Comparative postmarketing studies (Phase IV) of Russian drug-eluting Coronary Stent CALYPSO versus analogues.

7 Nov 2015

Vietnam National Heart Association National Scientific Meeting in Ninh Bình city, Vietnam.

2007

2009

15 types of products for interventional cardiology

2012

ISO 9001:2008, ISO 13485:2012

$ 5 mil.

35 k local stents implantations are performed

60 clinics in 37 Russian regions

2400 implantations

98,7%

Occluder, cavafilter

Collaborative work of the company with the scientific community

Russian developer and producer of coronary stents

the foundation of the company in the Technopark of Novosibirsk Academgorodok. The company’s manufacturing site has the same location.

Bare metal stents “Sinus” and balloon catheters “Colubris” were registered by the Federal Service on Surveillance in Healthcare and Social Development of Russian Federation

are being manufactured since 2011

the beginning of the production of the sirolimus-eluting coronary stent “Calipso”

international certificates are received in 2013

annual insurance coverage

according to the data prior June 2015

use company’s medical products according to the data as of June 2015

have been included into the register maintained by independent experts of The Moscow Department of Health N.V. Sklifosovsky Federal Research Institute of Emergency Medicine as a part of the study conducted in nine Russian clinics (Moscow, Novosibirsk, Barnaul, Tomsk, Krasnoyarsk, Vladivostok and Yaroslavl).

of endovascular procedures included into the register were successful.

new developments at the stage of certification.

the foundation for the development of the innovative and affordable treatments

Calypso next-generation coronary stents

Calypso next-generation coronary stents

Technical specifications

Stent material Stent coating material

Design

Foreshortening

Guiding catheter compatibilit

Nominal Pressure (NP)

Rated Burst Pressure (RBP)

Lesion Entry Profile

The material distal shaft

The material proximal shaft

Guide wire diameter

The period of sterility from the date of manufacture

Catheter type

Cobalt Chromium L605 PGA-PLA

Matrix

0%

4Fr (1,32 мм)

9 атм

18 атм

0,0165’’ (0,419 мм)

Nylon with hydrophilic coating

Hypotube stainless steel with PTFE coating

0,014’’

2 years

Rapid Exchange

Russian developer and producer of coronary stents

Innovation platform CALIPSO has the best Recoil rates

Innovation platform CALIPSO is not inferior to the best foreign counterparts in radial stiffness

Innovation platform CALIPSO has the best bending stiffness rates

Innovation platform CALIPSO provides optimal balance between radial and bending stiffness rates.

Bending stiffness rate

Rad

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tiff

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ss a

t 8

0%

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Innovation platform CALIPSO has the same drug excretion profiles as the best foreign counterparts

Innovation platform CALIPSO has the same drug excretion profiles as the best foreign counterparts

Innovation platform CALIPSO has the drag from the same Limus - group as the best foreign counterparts

Sirolimus Everolimus (Abbott) Zotarolimus (Medtronic)

Innovation platform CALIPSO trial results

According to the trial results* the stent`s key characteristics such as conduction, radial stability, fatigue resistance and recoil are highly competitive with the features of the best world analogues. The stent has one of the best value of the adaptiveness to vessels.

* trials were performed using the stand model. Parameters can be provided upon request. Error estimate is 4%.

Register stent by Angioline

N = 2411 • in the hospitals in 7 regions and 9 clinics in Russia (2012-2013) • 68% - acute coronary syndrome (ACS) • Success rate 98.7%

Coordinating Chief Researcher Prof. Kokov L., Lopotovsky P. PhD, Porhomenko M. N.V.Sklifosovsky Research Institute of Emergency Medicine

2380 (98,7%)

9 (0,37%)

12 (0,5%)

10 (0,41%)

E-CALIPSO POSTMARKETING COMPARATIVE REGISTRY STUDY OF THE FIRST RUSSIAN BIORESORBABLE DRUG ELUTING CORONARY STENT “CALIPSO” (ANGIOLINE INTERVENTIONAL DEVICE) VERSUS RESOLUTE INTEGRITY CORONARY STENT (MEDTRONIC INC.)

Scientific coordinator Alexey Sozykin, MD, PhD

Start February 2015 Finish July 2016

Medical Centers 1. Moscow

2. Moscow

E-CALIPSO

Schematic diagram of study design

E-CALIPSO POSTMARKETING COMPARATIVE REGISTRY STUDY OF THE FIRST RUSSIAN BIORESORBABLE DRUG ELUTING CORONARY STENT “CALIPSO” (ANGIOLINE INTERVENTIONAL DEVICE) VERSUS RESOLUTE INTEGRITY CORONARY STENT (MEDTRONIC INC.)

RANDOMIZATION 1:1

Calipso group (CALIPSO stent)

Resolute Integrity group (Resolute Integrity stent)

Enrollment period Admission period

Т2 Т3

- Assessment of clinical and laboratory parameters

- stent implantation, assessment of clinical and laboratory parameters

Т0 Т4

6-9 months follow-up visit

PCI PROCEDURE

Т1

30 days follow-up visit

PATRIOT

A Single-blind, Prospective, rAndomized, MulTicenter Study evaluating Efficacy and Safety of SirRolimus-DelIvering CALYPSO CorOnary StenT Versus Everolimus-Delivering Xience Prime (Abbott Vascular) coronary stent

Start March 2015 Finish December 2016

Comparison of efficacy and safety of Calypso Angioline stents versus Xience Prime Abbott Vascular stents

Objective of the study

1. Moscow 2. Moscow 3. Orenburg 4. Vladivostok 5. Krasnoyarsk 6. Kemerovo

Medical Centers

Study tasks To demonstrate non-inferiority of Calipso stents to Xience Prime in terms of clinical efficacy

Administration of study

Coordinating Chief Researcher

Monitoring data

Angiography laboratory

Ethical support

The independent clinical events committee

Eugene Kretov Ye. N. Meshalkin Novosibirsk Research Institute of Circulation Pathology

Research organization «AmeRuss Clinical Trials»

Vitaly Baystrukov Ye. N. Meshalkin Novosibirsk Research Institute of Circulation Pathology

Independent Interdisciplinary Committee on Ethical Review Moscow

Bagrat G. Alekyan President of Russian Scientific Society of Endovascular Therapies

Schematic diagram of study design

A Single-blind, Prospective, Randomized, Multicenter Study evaluating Efficacy and Safety of Sirolimus-Delivering CALYPSO Coronary Stent Versus Everolimus-Delivering Xience Prime (Abbott Vascular) coronary stent (PATRIOT)

Calipso N=406

Xience Prime N=204

Efficacy endpoints

Primary endpoint (combined):

1. Complication related to target lesion within 1 year determined as cardiac death, target-artery-

related myocardial infarction, or clinically indicated revascularization of the target lesion.

Secondary endpoints:

1. Individual components of the primary endpoint: death due to any cause; Q-positive and Q-

negative myocardial infarction; clinically indicated target-vessel revascularization, any target-

vessel revascularization, any target-lesion revascularization, or stent thrombosis (determined,

possible, or probable).

2. Late luminal loss (in the stent) (follow-up:12 months)

3. Device implantation success, lesion treatment success, and procedure success.

Efficacy endpoints

1. Patient of < 18 and > 75 y.o.

2. Acute coronary syndrome with ST elevation

3. Patients not tolerating anticoagulants/disaggregants

4. Severe valve pathology requiring an operation within 1 year

5. Glomerular filtration rate<30 mL/min

6. Anemia <100 g/L

7. Thrombocytopenia

8. Oncology

9. Ongoing bleeding

10. Clinical signs and/or symptoms of NYHA class IV heart failure at the time of selection or enrollment.

11. Heart failure hospitalization as a main diagnosis in the last 12 months.

12. Lesion of coronary arteries requiring coronary artery bypass grafting

1. Patients of either sex 18-75 y.o. with stable coronary heart disease or acute coronary syndrome having indications to revascularization by means of angioplasty with stenting.

2. Patients with a target lesion localized in a coronary artery with the reference diameter from 2.5 to 4 mm and >50% stenosis.

3. Signed informed consent.

Inclusion criteria: Exclusion criteria:

Calypso meets the standards and performance of the best competitors made equipment in its class at significant cost savings.

Thank you

www.angioline.ru