · · · · · · · · · · 135/114 = 1.18 Device Success · · · · · · · · · · · · · · · · · · · · · · 135 (100%) Tech. Success · · · · · · · · · · · · · · · · · · · · · · 121 (89.6%) SFA Results Stenting · · · · · · · · · · · · · · · · · · · · · · 14 (12.3%) 12 MONTHS RESULTS – Primary Patency 83.7% – TLR rate 8.7% 100% 90% – ABI, Quality of Live, 80% Walking capacity, 70% 12M Survival from TLR, Occlusion, >50% Restenosis 60% Primary Patency 83.7% Rutherford class 50% improvements 40% 30% PSVR <2.5 20%©2012 Medtronic, Inc. All Rights Reserved. Printed in EU. Not for distribution in the USA. 0170633, 02/12 BtK Results 10% days after procedure 0 180 360 REGISTRY CONCLUSION & DISCUSSION – High primary patency rate and low TLR rate despite conservative usage of stents – Clinical benefit is consistently shown across multiple endpoints Order information & Abbreviations Patency rates are in line with previously reported results of Drug Eluting Balloons (Thunder, Fempac)** ** Tepe et al., N Engl J Med 2008; 358:2406-2407 / Werk et al., Circulation. 2008; 118: 1358-1365 www.medtronic.com Global Headquarters www.invatec.com Hungerbüelstrasse 12 8500 Frauenfeld – Switzerland STATUS DATE: 02/2012
  11. 11. IN.PACT DEB Technology SFA DE-NOVOIN.PACT PacificPACLITAXELELUTING PTA BALLOON CATHETER 0.018"DRUG-ELUTING BALLOONS FOR LOWER LIMB ARTERIAL DISEASESFA TRIAL  PACIFIER Clinical Trial OverviewIN.PACT drug eluting balloon superior to PTA withregards to 6 months Late Lumen LossData presented at LINC 2012 by Dr. Werk STUDY PURPOSE To demonstrate efficacy of the paclitaxel eluting balloon to inhibit restenosis of femoropopliteal stenosis and occlusions vs. standard PTA SFA Systems Stent Results PRIMARY AND SECONDARY ENDPOINTS - The primary endpoint was Late Lumen Loss (LLL) at 6 months - Secondary endpoints: 6-m binary restenosis rate, 6-m TLR, 6-m RC change, 6-m event free survival STUDY METHODS - Investigator sponsored multi-center randomized (1:1) trial - Independent, blinded Angiographic Corelab - Provisional stenting in case of flow limiting dissection or persistent residual stenosis BtK Results PATIENT DEMOGRAPHICS AND LESION CHARACTERISTICS DEB Control THE PACIFIER TRIAL No. of Patients n 44 47 * A Randomized Multicenter Trial Evaluating Mean Age y ± SD 71 ± 7 71 ± 9 Prevention of Restenosis with Paclitaxel- Coated PTA Balloon Catheters in Stenosis or Diabetes n (%) 19 (43%) 13 (28%) Occlusion of Femoropopliteal Arteries Hypertension n (%) 29 (66%) 31 (66%) M. Werk, T. Albrecht, D.-R. Meyer, H. Stiepani, Hypercholesterolemia n (%) 22 (50%) 22 (47%) B. Schnorr, U. Dietz, E. Lopez Hänninen ABI mean ± SD 0.73 ± 0.30 0.65 ± 0.26 Order information & Abbreviations Departments of Radiology of the Martin- 95% of patients were in Rutherford Luther-Hospital, Hubertus-Hospital, Vivantes Klinikum Neukölln, Berlin, Germany classes 2 or 3 at baseline. Avg lesion length cm ± SD 7.0 ± 5.3 6.6 ± 5.5 presented at LINC 2012 Ref. Vessel Diameter mm 4.92 4.90 % Diameter Stenosis (%) 73% 80% Total Occlusions n (%) 10 (23%) 18 (38%) 68% (DEB arm) were de-novo lesions, but also restenotic and ISR was included in the protocol. STATUS DATE: 02/2012
  12. 12. IN.PACT DEB Technology SFA DE-NOVO IN.PACT Pacific PACLITAXELELUTING PTA BALLOON CATHETER 0.018” SFA TRIAL  PACIFIER IN.PACT drug eluting balloon superior Clinical Trial Overview to PTA with regards to 6 months Late Lumen Loss ACUTE OUTCOME DEB Control P value Pre-Dilatation n (%) 6 (13.6%) 3 (6.4%) 0.30 Balloon inflation time mean ± SD 76 ± 33 sec 76 ± 25 sec 0.89 Dissections n (%) 18 (41%) 25 (53%) 0.48 Provisional Stent Rate n (%) 9 (21%) 16 (34%) 0.17 Residual Stenosis mean±SD 12±12% 11±12% 0.5 6 MONTHS RESULTS (ANGIOGRAPHIC AND CLINICAL) SFA Results DEB Control P value % Diameter Stenosis % 29.7% 39.4% 0.05 Min. Lumen Diameter mm 3.61 2.94 0.0014 Binary Restenosis n/N (%) 3/35 (8.6%) 11/34 (32.4%) 0.01 Late Lumen Loss mm -0.01 0.65 0.0014 6M MAJOR p=0.04 ADVERSE EVENTS 30% – p=0.12 26.2% 25% – 21.4% DEB 20% – Control 15% –©2012 Medtronic, Inc. All Rights Reserved. Printed in EU. Not for distribution in the USA. 0170634, 02/12 10% – BtK Results 7.1% 7.1% Go Deep 4.8% 5% – 0% – 0.0% 0.0% 0.0% TLR Amputation Death Composite CONCLUSION IN.PACT PACIFIC™ confirms to effectively reduce neointima hyperplasia in SFA with a significant decrease in LLL at 6 months vs standard PTA Clinical Events (Secondary Endpoints) trend / are in favor of DEB Order information & Abbreviations No coating related adverse events noted www.medtronic.com Global Headquarters www.invatec.com Hungerbüelstrasse 12 8500 Frauenfeld – Switzerland STATUS DATE: 02/2012
  13. 13. IN.PACT DEB Technology SFA/BTKIN.PACT AdmiralPACLITAXELELUTING PTA BALLOON CATHETER 0.035"IN.PACT AmphirionPACLITAXELELUTING PTA BALLOON CATHETER 0.014"DRUG-ELUTING BALLOONS FOR LOWER LIMB ARTERIAL DISEASEDEBELLUM: Drug Eluting Balloon Clinical Trial OverviewEvaluation for Lower Limb mUltilevel treatMent*IN.PACT drug eluting balloon superior to PTA with regardsto 6 months Late Lumen LossData presented at MEET 2011 by Dr. F. Fanelli STUDY PURPOSE To assess the effect of DEB for multilevel lower limb revascularization compared to PTA PRIMARY AND SECONDARY ENDPOINTS SFA Results - The primary endpoint was Late Lumen Loss (LLL) at 6 months (US evaluation) - Secondary endpoints: Target Lesion Revascularization, Thrombosis and Amputation STUDY METHODS – Investigator sponsored single-center randomized (1:1) trial – Provisional Stenting in case of flow limiting dissection or persistent residual stenosis – Study devices: IN.PACT Amphirion (BtK) and IN.PACT Admiral (SFA) STUDY DESIGN N= 50 PTS. PRIMARY ENDPOINT: LATE LUMEN LOSS AT 6 MONTHS BtK Results DEB N= 25 pts | 57 lesions N= 25 PTS | 65 LESIONS Uncoated balloons Native Stenosis Stenting Native Stenosis Stenting (26 lesions) (31 lesions) (30 lesions) (35 lesions) PATIENT DEMOGRAPHICS AND LESION CHARACTERISTICS Patient Lesion DEBELLUM Drug-Eluting Abbreviations Demographics Characteristics * Dr. Fabrizio Fanelli Patients n 50 Overall Lesions 122 Vascular and Interventional Radiology Unit Department of Radiological Sciences Order information &Balloons Age y 67 ± 21 Femoro-Popliteal Lesions 92 (76%) “Sapienza” - University of Rome Diabetes 22 (45%) BtK Lesions 30 (24%) presented at MEET 2011 High Cholesterol 29 (59%) Mean Lesion Length (cm) 7.5 ± 3.5 Hypertension 34 (68%) % Stenosis 85 ± 6.4 ABI 0.53 ± 0.18 Diameter Total Occlusion 26 (22%) Fontaine Stage 2b 31 (62%) Fontaine Stage 3 14 (28%) Fontaine Stage 4 5 (10%) STATUS DATE: 02/2012
  14. 14. IN.PACT DEB Technology SFA/BTK IN.PACT Admiral PACLITAXELELUTING PTA BALLOON CATHETER 0.035" IN.PACT Amphirion PACLITAXELELUTING PTA BALLOON CATHETER 0.014" DRUG-ELUTING BALLOONS FOR LOWER LIMB ARTERIAL DISEASE DEBELLUM: Drug Eluting Balloon IN.PACT drug eluting balloon Clinical Trial Overview superior to PTA with regards to 6 months Late Lumen Loss Evaluation for Lower Limb mUltilevel treatMent 6 MONTHS RESULTS (ANGIOGRAPHIC AND CLINICAL) Overall analysis: 0.5±1.4mm (DEB) vs 1.6±1.7mm (PTA). P<0.01 Native stenosis analysis: 0.5mm (DEB) vs 1.5mm (PTA. P<0.01 Stent analysis: 0.51mm (DEB) vs 1.7mm (PTA). P<0.01 6 MONTHS SUBANALYSIS 2.0 mm – 1.7 1.6 1.5 1.5 mm – SFA Results DEB 1.0 mm – PTA 0.5 0.5 0.51 0.5 mm – 0 mm – Overall values Native Stenosis Stent Analysis Analysis SECONDARY ENDPOINTS TLR clinically and diagnostic 40% – 36 (USCD or DSA) driven 30% – DEB 25% – PTA 20% –©2012 Medtronic, Inc. All Rights Reserved. Printed in EU. Not for distribution in the USA. 0170635, 02/12 BtK Results 15% – 12 10% – 8 7 8 5% – 3 0% – TLR Thrombosis Amputation CONCLUSION Order information & Abbreviations Drug eluting balloons are safe and effective for the inhibition of neointimal hyperplasia No significative different results between native stenosis and post-stents dilatation Six-months follow-up showed lower neointimal hyperplasia, lower TLR rates and better clinical outcomes in the DEB group compared with the non-coated balloon group.* * the study was not powered against secondary endpoints. www.medtronic.com Global Headquarters www.invatec.com Hungerbüelstrasse 12 8500 Frauenfeld – Switzerland STATUS DATE: 02/2012
  15. 15. IN.PACT DEB IN.PACT DEB Technology TECHNOLOGYIN.PACT DEBTechnology and CLINICAL TRIALClinical Evidence OVERVIEW Clinical Trial Overview SFA RESULTS SFA Results BTK RESULTS BtK Results BtK DEB Leipzig Registry DEBATE-BtK Order information & Abbreviations ORDER INFORMATION & ABBREVATIONS
  16. 16. IN.PACT DEB Technology BTK DE-NOVOIN.PACT AmphirionPACLITAXELELUTING PTA BALLOON CATHETER 0.014"BTK DEB LEIPZIG Clinical Trial OverviewREGISTRYIN.PACT drug eluting balloon reduces early restenosisand TLR Rate of long BtK lesions REGISTRY PURPOSE The purpose of this study was to investigate the efficacy of drug-eluting balloons (DEBs) in the treatment of long infrapopliteal lesions with regard to the short-term SFA Results restenosis rate and midterm clinical result. PRIMARY ENDPOINT The primary endpoint was the angiographic binary restenosis. STUDY METHODS Infrapopliteal angioplasty was performed with an IN.PACT AMPHIRION paclitaxel-eluting balloon clinical and angiographic follow-up was performed at 3 months to detect bina- ry restenosis, and further clinical assessment was performed over a 12-month period. Btk Results PATIENT DEMOGRAPHICS (104 Patients, Age 73.6 ± 6.7, Male 69 =66.3%) Arterial hypertension 95 (91.3%) BTK REGISTRY Diabetes mellitus 74 (71.1%) Smoking habit 32 (30.8%) * Schmidt et al. J Am Coll Cardiol.2011; 58: 1105- Hypercholesterolemia 1109 68 (65.4%) Order information & Abbreviations ** Schmidt et al. Catheterization and Cardiovas- Obesity 33 (31.7%) cular Interventions, 76: 1047–1054 Coronary artery disease 47 (45.9%) NYHA functional classes III and IV 23 (22.1%) A. Schmidt, MD Center of Vascular Medicine Angiolo-Renal insufficiency (GFR 60 ml/min/1.73 m2) 48 (46.2%) gy, Cardiology and Vascular Surgery Cerebrovascular disease 19 (18.3%) Park Hospital Leipzig, Germany 10 20 30 40 50 60 70 80 90 100 STATUS DATE: 01/2012
  17. 17. IN.PACT DEB Technology BTK DE-NOVO IN.PACT Amphirion PACLITAXELELUTING PTA BALLOON CATHETER 0.014” BTK DEB LEIPZIG REGISTRY IN.PACT drug eluting balloon reduces early Clinical Trial Overview restenosis and TLR Rate of long BtK lesions ANGIOGRAPHIC RESULTS Mean infrapopliteal lesion length was 17.6mm. Angiography at 3 months found 72.6% of all arteries free of significant restenosis. Rate of completely occluded arteries · · · · · · · · · · · · · · · · · · · · · · · · · 9.5% Binary restenosis rate at 3 months · · · · · · · · · · · · · · · · · · · · · · · · · 27.4% 3 MONTHS ANGIOGRAPHIC Distal popliteal 1 (9.1%) RESTENOSIS RATE BY VESSEL DISTRICT Anterior tibial artery 15 (31.3%) (104 PATIENTS, AGE 73.6 ± 6.7) Tibioperone al trunk 3 (16.7%) Posterior tibial artery 5 (31.3%) Peronal artery 3 (16.7%) Proximal segment of tibial arteries 5 (9.3%) Mid segment of tibial arteries 9 (20.0%) SFA Results Distal segment of tibial arteries 7 (18.9%) Arteries distal to the malleolus 5 (38.5%) 5 10 15 20 25 30 35 40 CLINICAL RESULTS Favourable clinical results and a limb salvage rate of 95.4% TLR at 12 months · · · · · · · · · · · · · · · · · · · · · · · · · 17.4% Clinical improvement · · · · · · · · · · · · · · · · · · · · · · · · · 95.6% Complete wound healing · · · · · · · · · · · · · · · · · · · · · · · · · 74.2% RUTHERFORD SHIFT (12.5 MONTHS) 70 baseline Numbers of limbs 70 (64.2%) 60 19 (17.45%) 19 (17.45%) mid-term FU 50 40 Btk Results©2012 Medtronic, Inc. All Rights Reserved. Printed in EU. Not for distribution in the USA. 0170636, 01/12 30 1 (0.9%) 20 10 0 Rutherford-Becker categories 0 1 2 3 4 5 6 REGISTRY CONCLUSION & DISCUSSION The early restenosis rate of long-segment infrapopliteal disease is significantly lower after treatment with DEBs compared with historical data using uncoated balloons. Order information & Abbreviations A historical control group** with similar patients showed 69% binary restenosis rate at 3 months, 56% restenosis of the whole segment and a TLR rate of 50% at 15 months. DEB resulted in better restenosis rate at 3 months, lower rate of totally occluded arte- ries and lower TLR rates. www.medtronic.com Global Headquarters www.invatec.com Hungerbüelstrasse 12 8500 Frauenfeld – Switzerland STATUS DATE: 01/2012

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