Sirolimus Nanocrystal Balloon Based Delivery for Coronary DES ISR

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1 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.

2 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.

3 ISR Mechanism

4 ISR Classification

5 LIMITATIONS IN PCI BALLOON ANGIOPLASTY INTRACORONARY STENTING DRUG ELUTING STENTS Elastic recoil Restenosis caused by cellular proliferation Stent thrombosis Increased neointimal hyperplasia leading to in stent restenosis. Late stent thrombosis Dependency on prolonged dual antiplatelet therapy Restenosis Drug eluting balloons (DEB) have emerged as a potential alternative to treat restenosis!

6 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

7 AREAS OF TREATMENT WITH DCB IN STENT RESTENOSIS SMALL VESSEL DISEASE BIFURCATION LESIONS DIFFICULT TO TREAT AREAS

8 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.

9 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.

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11 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

12 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

13 MAGIC TOUCH DRUG LOADING & RELEASE KINETICS

14 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 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) 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)

15 MAGIC TOUCH PK & CV PATH Inst.

16 Magic Touch DEB DES ISR DEVICE STUDY MAGIC TOUCH DEB (Sirolimus Balloon) 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

17 Magic Touch DEB Clinical Evaluation PARAMETERS VALUE (N=34) SEX MALE 28 18% Male Female FEMALE 6 82% 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 40% Baseline values Diabetes Mellitus 17% 20% 15% 8% Hypertension Family History Previous MI/CAD Previos PTCA/Stenting

18 Magic Touch DEB Clinical Evaluation PARAMETERS VALUE (N=34) Anginal Status ANGINAL STATUS STABLE 9 UNSTABLE 4 TOTAL SUBJECTS ENROLLED : N=34 (TOTAL IMPLANTS = 47) REAL WORLD REGISTRY DEVICE SUCCESS 100% (47/47) PROCEDURAL SUCCESS 100% (47/47) 31% Stable 69% Unstable

19 Magic Touch DEB Clinical Evaluation Vessels Treated TREATED VESSELS NO OF CASES (N=34), (LESIONS TREATED=36) GRAFT DIA 1 1 LAD 15 LCX 05 OM 2 RCA 12 OM 2 RCA 12 DIA 1 GRAFT 1 LCX 5 LAD

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

21 Magic Touch DEB Clinical Evaluation FOLLOW UP 1 MONTH 3 MONTH 6 MONTH (Clinical) 6 MONTH (Angio) NO OF PATIENTS No of patients 23 6 TOTAL 1M 3M 6M CIL EV 6M CAG EV TOTAL 1M 3M 6M CIL EV 6M CAG EV

22 Magic Touch DEB Clinical Evaluation FOLLOW UP 1 MONTH 3 MONTH 6 MONTH (Clinical) 6 MONTH (Angio) NO OF PATIENTS Adverse Events incl. MACE DEATH Cardiac Death Non Cardiac Death TLR TVR Non TVR

23 Magic Touch DEB Case 1 (Pre Procedure)

24 Magic Touch DEB Case 1(Procedure)

25 Magic Touch DEB Case 1 (Post Procedure)

26 Magic Touch DEB Case 2 With Follow up (Pre Procedure)

27 Magic Touch DEB Case 2 With Follow up (Procedure)

28 Magic Touch DEB Case 2 With Follow up (Post Procedure)

29 Magic Touch DEB Case 2 With Follow up (Follow up)

30 Conclusion