Download Sirolimus Nanocrystal Balloon- Based Delivery for Coronary DES

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