Sirolimus Eluting Coronary Stent System with a Biodegradable Polymer

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Presentation transcript:

Sirolimus Eluting Coronary Stent System with a Biodegradable Polymer 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 : - 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.

less polymeric load compared to other DES 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

Drug and Polymer are co-released in 30-45 days 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.