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Sirolimus Nanocrystal Balloon‐ Based Delivery for Coronary DES‐ ISR DR. SAMEER I DANI Director, Department of Cardiology, Apollo Hospital & Life Care Institute (LIMSAR), Ahmedabad, India. IN‐STENT RESTENOSIS (ISR) • Restenosis occurs when the treated vessel becomes blocked again which occurs within 6 months after the initial procedure. • In about 25% of patients, the growth of scar tissue underneath the lining of the artery may be so thick that it can obstruct the blood flow and produce an important blockage. ISR – Mechanism ISR – Classification LIMITATIONS IN PCI BALLOON ANGIOPLASTY • Elastic recoil • Restenosis caused by cellular proliferation INTRACORONARY STENTING • Stent thrombosis • Increased neointimal hyperplasia leading to in‐stent restenosis. DRUG ELUTING STENTS • Late stent thrombosis • Dependency on prolonged dual antiplatelet therapy • Restenosis Drug‐eluting balloons (DEB) have emerged as a potential alternative to treat restenosis! INTRODUCTION TO DCB • DEB technology demonstrated safety and efficacy in preclinical and in randomized clinical trials for patients with in‐stent restenosis Good highly deliverable balloon catheter with low profile Biocompatible effective drug carrier Effective drug which addresses and control NI growth AREAS OF TREATMENT WITH DCB IN‐STENT RESTENOSIS SMALL VESSEL DISEASE BIFURCATION LESIONS DIFFICULT TO TREAT AREAS DCB – Mechanism of action for ISR • In recent years, drug‐eluting balloons (DEB) have emerged as a potential alternative to combat restenosis. • Drug‐Eluting Balloon are conventional balloon catheter coated with anti‐proliferative drug for non stent‐based local drug delivery. • After balloon expansion the drug is released into the vessel wall in a targeted manner aiming to achieve high local concentration in the vessel wall & minimal systemic release reducing the smooth muscle cell proliferation thus reduces restenosis and recurrence of symptoms. MAGIC TOUCH DCB is based on Nanolute™ technology FIRST Drug Coated Balloon to successfully deliver SIROLIMUS drug Nano carrier based drug delivery Application of nano carrier drug delivery concept using a highly bio‐compatible excipient based carrier. MAGIC TOUCH ‐ NANOTECHNOLOGY • Nano Carriers created using a hybrid homogenization and sonication process • Drug encapsulated in Phospholipid excipient based carrier with particle size ranging from 50 to 300 nm • Innovative Spray coating method of nano carriers deposition on balloon • Carrier has Hydrophilic Head & Lipophilic tails which are used to encapsulate nano sized drug particle creating a nano carrier • Ensures higher tissue transfer • Promotes healing in Arterial tissue Nano carrier based drug delivery MAGIC TOUCH DRUG ELUTING BALLOON • Readily absorbed in vessel wall and releases encapsulated drug on variation in pH and break‐up of encapsulation • Enhances bio‐compatibility of drug delivery with pro‐healing effect of excipient Magic Touch Drug Loading: 180 µgm on 3.0 x 15 mm MAGIC TOUCH‐DRUG LOADING & RELEASE KINETICS MAGIC TOUCH – PRE CLINICAL EVALUATIONS STUDY DETAILS N= EVALUATION PK & Histologic Evaluation 17 1, 8 & 14 Day Pharmacokinetic & 28 Day Histopathology 28 OCT Evaluation 8 28 Day Oct Evaluation For Neo Intimal Inhibition Dose Finding Study 17 28 Day Evaluation Of Drug To Excipient Dose Study With Control By PK And Histopathology DTF Label Study 4 1 & 24 Hr, 3 And 7 Days DTF Label Study For Drug Distribution & Penetration Efficacy Study (Compared with DES) 17 28 Day Evaluation Of DCB With Commercial Des As Control With Histopathology And OCT Analysis PRE CLINICAL EVALUATION – ANIMAL MODEL ( NZ WHITE RABBIT AND BRAZILIAN PORCINE) MAGIC TOUCH – PK & Histology @ CV PATH Inst. Magic Touch DEB – DES ISR DEVICE MAGIC TOUCH DEB (Sirolimus Balloon) STUDY Single center experience with Sirolimus DCB in treatment of DES – ISR Patients Enrolment Criteria Evaluation of DES‐ISR Patients treated with Sirolimus based DEB in real world scenario ‐ Patients recruited from routine clinical practice Number of Subjects 34 Magic Touch DEB – Clinical Evaluation PARAMETERS VALUE (N=34) Male Female 18% SEX MALE 28 FEMALE 6 PARAMETERS VALUE (N=34) AGE (Average) 57.32±7.46 DIABETES MELLITUS 17 HYPERTENSION 13 FAMILY HISTORY 7 PREVIOUS MI/CAD 15 PREVIOUS PTCA/STENTING 34 82% Baseline values Diabetes Mellitus 20% Hypertension 40% 15% 17% Family History Previous MI/CAD 8% Previos PTCA/Stenting Magic Touch DEB – Clinical Evaluation PARAMETERS VALUE (N=34) Anginal Status ANGINAL STATUS STABLE 9 UNSTABLE 4 31% 69% TOTAL SUBJECTS ENROLLED : N=34 (TOTAL IMPLANTS = 47) REAL WORLD REGISTRY DEVICE SUCCESS 100% (47/47) PROCEDURAL SUCCESS 100% (47/47) Stable Unstable Magic Touch DEB – Clinical Evaluation Vessels Treated TREATED VESSELS NO OF CASES (N=34), (LESIONS TREATED=36) LAD 15 LCX 05 RCA 12 OM 2 DIA 1 GRAFT 1 GRAFT 1 DIA 1 OM 2 RCA 12 LCX 5 LAD 15 0 5 10 15 20 Magic Touch DEB – Clinical Evaluation TOTAL NUMBER (N=34) VALUE SMALL VESSEL < 2.5 MM 17 LONG LESION > 20 MM 33 BALLOON USAGE 47 BALLOON LENGTH, MM 22.44±6.58 BALLOON DIAMETER, MM 2.76±0.35 AVERAGE BALLOON PER PATIENT 1.38 DEVICE COMPLICATION 0 STENT IMPLANTATION AFTER TREATMENT 2 Magic Touch DEB – Clinical Evaluation FOLLOW UP 1 MONTH NO OF PATIENTS 40 35 30 3 MONTH 28 23 06 No of patients 34 30 30 25 20 6 MONTH (Clinical) 6 MONTH (Angio) 28 TOTAL 23 1M 3M 15 10 6M CIL EV 6 5 0 TOTAL 1M 3M 6M CIL EV 6M CAG EV 6M CAG EV Magic Touch DEB – Clinical Evaluation FOLLOW UP 1 MONTH 3 MONTH 6 MONTH (Clinical) 6 MONTH (Angio) NO OF PATIENTS 30 28 23 06 Adverse Events incl. MACE 0 0 0 0 DEATH 0 0 0 0 Cardiac Death 0 0 0 0 Non Cardiac Death 0 0 0 0 TLR 0 0 0 0 TVR 0 0 0 0 Non‐TVR 0 0 0 0 Magic Touch DEB –Case 1 (Pre‐Procedure) Magic Touch DEB –Case 1(Procedure) Magic Touch DEB –Case 1 (Post‐Procedure) Magic Touch DEB – Case 2 With Follow up (Pre‐Procedure) Magic Touch DEB – Case 2 With Follow up (Procedure) Magic Touch DEB – Case 2 With Follow up (Post – Procedure) Magic Touch DEB – Case 2 With Follow up (Follow up) Conclusion