Transcript YUKON Choice PC

YUKON Choice ®PC
Sirolimus Eluting Coronary Stent System
with a Biodegradable Polymer
Technology Highlights
YUKON Choice PC is manufactured by Translumina Therapeutics in their manufacturing
Facility at Pharma City Dehradun. Its a collaboration between Advance Therapeutics and
Translumina GmbH, Germany.
• This is the first project where a proven
technology of a drug Eluting Stent is sourced
from Europe and is manufactured in India
using international standards .
• The technology is proven in large trials in
Europe but shall be sourced from India for
world.
• For the first time, High end machines and
layout are created as per the specifications of
European guidelines.
Translumina GmbH-Germany
• Founded in 1998 ,The promoters were in Senior Management positions in Guidant(Now abott)
and Boston Scientific.
• The company is based at Hechingen ,Germany with state of the art manufacturing facility.
• Translumina was the first company to launch a Drug Eluting Stent without a polymer,YUKON
Choice, using a innovative technology of in-cath lab coating in 2003 .
• Translumina is marketing its products in India for the last 6 years.All the raw materials for Indian
manufacturing shall be provided by Translumina GmbH
•
YUKON Choice PC is a combination of :
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Sirolimus
Microporous Stent surface
Biodegradable Polymer Resomer R202S
Shellac Resin
• YUKON Choice PC is a third generation
Sirolimus eluting Stent System that combines the
synergistic effect of surface modification and
biodegradable polymer to create optimum
release.
• YUKON Choice PC’s Stent surface is coated
abluminally with no drug or polymer on the
luminal side of the Stent for enhanced safety.
YUKON Choice PC - A generation ahead
less polymeric load compared to other DES
• YUKON Choice PC® has microporous surface which enables minimum load of
a biodegradable Polymer for optimizing the release kinetics
• Micro-pores which act like reservoirs for delivering the drug to the targeted
sites use Van-der-Waals forces to control the release- kinetics of the drug
YUKON Choice PC - Safety Features
• Better Endothelialization-No coating on the Luminal side of the Stent
• Biodegradable Polymer-Degrades in 90 days
• Less Polymeric Load-1/4th of the polymeric load compared to other DES
Release Kinetics
Drug and Polymer are co-released in 30-45 days
YUKON Choice PC - Efficacy Vs. Xience & Cypher
ISAR-TEST 4 is the first prospective randomized trial which compares 3 DES i.e.
YUKON Choice PC, Xience and Cypher for their efficacy & safety
YUKON Choice PC
ISAR-TEST 4 is the only trial with planned angiographic follow up at 2
years in more than 70% patients
ISAR-TEST 4 - Results
YUKON Choice PC proves non-inferior to Xience and Cypher at 3 years
follow up published in JACC Sept. 2011
ISAR-TEST 4 - Results
YUKON Choice PC proves non-inferior to Xience and Cypher at 3
years follow up published in JACC Sept. 2011
ISAR-TEST 4 - Results
YUKON Choice PC shows similar TLR’s compared to Xience and Cypher
at 2 years follow up
ISAR-TEST 4 - AMI Sub-group
YUKON Choice PC has least polymeric load of a biodegradable polymer and thus
is hypothesized to how better results than Xience and Cypher
ISAR-TEST 4 - AMI Sub-group
YUKON Choice PC shows better results than Xience and Cypher in AMI patients
Yukon Choice PC 4 years follow-up data compared
to first generation DES
ISAR-TEST 4 - 3 years follow-up
ISAR-TEST 4 is the only comparative trial of 3 DES, YUKON Choice PC Xience and
Cypher, with 3 years follow-up
ISAR-TEST 4 - Study Flow
ISAR-TEST 4 - Results
YUKON Choice PC is the First DES which has shown statistical significant
reduction of Stent Thrombosis by 50% compared to first generation DES.
ISAR-TEST 4 - Results
YUKON Choice PC shows 78% reduction in Stent Thrombosis compared
to first generation DES.
YUKON Choice PC - Excellent Safety Profile
• YUKON Choice PC is the First DES which has shown statistical significant
reduction in Stent thrombosis compared to first generation DES.
• YUKON Choice PC shows 78% reduction in Stent Thrombosis compared to
first generation DES.
• The unique combination of microporous Stent surface and less
biodegradable polymeric load ensures that it becomes a BMS after the
drug delivery.
• The presence of drug only on the abluminal side ensures healthy
endothelialization.
• Limited anti-platelet regimen may be required after implantation.